PREN 1422 : DRAFT 2011
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
BS EN 1865-3 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
DIN EN 15908 : 2011
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
BS PD CEN/TR 12401 : 2009
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
UNI EN 15908 : 2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
DIN EN 80369-5 E : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
10/30215051 DC : DRAFT JUNE 2010
|
BS EN 1865-4 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: MECHANICAL ASSISTED TRANSFER CHAIR |
I.S. EN ISO 11073-00103:2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
MEDDEV 2.7-2 : REV 2
|
GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC |
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 |
12/30248648 DC : DRAFT AUG 2012
|
BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES |
06/30116855 DC : 0
|
BS ISO 10524-4 - PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS INTENDED FOR INCORPORATION INTO MEDICAL EQUIPMENT |
PREN 17180 : DRAFT 2017
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
04/30088537 DC : DRAFT SEP 2004
|
PREN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINES FOR COMPRESSED MEDICAL GASES AND VACUUM |
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) |
BS EN ISO 25539-1 : 2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
UNI CEN/TS 15277 : 2007
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
DIN EN 1865-1 E : 2015
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
BS EN ISO 26722 : 2015
|
WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES |
BS EN 16442 : 2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
BS EN ISO 5359 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
BS ISO/IEEE 11073-00103 : 2015
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
12/30262894 DC : 0
|
BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
04/30084857 DC : DRAFT JUN 2004
|
BS EN ISO 10524-1 - PRESSURE REGULATORS FOR USE WITH MEDICAL GAS SYSTEMS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
DIN EN ISO 13958 E : 2016
|
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
CEI EN 61082-1 : 2016
|
PREPARATION OF DOCUMENTS USED IN ELECTROTECHNOLOGY - PART 1: RULES |
BS EN ISO 7198 : 2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
02/124462 DC : DRAFT DEC 2002
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
PREN 45502-1 : DRAFT 2013
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
DIN EN 1865-1 : 2015
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN 16844:2017
|
AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
DIN EN 1865-2 : 2015
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
08/30184602 DC : DRAFT SEP 2008
|
BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
14/30289772 DC : 0
|
BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES |
15/30317874 DC : 0
|
BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
DIN EN 1865-3 E : 2015
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
12/30261215 DC : 0
|
BS EN 13060 - SMALL STEAM STERILIZERS |
BS EN 16372 : 2014
|
AESTHETIC SURGERY SERVICES |
MEDDEV 2.12-2 : REV 2
|
POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
07/30147572 DC : DRAFT SEP 2007
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
02/563832 DC : DRAFT SEP 2002
|
BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
BS EN ISO 80369-7 : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
UNE EN 1865-1 : 2011
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN 1865-3:2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
UNI EN 1865-4 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
BS PD CEN/TR 16386 : 2013
|
DENTISTRY - GUIDELINES FOR HANDLING METHACRYLATE-BASED MATERIALS IN THE DENTAL LABORATORY |
BS EN ISO 11608-7 : 2017
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
09/30193290 DC : DRAFT MAR 2009
|
BS EN 12183 - MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
PREN 455-3 : DRAFT 2013
|
MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
I.S. EN 61326-2-6:2013
|
ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT (IEC 61326-2-6:2012 (EQV)) |
10/30215054 DC : DRAFT JUNE 2010
|
BS EN 1865-3 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
VDI 5702-1 : 2017
|
MEDICAL DEVICE SOFTWARE - MEDICAL SPICE PROCESS ASSESSMENT MODEL |
11/30252448 DC : 0
|
BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
UNE EN ISO 80369-7 : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
DIN EN 15908 E : 2011
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
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 |
VDI 4003 : 2007
|
RELIABILITY MANAGEMENT |
BS EN 15908 : 2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
16/30339543 DC : 0
|
BS EN 62820-3-2 ED 1.0 - BUILDING INTERCOM SYSTEMS - PART 3-2: APPLICATION GUIDELINES - ADVANCED SECURITY BUILDING INTERCOM |
VDI 5700-1 : 2015
|
REPROCESSING HAZARDS - RISK MANAGEMENT IN REPROCESSING OF MEDICAL DEVICES - MEASURES FOR RISK CONTROL |
08/30184612 DC : DRAFT SEP 2008
|
BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
VDI 4007 : 2012
|
RELIABILITY GOALS - DETERMINATION, CHECK, REVIEW, CERTIFICATE |
MEDDEV 2.7-4 : REV 1
|
GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES |
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 |
I.S. EN 61010-2-040:2015
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS |
09/30201992 DC : 0
|
BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
DIN EN 16442 E : 2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
04/30057165 DC : 0
|
BS EN 14931 - PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBERS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
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) |
UNE EN 15908 : 2011
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
PREN 14180 : DRAFT 2012
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
DIN EN 1865-4 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
DIN EN ISO 11608-7 E : 2017
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
BS EN 80601-2-35 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
UNI CEI EN 1041 : 2013
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
BS EN ISO 5361 : 2016
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO 5361:2016) |
VDI 5703 : 2015
|
SYSTEMATICAL DEVELOPMENT FOR A MODEL-BASED TESTING OF MEDICAL DEVICES |
15/30278530 DC : 0
|
BS ISO 18562-1 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
DD CEN/TS 14507-2 : 2003
|
INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
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) |
13/30281504 DC : 0
|
BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
14/30270614 DC : 0
|
BS EN 14065 - TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
BS EN ISO 15798 : 2013
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES |
13/30278676 DC : 0
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
DIN EN ISO 13958 : 2016
|
CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
I.S. EN 60601-1-10:2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
15/30278540 DC : 0
|
BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
04/30107372 DC : DRAFT AUG 2004
|
BS EN 12183 - MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
15/30278534 DC : 0
|
BS ISO 18562-2 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 2: TESTS FOR EMISSIONS OF PARTICULATE MATTER |
BS EN ISO 11073-00103 : 2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
18/30349834 DC : 0
|
BS ISO 21802 - ASSISTIVE PRODUCTS - GUIDELINES ON COGNITIVE ACCESSIBILITY - DAILY TIME MANAGEMENT |
BS EN 60601-1-2 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS |
BS EN 1865-4 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
DIN EN 1865-3 : 2015
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
08/30184615 DC : DRAFT SEP 2008
|
BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
UNE EN 16372 : 2015
|
AESTHETIC SURGERY SERVICES |
BS EN 62570 : 2015
|
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
13/30276231 DC : 0
|
BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
BS EN 45502-2-3 : 2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
BS ISO 15001 : 2003 AMD 15145
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - COMPATIBILITY WITH OXYGEN |
BS EN 61326-2-6 : 2013
|
ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
02/563808 DC : DRAFT SEP 2002
|
BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
02/563845 DC : DRAFT SEP 2002
|
BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
05/30128373 DC : DRAFT JAN 2005
|
ISO 7396-2 - MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS - BASIC REQUIREMENTS |
PREN 285 : DRAFT 2013
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
BS EN 14931 : 2006
|
PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
BS EN 62366-1 : 2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
07/30169858 DC : 0
|
BS EN 1865-1 - SPECIFICATIONS FOR PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
11/30237926 DC : 0
|
BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
UNE EN 1865-4 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
03/317861 DC : DRAFT OCT 2003
|
EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
12/30254927 DC : 0
|
BS EN 16372 - AESTHETIC SURGERY SERVICES |
I.S. EN 16844:2017+A2:2019
|
Aesthetic medicine services - Non-surgical medical treatments |
CEI EN 80369-5 : 1ED 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
BS EN 61010-2-040 : 2015
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS |
CEI EN 60601-1-2 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
04/30107378 DC : DRAFT JUL 2004
|
EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
BS EN 62353 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT |
I.S. EN 14931:2006
|
PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
CEI EN 61010-2-101 : 2003
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
06/30122245 DC : 0
|
EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
02/563818 DC : DRAFT SEP 2002
|
BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
UNE EN 60601-1-6 : 2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
BS EN 60601-1-10 : 2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
I.S. CEN TS 15260:2006
|
HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS |
UNE EN 80369-5 : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
I.S. EN 12183:2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
SR CEN/CLC TR 14060:2014
|
MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI) |
PREN 12183 : DRAFT 2004
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
BS EN 62366 : 2008
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
BS PD CR 12401 : 2003
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
DD CEN/TS 15260 : 2006
|
HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS |
DIN EN ISO 80369-7 E : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
I.S. EN 61010-2-101:2017
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
I.S. CEN TS 15277:2006
|
NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
PREN 13060 : DRAFT 2012
|
SMALL STEAM STERILIZERS |
I.S. EN 62366-1:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
DIN EN 14931 : 2006
|
PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTIPLE-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
DIN EN ISO 80369-7 : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
17/30364306 DC : 0
|
BS EN 17180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
DIN EN 16442 : 2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
15/30278537 DC : 0
|
BS ISO 18562-3 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 3: TESTS FOR EMISSIONS OF VOLATILE ORGANIC COMPOUNDS (VOCS) |
I.S. EN ISO 80369-7:2017 COR 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01) |
SR CWA 16697:2013
|
CAR-ADAPTATIONS FOR DISABLED DRIVERS - REQUIREMENTS, TEST METHODS AND BEST PRACTISE GUIDELINES |
UNE EN ISO 16671 : 2016
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
UNE EN ISO 7198 : 2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
EN ISO 16671 : 2015 AMD 1 2017
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017) |
BS EN 1865-2 : 2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
AAMI ISO 14155-2 : 2003
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
I.S. EN 62366-1:2015&AC:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
I.S. EN 60601-1-6:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
BS EN ISO 13408-1 : 2015
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS |
I.S. EN 62570:2015
|
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
CEI EN 61326-2-6 : 2014
|
ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - EMC REQUIREMENTS - PART 2-6: PARTICULAR REQUIREMENTS - IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
I.S. EN ISO 7198:2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
IEEE 11073-00103 : 2012
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
I.S. EN 1865-4:2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
BS EN 1865-1 : 2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN ISO 15798:2013
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
SR CEN/TR 16386:2013
|
DENTISTRY - GUIDELINES FOR HANDLING METHACRYLATE-BASED MATERIALS IN THE DENTAL LABORATORY |
UNE EN 16442 : 2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
EN 13060 : 2014
|
SMALL STEAM STERILIZERS |
I.S. EN 62366-1:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
EN 80601-2-35 : 2009 AMD 1 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016) |
I.S. EN 16372:2014
|
AESTHETIC SURGERY SERVICES |
SR CEN/TR 12401:2009
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
MEDDEV 2.7-1 : REV 4
|
CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC |
BS EN 60601-1-6 : 2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
CEI EN 62570 : 2016
|
STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT |
I.S. EN 45502-2-3:2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
BS EN 62304 : 2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
I.S. EN ISO 11608-7:2017
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
I.S. EN ISO 26722:2015
|
WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014) |
CEI UNI EN 1041 : 2014
|
INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
BS EN 12183 : 2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
PREN 14065 : DRAFT 2014
|
TEXTILES - LAUNDRY PROCESSED TEXTILES - BIOCONTAMINATION CONTROL SYSTEM |
I.S. EN 13060:2014
|
SMALL STEAM STERILIZERS |
DIN EN 12183 : 2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
UNI EN 12183 : 2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
I.S. EN 80601-2-35:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
DIN EN 12183 E : 2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
EN ISO 15798 : 2013 AMD 1 2017
|
OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
ISO 16671 : 2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
UNE EN 12183 : 2014
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
PREN 12184 : DRAFT 2011
|
ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
CEN/CLC/TR 14060 : 2014
|
MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI) |
NF EN 45502-2-3 : 2010
|
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
UNE EN 1865-2 : 2011
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
DIN EN ISO 11608-7 : 2015
|
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
UNE EN 1865-3 : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER |
UNI CEI EN 980 : 2009
|
SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
I.S. EN ISO 15223-1:2016&LC:2016
|
MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
I.S. EN 16442:2015
|
CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES |
I.S. EN 1865-2:2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
BS EN 16844 : 2017
|
AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
ASTM E 2363 : 2014 : REDLINE
|
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
08/30184608 DC : DRAFT SEP 2008
|
BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
BS EN 61010-2-101 : 2017
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 2-101: PARTICULAR REQUIREMENTS FOR IN VITRO DIAGNOSTIC (IVD) MEDICAL EQUIPMENT |
09/30193293 DC : DRAFT MAR 2009
|
BS EN 12184 - ELECTRICALLY POWERED WHEELCHAIRS, SCOOTERS AND THEIR CHARGERS - REQUIREMENTS AND TEST METHODS |
06/30123163 DC : 0
|
BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
DIN EN 14931 E : 2006
|
PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING |
DIN EN 80369-5 : 2017
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
DIN EN 1865-2 E : 2015
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER |
I.S. EN 1865-1:2010
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT |
I.S. EN 15908:2010
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NON-INTERCHANGEABLE SCREW-THREADED (NIST) LOW-PRESSURE CONNECTORS FOR MEDICAL GASES |
I.S. EN 80369-5:2016
|
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
PREN 12182 : 2009-06
|
ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
DIN EN 1865-4 E : 2012
|
PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR |
MEDDEV 2.12-1 : REV 8
|
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
BS EN ISO 16671 : 2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
EN 16844 : 2017
|
AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
EN 12183 : 2009-09
|
MANUAL WHEELCHAIRS - REQUIREMENTS AND TEST METHODS |
I.S. EN 62366:2009
|
MEDICAL DEVICES - 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) |
I.S. CEN/TS 14507-2:2003
|
INHALATIONAL NITRIC OXIDE SYSTEMS - PART 2: SUPPLY SYSTEMS |
I.S. EN 60601-1-2:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
I.S. EN ISO 16671:2015
|
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |