PREN 1422 : DRAFT 2011
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
99/562423 DC : DRAFT APR 99
|
BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS |
DIN EN ISO 13408-3 E : 2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION (ISO 13408-3:2006) |
DIN EN ISO 20857 E : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
CSA ISO 11607-1 : 2016
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
ISO 16971 : 2015
|
OPHTHALMIC INSTRUMENTS - OPTICAL COHERENCE TOMOGRAPH FOR THE POSTERIOR SEGMENT OF THE HUMAN EYE |
BS ISO 15198 : 2004
|
CLINICAL LABORATORY MEDICINE - IN VITRO DIAGNOSTIC MEDICAL DEVICES - VALIDATION OF USER QUALITY CONTROL PROCEDURES BY THE MANUFACTURER |
CSA ISO 15197 : 2015
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
03/104519 DC : DRAFT FEB 2003
|
BS ISO 11737-3 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA |
BS EN ISO 15194 : 2009
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
I.S. EN ISO 11073-00103:2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
ASME PVHO 1 : 2016
|
SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY |
UNE-EN ISO 25539-2:2013
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
CSA Z17665-2 : 2009 : FR(R2019)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
AAMI ISO TIR 12417 : 2011
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
DIN EN ISO 81060-1 : 2012
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007) |
ISO 14708-1 : 2014
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
ISO TR 16142 : 2006
|
MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
DIN EN ISO 20072 : 2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
ISO TR 20520 : 1ED 2018
|
TRADITIONAL CHINESE MEDICINE - INFECTION CONTROL FOR ACUPUNCTURE TREATMENT |
BS EN 15224 : 2016
|
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE |
DIN EN ISO 11135-1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CEN/TR 15253 : 2005
|
HEALTH INFORMATICS - QUALITY OF SERVICE REQUIREMENTS FOR HEALTH INFORMATION INTERCHANGE |
PREN ISO 14160 : DRAFT 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN 13795 : 2013
|
SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
04/30048118 DC : DRAFT MAY 2004
|
BS EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNI EN ISO 81060-1 : 2012
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
UNI EN ISO 26782 : 2009
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
ISO 13960 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - PLASMAFILTERS |
BS EN ISO 80601-2-13 : 2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
04/30081279 DC : DRAFT MAY 2004
|
BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
I.S. EN ISO 5359:2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
AAMI ISO 20857 : 2010 : R2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
14/30270462 DC : 0
|
BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
BS EN ISO 20072 : 2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
AAMI SW87 : 2012
|
APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS |
BS EN ISO 20857 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
PREN 556-2 : DRAFT 2014
|
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
I.S. EN ISO 81060-1:2012
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007) |
ISO 14708-7 : 2013
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
BS ISO 13408-7 : 2012
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS |
BS EN ISO 25539-1 : 2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
BS EN ISO 25424 : 2011
|
STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
PREN 17180 : DRAFT 2017
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
AAMI TIR36 : 2007
|
VALIDATION OF SOFTWARE FOR REGULATED PROCESSES |
14/30244508 DC : 0
|
BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
VDI/VDE 2657-1 : 2013
|
MIDDLEWARE IN INDUSTRIAL AUTOMATION - FUNDAMENTALS |
CSA Z11137-3 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
BS EN ISO 13408-3 : 2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION (ISO 13408-3:2006) |
BS ISO 17218 : 2014
|
STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE |
AAMI IEC TIR 80002-1 : 2009
|
MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE |
08/30192448 DC : DRAFT DEC 2008
|
BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
UNI EN ISO 21649 : 2009
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
CSA Z11140.1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
DIN EN ISO 13504 E : 2012
|
DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
13/30250915 DC : 0
|
BS EN 62353 - MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
05/30106194 DC : 0
|
EN ISO 22442-2 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
15/30281262 DC : 0
|
BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
BS ISO 16142-2 : 2017
|
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
10/30196945 DC : 0
|
BS ISO 25539-3 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
13/30285624 DC : 0
|
BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
DIN EN ISO 7199 E : 2017
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
BS PD IEC TR 60601-4-1 : 2017
|
MEDICAL ELECTRICAL EQUIPMENT - PART 4-1: GUIDANCE AND INTERPRETATION - MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS EMPLOYING A DEGREE OF AUTONOMY |
AAMI ISO 10993-1 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
17/30359001 DC : 0
|
BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF ASPECTS OF SAFETY IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
I.S. EN 82304-1:2017
|
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
UNE EN 13795 : 2011
|
SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
AAMI ISO 81060-1 : 2007
|
NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
UNE EN ISO 11608-5 : 2013
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
UNE EN ISO 16061 : 2015
|
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
07/30169357 DC : 0
|
BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS |
UNE EN ISO 7198 : 2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
12/30262894 DC : 0
|
BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
17/30363625 DC : DRAFT SEP 2017
|
BS EN ISO 11138-7 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 7: GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
BS PD ISO/TR 27809 : 2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING PATIENT SAFETY OF HEALTH SOFTWARE |
02/124462 DC : DRAFT DEC 2002
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
10/30236480 DC : 0
|
BS EN 16224 - HEALTH CARE PROVISION BY CHIROPRACTORS |
BS EN ISO 14155 : 2011
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
BS ISO/IEEE 11073-00103 : 2015
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
AAMI ISO 14937 : 2009 : R2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
01/561789 DC : DRAFT APR 2001
|
BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS |
PREN ISO 11135 : DRAFT 2011
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011) |
DIN EN ISO 5840-1 E : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015) |
15/30328959 DC : 0
|
BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
BS EN ISO 7198 : 2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
PREN 45502-1 : DRAFT 2013
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
EN ISO 5359 : 2014 AMD 1 2017
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017) |
I.S. EN ISO 25539-2:2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
BS ISO 18362 : 2016
|
MANUFACTURE OF CELL-BASED HEALTH CARE PRODUCTS - CONTROL OF MICROBIAL RISKS DURING PROCESSING |
AAMI ISO 22442-2 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
15/30246774 DC : 0
|
BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
AAMI ISO 11607-1 : 2006 : INC : AMD 1 : 2014 : R201000
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
DIN EN ISO 12870 E : 2014
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012) |
DIN EN ISO 15194 : 2009
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
BS ISO 8009 : 2014
|
MECHANICAL CONTRACEPTIVES - REUSABLE NATURAL AND SILICONE RUBBER CONTRACEPTIVE DIAPHRAGMS - REQUIREMENTS AND TESTS |
UNI EN ISO 11135 : 2014
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 11737-1 : 2006
|
STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
11/30243761 DC : 0
|
BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
DIN EN ISO 5840-3 E : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
ISO 29942:2011(R2016)
|
PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS |
AAMI TIR52 : 2014 : R2017
|
ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
15/30317874 DC : 0
|
BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
BS ISO 15675 : 2009
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
ISO 8637-1 : 2017
|
EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
EN ISO 12870 : 2018
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2016) |
BS ISO 25841 : 2017
|
FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS |
CSA PLUS 15189 : 2010
|
THE ISO 15189:2007 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 15189:2007 STANDARD FOR MEDICAL LABORATORIES |
ISO TR 27809 : 2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING PATIENT SAFETY OF HEALTH SOFTWARE |
08/30149503 DC : DRAFT JAN 2008
|
BS EN ISO 14161 - STERILIZATION OF HEALTH CAR PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
12/30261215 DC : 0
|
BS EN 13060 - SMALL STEAM STERILIZERS |
16/30347647 DC : 0
|
BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
BS EN ISO 5840-2 : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
ASTM F 2633 : 2013 : REDLINE
|
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
BS EN 16372 : 2014
|
AESTHETIC SURGERY SERVICES |
I.S. EN ISO 14155:2011
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
EN ISO 13408-2 : 2018
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018) |
16/30331656 DC : 0
|
BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS |
SR CEN/TR 15640:2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
I.S. EN ISO 13504:2012
|
DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
10/30203224 DC : 0
|
BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
AAMI ISO TIR 11139 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
BS PD IEC PAS 63077 : 2016
|
GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT |
I.S. EN ISO 11137-1:2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
BS EN ISO 13504 : 2012
|
DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
ISO 11607-2 : 2006(R 2015)
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
AAMI ISO TIR 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
BS PD IEC TR 80002-3 : 2014
|
MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) |
I.S. CEN ISO/TR 14969:2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
ISO 11737-3 : 2004
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA |
BS EN 82304-1 : 2017
|
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
01/563350 DC : DRAFT AUG 2001
|
BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
11/30219230 DC : 0
|
BS ISO 13175-3 - IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES |
AAMI ST90 : 2017
|
PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES |
DIN EN ISO 13408-7 E : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012) |
AAMI ISO TIR 15499 : 2017
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
UNE EN ISO 13504 : 2013
|
DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
DIN EN ISO 11608-5 : 2013
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
16/30346829 DC : 0
|
BS ISO 16038 - MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT CONDOMS |
15/30282559 DC : 0
|
BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL |
PREN 13795-1 : DRAFT 2017
|
SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
14/30251609 DC : 0
|
BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
BS PD ISO/TS 17665-3 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
BS PD IEC TR 62366-2 : 2016
|
MEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
PREN ISO 11140-1 : DRAFT 2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO/DIS 11140-1:2012) |
16/30331650 DC : 0
|
BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
DD ISO/TS 12417 : 2011
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
DIN EN ISO 12417-1 : 2016
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
17/30358658 DC : 0
|
BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
BS ISO 27427 : 2013
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
BS PD CEN/TR 15640 : 2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
I.S. EN 62366-1:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
I.S. EN ISO 13408-1:2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
UNE EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
DIN EN ISO 18113-1 : 2013
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
BS ISO 16840-6 : 2015
|
WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES OF SEAT CUSHIONS |
AAMI ISO 22442-3 : 2007
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
14/30281557 DC : 0
|
BS EN ISO 7198 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES |
13/30283636 DC : 0
|
BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS |
BS PD IEC TR 80001-2-2 : 2012
|
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS |
11/30219211 DC : 0
|
BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
16/30334735 DC : 0
|
BS EN 15224 - HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015 |
UNE EN ISO 20857 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
04/30048584 DC : DRAFT MAY 2004
|
BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
I.S. EN ISO 20857:2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
07/30157023 DC : 0
|
BS EN ISO 15194 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
DIN EN ISO 11607-1 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
BS EN ISO 81060-1 : 2012
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
DIN EN ISO 26782 : 2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
AAMI TIR52:2014
|
ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
BS EN ISO 12417-1 : 2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
17/30250386 DC : 0
|
BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS |
BS PD ISO/TS 17822-1 : 2014
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - QUALITATIVE NUCLEIC ACID-BASED IN VITRO EXAMINATION PROCEDURES FOR DETECTION AND IDENTIFICATION OF MICROBIAL PATHOGENS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS |
04/30078095 DC : DRAFT JUL 2004
|
ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 15675 : 2016
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
08/30179586 DC : DRAFT MAR 2008
|
BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
VDI 5702-1 : 2017
|
MEDICAL DEVICE SOFTWARE - MEDICAL SPICE PROCESS ASSESSMENT MODEL |
DIN ISO 13022 E : 2014
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
AAMI IEC TIR 80001-2-2 : 2012
|
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS |
DIN EN ISO 5359 E : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
11/30252448 DC : 0
|
BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
ISO/TS 15843 : 2000
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT FAMILIES AND SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS, AND FREQUENCY OF STERILIZATION DOSE AUDITS |
AAMI ISO 13408-3 : 2006 : R2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION |
SR CEN/TR 17223:2018
|
GUIDANCE ON THE RELATIONSHIP BETWEEN EN ISO 13485: 2016 (MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES) AND EUROPEAN MEDICAL DEVICES REGULATION AND IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION |
I.S. EN ISO 11737-1:2018&LC:2018
|
STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018) |
ANSI/AAMI/ISO 11607-1:2006/(R)2015
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
ISO TS 11139 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
04/300654 DC : DRAFT JAN 2004
|
BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
EN ISO 7396-1 : 2016
|
MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
NBR ISO 7199 : 1998
|
IMPLANTES CARDIOVASCULARES E ORGAOS ARTIFICIAIS - OXIGENADORES DE SANGUE EXTRACORPOREOS (TROCADORES DE GAS-SANGUE) |
BS ISO 17593 : 2007
|
CLINICAL LABORATORY TESTING AND IN VITRO MEDICAL DEVICES - REQUIREMENTS FOR IN VITRO MONITORING SYSTEMS FOR SELF-TESTING OF ORAL ANTICOAGULANT THERAPY |
ISO 15198 : 2004
|
CLINICAL LABORATORY MEDICINE - IN VITRO DIAGNOSTIC MEDICAL DEVICES - VALIDATION OF USER QUALITY CONTROL PROCEDURES BY THE MANUFACTURER |
13/30232902 DC : 0
|
BS ISO 14708-1 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
UNE EN ISO 25539-3 : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
AAMI ISO 13408-1 : 2008
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
14/30273161 DC : 0
|
BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
BS EN ISO 18113-1 : 2011
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
BS EN ISO 25539-3 : 2011
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
CSA ISO 14971: 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI ISO 10993-1 : 2009
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
09/30180393 DC : 0
|
BS EN ISO 10451 - DENTISTRY - CONTENTS OF TECHNICAL FILE FOR DENTAL IMPLANT SYSTEMS |
11/30208525 DC : 0
|
BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
13/30259011 DC : 0
|
BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE |
BS PD ISO/TR 15499 : 2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
14/30302761 DC : 0
|
BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS) |
NBR ISO 11135 : 2018
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
13/30255929 DC : 0
|
BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM |
DIN EN 16224 E : 2015
|
HEALTHCARE PROVISION BY CHIROPRACTORS |
UNI EN ISO 25424 : 2011
|
STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 25539-1 : 2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
17/30351720 DC : 0
|
BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
ISO 12870 : 2016
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS |
AAMI ISO 81060-1 : 2007
|
NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
14/30287753 DC : 0
|
BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
BS ISO 15378 : 2006 AMD 17315
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
15/30321502 DC : 0
|
BS EN ISO 11138-1 - STERILIZATION OF HEALTH PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
BS EN ISO 13408-7 : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS |
15/30321715 DC : 0
|
BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
17/30357741 DC : 0
|
BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
I.S. EN ISO 13408-2:2018
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018) |
DIN EN ISO 25539-2 E : 2013
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
DIN EN ISO 18113-1 E : 2013
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
16/30346073 DC : 0
|
BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
09/30195717 DC : 0
|
BS ISO 29942 - PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS |
06/30112971 DC : DRAFT JULY 2006
|
ISO/IEC 62366 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
AAMI ISO 20857 : 2010
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS ISO 29942 : 2011
|
PROPHYLACTIC DAMS - REQUIREMENTS AND TEST METHODS |
12/30251858 DC : 0
|
BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS |
16/30312836 DC : 0
|
BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS |
DD CEN/TS 15224 : 2005
|
HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9001:2000 |
DIN EN ISO 14155 E : 2012
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
BS ISO 13175-3 : 2012
|
IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES |
10/30213842 DC : 0
|
BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
04/30101211 DC : DRAFT APR 2004
|
ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
BS ISO 29943-2 : 2017
|
CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
DD CEN ISO/TS 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
AAMI ISO 11607-1 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
UNE-EN ISO 11607-2:2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006) |
AAMI ISO 7199 : 2009
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
14/30290166 DC : 0
|
BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
13/30233325 DC : 0
|
BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
17/30302489 DC : DRAFT MAR 2017
|
BS EN ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
UNI EN ISO 13504 : 2012
|
DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
BS PD ISO/TR 14969 : 2004 AMD 15958
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
BS EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
BS PD ISO/TR 22979 : 2017
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - GUIDANCE ON ASSESSMENT OF THE NEED FOR CLINICAL INVESTIGATION OF INTRAOCULAR LENS DESIGN MODIFICATIONS |
BS ISO 16038 : 2017
|
MALE CONDOMS - GUIDANCE ON THE USE OF ISO 4074 AND ISO 23409 IN THE QUALITY MANAGEMENT OF CONDOMS |
UNE EN 62304 : 2007
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
BS ISO 16142-1 : 2016
|
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
DIN EN ISO 11607-2 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
ASTM F 1108 : 2014 : REDLINE
|
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
I.S. EN ISO 11135:2014
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
I.S. EN ISO 5840-3:2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
17/30344601 DC : 0
|
BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
14/30281560 DC : 0
|
BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
BS ISO 11658 : 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
DIN EN 16224 : 2015
|
HEALTHCARE PROVISION BY CHIROPRACTORS |
13/30278952 DC : 0
|
BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
DIN EN ISO 13408-1 : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
VDI 2083-8-1 : 2014
|
Cleanroom technology - Air cleanliness chemical concentration (ACC)
|
14/30292011 DC : 0
|
BS EN ISO 23747 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS |
DIN EN ISO 26782 E : 2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
12/30252545 DC : 0
|
BS ISO 15883-1:2006/AMD - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
11/30244091 DC : 0
|
BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 15197 E : 2015
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOODGLUCOSE MONITORING SYSTEMS FOR SELFTESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
I.S. EN 16844:2017
|
AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
03/304741 DC : DRAFT APR 2003
|
IEC 60601-1-6 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - USABILITY |
17/30332162 DC : 0
|
BS EN ISO 7494-1 - DENTISTRY - STATIONARY DENTAL UNITS AND DENTAL PATIENT CHAIRS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
DIN EN ISO 16061 : 2015
|
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
ISO 13179-1 : 2014
|
IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON METALLIC SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS |
04/30081258 DC : DRAFT MARCH 2004
|
BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS |
14/30287226 DC : 0
|
BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
PREN 14180 : DRAFT 2012
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
AAMI ISO 10993-1 : 2009 : R2013
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
DIN EN 15224 : 2016
|
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE |
ANSI/AAMI/ISO 11607-1:2006/(R)2015
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
BS PD CEN ISO/TR 14969 : 2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
08/30179589 DC : DRAFT MAR 2008
|
BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
16/30310949 DC : 0
|
BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
CSA ISO/TS 11139 : 2018
|
STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
04/30048301 DC : DRAFT MAY 2004
|
BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS ISO 18385 : 2016
|
MINIMIZING THE RISK OF HUMAN DNA CONTAMINATION IN PRODUCTS USED TO COLLECT, STORE AND ANALYZE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES - REQUIREMENTS |
UNI CEI EN 1041 : 2013
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
17/30302770 DC : 0
|
BS ISO 13779-3 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 3: CHEMICAL ANALYSIS AND CHARACTERIZATION OF CRYSTALLINITY RATIO AND PHASE PURITY |
09/30157765 DC : 0
|
BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 7198 : 2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
BS EN ISO 15378 : 2017
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
DIN EN ISO 25424 E : 2011
|
STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 25424:2009) |
I.S. EN ISO 18113-1:2011
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
DIN EN 15224 E : 2017
|
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE |
BS ISO 23409 : 2011
|
MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS |
ISO 13683 : 1997
|
STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL OF MOIST HEAT STERILIZATION IN HEALTH CARE FACILITIES |
UNE EN 62353 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
BS EN 62366 : 2008
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
ISO 13175-3 : 2012
|
IMPLANTS FOR SURGERY - CALCIUM PHOSPHATES - PART 3: HYDROXYAPATITE AND BETA-TRICALCIUM PHOSPHATE BONE SUBSTITUTES |
13/30280551 DC : 0
|
BS ISO 16840-6 - WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES - SEAT CUSHIONS |
DIN EN 13795 E : 2013
|
SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
BS EN ISO 11608-5 : 2012
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
DIN EN ISO 13408-1 E : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
I.S. EN 62366-1:2015&AC:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
BS EN ISO 7199 : 2017
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
BS ISO 13179-1 : 2014
|
IMPLANTS FOR SURGERY - PLASMA-SPRAYED UNALLOYED TITANIUM COATINGS ON METALLIC SURGICAL IMPLANTS - PART 1: GENERAL REQUIREMENTS |
11/30212235 DC : 0
|
BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT |
15/30321712 DC : 0
|
BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
14/30267655 DC : 0
|
BS ISO 13779-6 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 6: POWDERS |
BIP 2071 : 2005
|
MEDICAL DEVICES: ISO 13485 AND ISO 9001 |
12/30238553 DC : 0
|
BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
15/30321957 DC : 0
|
BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS) |
08/30138762 DC : DRAFT APR 2008
|
BS EN ISO 11980 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS |
DIN EN ISO 25539-3 : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
CSA Z14161 : 2011 : R2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
EN 82304-1 : 2017
|
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY (IEC 82304-1:2016) |
13/30278676 DC : 0
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
CSA Z11137-3 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
12/30212355 DC : 0
|
BS ISO 13179-1 - IMPLANTS FOR SURGERY - PLASMA SPRAYED COATINGS OF UNALLOYED TITANIUM - PART 1: GENERAL REQUIREMENTS |
DIN EN ISO 25539-3 E : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
DIN EN ISO 7396-1 E : 2016
|
MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
17/30349163 DC : 0
|
BS ISO 20387 - BIOTECHNOLOGY - BIOBANKING - GENERAL REQUIREMENTS FOR BIOBANKING |
BS EN ISO 26782 : 2009
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
DD CEN ISO/TS 11135-2 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 (ISO/TS 11135-2:2008) |
BS ISO 18666 : 2015
|
TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
AAMI ISO 11138-1 : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
16/30302485 DC : 0
|
BS EN ISO 11737-1 - STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCT |
DIN EN ISO 25539-1 E : 2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
05/30106198 DC : 0
|
EN ISO 22442-3 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
CSA Z17665-2 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
SR CEN ISO/TS 17665-2:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
14/30255138 DC : 0
|
BS EN ISO 11607-2:2006/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
BS PD CR 12401 : 2003
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
NEMA/MITA 1 : 2015
|
GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT |
14/30289934 DC : 0
|
BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES |
07/30164697 DC : 0
|
ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS EN ISO 11073-00103 : 2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
03/314215 DC : DRAFT OCT 2003
|
ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
BS PD CEN/TR 15253 : 2005
|
HEALTH INFORMATICS - QUALITY OF SERVICE REQUIREMENTS FOR HEALTH INFORMATION INTERCHANGE |
12/30244415 DC : DRAFT APR 2012
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
06/30146511 DC : 0
|
BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
17/30338806 DC : 0
|
BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
14/30296035 DC : 0
|
BS ISO 29943-2 - CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
BS PD ISO/TR 80002-2 : 2017
|
MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS |
AAMI ISO TIR 14969 : 2004
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
AAMI ISO 81060-1 : 2007 : R2013
|
NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
BS EN ISO 5840-1 : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
15/30329923 DC : 0
|
BS EN ISO 22610 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION |
UNE EN 16372 : 2015
|
AESTHETIC SURGERY SERVICES |
NF CEN ISO/TS 11135-2 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
BS PD ISO/TR 13154 : 2017
|
MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH |
ASTM F 3055 : 2014A
|
SPECIFICATION FOR ADDITIVE MANUFACTURING NICKEL ALLOY (UNS N07718) WITH POWDER BED FUSION |
BS ISO 8009-1 : 1997
|
REUSABLE RUBBER CONTRACEPTIVE DIAPHRAGMS - CLASSIFICATION, SAMPLING AND REQUIREMENTS |
BS EN 45502-2-3 : 2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
04/30048205 DC : DRAFT JUL 2004
|
BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 11138-1 E : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
03/103026 DC : DRAFT JAN 2003
|
BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
14/30266295 DC : 0
|
BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS |
DIN EN ISO 11135 : 2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
17/30343656 DC : 0
|
BS ISO 21426 - TOURISM AND RELATED SERVICES - MEDICAL SPA - SERVICE REQUIREMENTS |
16/30338304 DC : 0
|
BS ISO/ASTM 52903-1 - ADDITIVE MANUFACTURING - STANDARD SPECIFICATION FOR MATERIAL EXTRUSION BASED ADDITIVE MANUFACTURING OF PLASTIC MATERIALS - PART 1: FEEDSTOCK MATERIALS |
DIN EN ISO 13408-7 : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012) |
04/30090376 DC : DRAFT DEC 2004
|
ISO 13408-3 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION |
AAMI ISO 25539-2 : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
PREN 285 : DRAFT 2013
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
06/30106186 DC : 0
|
ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
BS EN 62366-1 : 2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
11/30227618 DC : 0
|
BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
DIN EN ISO 13408-3 : 2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION |
04/30079743 DC : DRAFT APR 2004
|
ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
CSA Z11137-3 : 2007 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
DIN EN ISO 11607-1 E : 2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1:2014) |
BS PD IEC TR 80002-1 : 2009
|
MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
17/30364306 DC : 0
|
BS EN 17180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
10/30208681 DC : DRAFT SEP 2010
|
BS ISO/IEC GUIDE 63 - GUIDE TO THE DEVELOPMENT AND INCLUSION OF SAFETY ASPECTS IN INTERNATIONAL STANDARDS FOR MEDICAL DEVICES |
07/30145258 DC : 0
|
BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
CSA Z11138-1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
I.S. EN ISO 11607-2:2017 & LC:2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014) |
ISO 16142-1 : 2016
|
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
16/30346835 DC : 0
|
BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
DIN EN ISO 81060-1 E : 2012
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007) |
ASTM E 3051 : 2016
|
Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing |
03/317861 DC : DRAFT OCT 2003
|
EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
AAMI IEC 62366 : 2015
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
ASTM F 2052 : 2015 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
CSA Z11137-2 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CSA IEC 62366 : 2014
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
12/30254927 DC : 0
|
BS EN 16372 - AESTHETIC SURGERY SERVICES |
UNI EN ISO 20072 : 2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
AAMI ISO 5840 : 2005 : R2010
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
BS ISO 15674 : 2009
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
CSA Z11137-2 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
15/30303073 DC : 0
|
BS ISO 25841 - FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS |
CSA C22.2 No. 60601.1 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
AAMI ISO 16142-2 : 2017
|
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
CSA Z11135-2 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
08/30179592 DC : DRAFT MAR 2008
|
BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
BS ISO 29943-1 : 2017
|
CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
BS ISO 81060-1 : 2007 COR 2012
|
NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE |
ISO 18385 : 2016
|
MINIMIZING THE RISK OF HUMAN DNA CONTAMINATION IN PRODUCTS USED TO COLLECT, STORE AND ANALYZE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES - REQUIREMENTS |
DIN EN ISO 14155 : 2012
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
16/30302520 DC : 0
|
BS ISO 19611 - TRADITIONAL CHINESE MEDICINE - AIR EXHAUST CUPPING APPARATUS FOR MEDICAL USE |
07/30157769 DC : DRAFT DEC 2007
|
BS EN ISO 11737-2 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS |
CSA Z11135-2 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
CSA Z1416: 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
BS EN 62353 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
CSA Z11135-1 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO TIR 16142 : 2005
|
MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
CSA Z11135 : 2015
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z11138-1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
CSA Z11137-2 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CSA ISO 14937 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 20857 : 2010
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA ISO TR 14969 : 2005 : R2010
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
I.S. CEN TS 15224:2006
|
HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9001:2000 |
CSA ISO 14971 : 2007 :R2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA Z14161 : 2011 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
UNE EN 15224 : 2017
|
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE |
CSA Z11137-3 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
ISO 29943-2 : 2017
|
CONDOMS - GUIDANCE ON CLINICAL STUDIES - GUIDANCE ON CLINICAL STUDIES - PART 2: FEMALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
CSA ISO TR 14969 : 2005 : R2015
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
AAMI ISO 11140-1 : 2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
BS ISO 25539-1 : 2003
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
BS ISO 16054 : 2000 AMD 14017
|
IMPLANTS FOR SURGERY - MINIMUM DATA SETS FOR SURGICAL IMPLANTS |
UNE EN ISO 13408-3 : 2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION (ISO 13408-3:2006) |
AAMI ISO 13408-1 : 2008 : R2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
AAMI ST72:2011
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
AAMI ST72 : 2011
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
ASTM F 3302 : 2018
|
Standard for Additive Manufacturing – Finished Part Properties – Standard Specification for Titanium Alloys via Powder Bed Fusion |
AAMI IEC TIR 80002-3 : 2016
|
MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) |
07/30090385 DC : 0
|
ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
UNE EN ISO 5840-1 : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
CSA Z11135-1 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 13022 : 2012
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
AAMI ISO 5840 : 2005
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
BS PD ISO/TR 16142 : 2006
|
MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
06/30137313 DC : 0
|
ISO/IEC 81060-1 - NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR MECHANICAL TYPE |
AAMI ISO 17665-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
SR CEN/CLC TR 14060:2014
|
MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI) |
CSA Z11138-1 : 2007 : R2012 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 22442-3 : 2007
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
08/30133979 DC : DRAFT MAY 2008
|
BS ISO 23409 - MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS |
ISO 11607-1 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
CSA ISO 14937 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
04/30101215 DC : DRAFT APR 2004
|
ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
EN ISO 11135 : 2014 COR 2014
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
AAMI ISO TIR 17665-3 : 2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
SR CR 14060:2000
|
MEDICAL DEVICE TRACEABILITY |
AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
NBR ISO 17665-1 : 2010
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
09/30197784 DC : 0
|
BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CSA ISO 14937 : 2011 :R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z11140.1 : 2007 : R2012 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 14160 : 2011 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z11135-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
ASTM F 2820 : 2012
|
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
CSA Z14161 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
UNI EN ISO 25539-2 : 2013
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
CSA Z11138-1 : 2007 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
CSA ISO 14937 : 2011 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNI EN 13795 : 2013
|
SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
CSA Z11137-2 : 2007 : R2012 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
AAMI ISO 22442-1 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
DIN EN ISO 7198 E : 2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
AAMI ISO TIR 17665-3 : 2014 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
CSA ISO 11138-1 : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
AAMI ISO 22442-3 : 2007 : R2011
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
BS EN ISO 11607-2 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
UNI CEN ISO/TS 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
I.S. EN 62366-1:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
AAMI TIR52 : 2014
|
ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS |
ISO/TR 12417-2:2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 2: LOCAL REGULATORY INFORMATION |
ISO 5910 : 2018
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES |
BIS IS/ISO 15197 : 2013
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEM FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
ISO 23409 : 2011(R2015)
|
MALE CONDOMS - REQUIREMENTS AND TEST METHODS FOR CONDOMS MADE FROM SYNTHETIC MATERIALS |
CSA ISO 14971 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
PREN 13060 : DRAFT 2012
|
SMALL STEAM STERILIZERS |
DIN EN ISO 20072 E : 2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
DIN EN ISO 16061 E : 2015
|
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
CSA Z11140.1 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
DIN EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013) |
CSA Z11137-3 : 2007 : R2012 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS |
DIN EN ISO 11608-5 E : 2013
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
CR 14060 : 2000
|
MEDICAL DEVICE TRACEABILITY |
ISO 11249 : 2018
|
COPPER-BEARING INTRAUTERINE CONTRACEPTIVE DEVICES - GUIDANCE ON THE DESIGN, EXECUTION, ANALYSIS AND INTERPRETATION OF CLINICAL STUDIES |
UNE EN ISO 15378 : 2016
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2015) |
CSA ISO 14971 : 2007 : R2017
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
GOST R ISO 13485 : 2004
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES |
CSA ISO 14971 : 2007 : R2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA Z11138-1 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
UNI EN ISO 15194 : 2009
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
UNI EN ISO 20857 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 25539-2 : 2013
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012) |
CSA ISO 14937 :2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 13408-1:2008
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
CSA ISO TR 14969 : 2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
AAMI ISO 12417-1 : 2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS |
CSA Z11140.1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
CSA Z11135-1 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA ISO 14971 : 2007:R2017
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
UNE EN ISO 22442-2 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING (ISO 22442-2:2015) |
UNE EN ISO 11135 : 2015
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
DIN EN ISO 20857 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010) |
DIN EN ISO 5840-2 : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
DIN ISO 13022 : 2014
|
MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
UNI EN ISO 11608-5 : 2013
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
AAMI IEC 62304 : 2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
IEC TR 80002-1 : 1.0
|
MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE |
DIN EN ISO 5840-1 : 2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
AAMI ST72 : 2011 : R2016
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
UNI EN ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
UNI EN 15927 : 2010
|
SERVICES OFFERED BY HEARING AID PROFESSIONALS |
I.S. EN ISO 7396-1:2016
|
MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
IEC 82304-1 : 1ED 2016
|
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
ISO TR 80002-2 : 2017
|
MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS |
BS EN 13795:2011+A1:2013
|
SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
15/30321242 DC : 0
|
BS EN ISO 12870 - OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS |
AAMI ISO 11737-1 : 2006
|
STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
I.S. EN 16844:2017+A2:2019
|
Aesthetic medicine services - Non-surgical medical treatments |
AAMI ISO 11607-1 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
ISO 16840-6 : 2015
|
WHEELCHAIR SEATING - PART 6: SIMULATED USE AND DETERMINATION OF THE CHANGES IN PROPERTIES OF SEAT CUSHIONS |
DIN EN ISO 7199 : 2015
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
ISO 19227 : 2018
|
IMPLANTS FOR SURGERY - CLEANLINESS OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS |
AAMI TIR45 : 2012
|
GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE |
BS ISO 13779-6 : 2015
|
IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 6: POWDERS |
AAMI ISO 11137-3 : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL |
ISO 17327-1 : 2018
|
NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS |
PREN 13795-2 : DRAFT 2017
|
SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
BS EN ISO 11607-1 : 2009
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
DIN EN ISO 25539-1 : 2015
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
BS EN ISO 11135 : 2014
|
STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS EN ISO 17664 : 2017
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
CSA Z11135-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
I.S. EN ISO 11608-5:2012
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
AAMI ISO 14971 : 2007 : R2010
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 11137-2 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
AAMI ISO 14161 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
NFPA 1991 : 2016
|
VAPOR-PROTECTIVE ENSEMBLES FOR HAZARDOUS MATERIALS EMERGENCIES AND CBRN TERRORISM INCIDENTS |
IEC TR 80001-2-2 : 1.0
|
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS |
AAMI ISO 11607-2 : 2006 : R2010
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
AAMI ISO TIR 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
CSA Z17665-1 : 2009(R 2019)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z17665-2 : 2009(R2019)
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
ISO 18362 : 2016
|
MANUFACTURE OF CELL-BASED HEALTH CARE PRODUCTS - CONTROL OF MICROBIAL RISKS DURING PROCESSING |
AAMI ISO 5840-3 : 2013
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES |
AAMI ISO 11607-2 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
BS ISO 7199 : 2009
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
UNE EN ISO 20072 : 2013
|
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
I.S. EN 16372:2014
|
AESTHETIC SURGERY SERVICES |
ISO 15378 : 2017
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
I.S. EN ISO 12870:2014
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2016) |
UNE EN ISO 14155 : 2012
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011) |
AAMI ISO 11137-2 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
BS EN ISO 13408-1 : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
ISO IWA 1 : 2005
|
QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR PROCESS IMPROVEMENTS IN HEALTH SERVICE ORGANIZATION |
DIN EN ISO 12870 : 2015
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012) |
PREN ISO 11137-2 : DRAFT 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CSA ISO 7199 : 0
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
AAMI ISO 5840-1 : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS |
I.S. EN 15927:2010
|
SERVICES OFFERED BY HEARING AID PROFESSIONALS |
I.S. EN ISO 26782:2009
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS |
BS EN ISO 7396-1 : 2016
|
MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM |
I.S. EN ISO 7198:2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
AAMI ISO 11137-1 : 2006 : R2010
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 11737-1 : 2009
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
IEEE 11073-00103 : 2012
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
SR CEN ISO/TS 11135-2:2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
AAMI ISO 14160 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
BS IEC 82304-1 : 2016
|
HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY |
ISO 25841 : 2017
|
FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS |
IEEE 730 : 2014
|
SOFTWARE QUALITY ASSURANCE PROCESSES |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
AAMI ISO 14160 : 2011
|
STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO TIR 17665-2 : 2009 : R2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
AAMI ISO 13408-7 : 2012(R2018)
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS |
AAMI ISO 14708-1 : 2014
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
AAMI ISO 25539-3 : 2011
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
CSA ISO 11137-3 : 2017
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL |
AAMI ISO 14937 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO TIR 17665-3 : 2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
I.S. EN ISO 5840-2:2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015) |
I.S. EN ISO 13408-7:2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012) |
EN 13060 : 2014
|
SMALL STEAM STERILIZERS |
AAMI ISO 11658 : 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
AAMI ISO 14937 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 17665-1 : 2006 : R2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 17665-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI TIR48 : 2015
|
QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS |
AAMI ISO 17664 : 2017
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
UNI CEN ISO/TS 11135-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
CSA Z17665-1 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO 11737-2 : 2009
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
I.S. EN 62353:2014
|
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
I.S. EN ISO 25424:2011
|
STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
AAMI ISO TIR 80002-2 : 2017
|
MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS |
I.S. EN 13060:2014
|
SMALL STEAM STERILIZERS |
AAMI ISO 11737-2 : 2009 : R2014
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
AAMI ISO 11737-2 : 2009
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
BS EN 16224 : 2012
|
HEALTHCARE PROVISION BY CHIROPRACTORS |
AAMI ISO 5840-2 : 2016
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
I.S. EN ISO 5840-1:2015
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015) |
AAMI ISO 15674 : 2016
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
AAMI ISO 13408-3 : 2006
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION |
AAMI ISO 11135 : 2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 5359 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
AAMI IEC 62366-1 : 2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
BS EN ISO 12870 : 2014
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS |
I.S. EN 45502-2-3:2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
ISO TR 14283 : 2018
|
IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE |
BS EN 62304 : 2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
ISO/TS 15539 : 2000
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR PROSTHESES |
UNI EN ISO 11737-1 : 2006
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
PREN 15224 : DRAFT 2016
|
HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015 |
I.S. EN ISO 11607-1:2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014) |
AAMI ISO 11135-1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
IEC TR 60601-4-1 : 2017
|
MEDICAL ELECTRICAL EQUIPMENT - PART 4-1: GUIDANCE AND INTERPRETATION - MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS EMPLOYING A DEGREE OF AUTONOMY |
ISO/DIS 11137-1 : 60.00 (2006)
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z5359 : 2016
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
BS EN ISO 5359 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
I.S. EN ISO 13408-3:2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION |
ISO 18562-1 : 2017
|
BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
AAMI ISO 11607-2 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
CEI UNI EN 1041 : 2014
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
ISO TS 17822-1 : 2014
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - QUALITATIVE NUCLEIC ACID-BASED IN VITRO EXAMINATION PROCEDURES FOR DETECTION AND IDENTIFICATION OF MICROBIAL PATHOGENS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS |
AAMI ISO 11737-1 : 2006 : R2011
|
STERILIZATION OF MEDICAL DEVICES - MEDICAL DEVICES - PART 1: DETERMINATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT |
CSA IEC 62366-1 : 2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
AAMI ISO 11607-2 : 2006 : INC : AMD 1 : 2014 : R201000
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
CSA Z17665-1:2009(R2019)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO/TR 15499:2016
|
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
ISO 16142-2 : 2017
|
MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
CSA ISO TR 13154 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH |
AAMI ISO 13408-2 : 2003
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
ISO 29943-1 : 2017
|
CONDOMS - GUIDANCE ON CLINICAL STUDIES - PART 1: MALE CONDOMS, CLINICAL FUNCTION STUDIES BASED ON SELF-REPORTS |
CSA Z17665-1 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNE EN ISO 22442-1 : 2016
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
ASTM F 2848 : 2017 : REDLINE
|
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
ISO TS 17665-3 : 2013(R2017)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 3: GUIDANCE ON THE DESIGNATION OF A MEDICAL DEVICE TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
CSA Z17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
ISO 17218 : 2014
|
STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE |
DIN EN ISO 7396-1 : 2016
|
MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
AAMI ST15883-1 : 2009
|
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
AAMI ISO 14155 : 2011
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE |
AAMI ST15883-1 : 2009 : INC : AMD 2 : 2012
|
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
UNI EN ISO 14155 : 2012
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE |
AAMI ISO 13408-2 : 2003 : R2013
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
UNE EN 15927 : 2011
|
SERVICES OFFERED BY HEARING AID PROFESSIONALS |
AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400
|
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS |
DIN EN ISO 11135 E : 2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
I.S. EN 16224:2012
|
HEALTHCARE PROVISION BY CHIROPRACTORS |
AAMI ISO 11137-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
I.S. EN 13795:2011
|
SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
AAMI ISO 11137-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
17/30358661 DC : 0
|
BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
UNE-EN ISO 11607-1:2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014) |
UNI EN ISO 11607-2 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
I.S. EN ISO 7199:2017
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
I.S. EN ISO 12417-1:2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
UNI EN ISO 18113-1 : 2012
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
EN ISO 11607-2 : 2017 COR 2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014) |
DIN EN ISO 5359 : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
UNI EN ISO 11607-1 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
I.S. EN ISO 25539-3:2011
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011) |
CEN/TR 15640 : 2007
|
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
CEN/CLC/TR 14060 : 2014
|
MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI) |
I.S. EN ISO 80601-2-13:2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
UNI EN ISO 25539-3 : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS |
ISO 18666 : 2015
|
TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
ASTM F 2181 : 2014 : REDLINE
|
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants |
ASTM F 3213 : 2017
|
Standard for Additive Manufacturing – Finished Part Properties – Standard Specification for Cobalt-28 Chromium-6 Molybdenum via Powder Bed Fusion |
AAMI ISO TIR 11135-2 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1 |
ASTM F 3184 : 2016
|
Standard Specification for Additive Manufacturing Stainless Steel Alloy (UNS S31603) with Powder Bed Fusion |
PREN ISO 15197 : DRAFT 2011
|
IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
ASTM F 3091/F3091M : 2014
|
Standard Specification for Powder Bed Fusion of Plastic Materials |
ASTM F 648 : 2014 : REDLINE
|
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
ASTM F 3001 : 2014 : REDLINE
|
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion |
UNI EN ISO 13408-3 : 2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION |
ASTM F 3056 : 2014 : EDT 1
|
Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion |
ASTM F 3056 : 2014
|
SPECIFICATION FOR ADDITIVE MANUFACTURING NICKEL ALLOY (UNS N06625) WITH POWDER BED FUSION |
CSA ISO TR 14969 : 2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
UNI EN 16224 : 2014
|
HEALTHCARE PROVISION BY CHIROPRACTORS |
ASTM F 3268 : 2018
|
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
CSA ISO 11140-1 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
UNE-EN ISO 25424:2011
|
STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 25424:2009) |
UNE-EN 13060:2015
|
SMALL STEAM STERILIZERS |
ASTM F 3160 : 2016
|
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
ASTM F 2257 : 2014 : REDLINE
|
Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673) |
ASTM F 2943 : 2014 : REDLINE
|
Standard Guide for Presentation of End User Labeling Information for Musculoskeletal Implants |
AAMI ISO 14971 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
ASTM F 2026 : 2017 : REDLINE
|
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
ASTM F 3055 : 2014
|
Standard Specification for Additive Manufacturing Nickel Alloy (UNS N07718) with Powder Bed Fusion |
I.S. EN ISO 15194:2009
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
ISO TS 12417 : 2011
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
EN ISO 17664 : 2017
|
PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
ISO 15194 : 2009(R2015)
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
ISO 16054 : 2000(R2010)
|
IMPLANTS FOR SURGERY - MINIMUM DATA SETS FOR SURGICAL IMPLANTS |
UNE EN ISO 7396-1 : 2016
|
MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
ISO 13779-6 : 2015
|
IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 6: POWDERS |
BS EN ISO 25539-2 : 2012
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS |
UNE-EN ISO 12870:2014
|
OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012) |
15/30282343 DC : 0
|
BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES |
BS EN ISO 16061 : 2015
|
INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
EN ISO 15378 : 2017
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
CSA Z11135-1 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 19611 : 2017
|
TRADITIONAL CHINESE MEDICINE - AIR EXTRACTION CUPPING DEVICE |
04/30089749 DC : DRAFT DEC 2004
|
BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
BS ISO 18562-1 : 2017
|
BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
BS EN 15927 : 2010
|
SERVICES OFFERED BY HEARING AID PROFESSIONALS |
DIN EN ISO 15194 E : 2009
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
ISO TR 14969 : 2004
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
CSA CEI/IEC 62304 : 2014(R2019)
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
I.S. EN 15224:2016
|
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE |
AAMI ISO 13408-2 : 2003
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION |
I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
ISO 11658 : 2012(R2017)
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
ISO 15675 : 2016
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CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
AAMI ISO 10993-1 : 2009 : INC : ERR 1 : 2013
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
UNE EN ISO 18113-1 : 2012
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
ASTM F 3056 : 2014
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Standard Specification for Additive Manufacturing Nickel Alloy (UNS N06625) with Powder Bed Fusion |
ASTM F 2924 : 2014 : REDLINE
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Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion |
ISO 17593 : 2007
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