EN ISO 10993-1:2009/AC:2010
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
Amendment of
Superseded date
25-03-2022
Published date
06-03-2010
Publisher
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
of medical devices
5 Categorization of medical devices
6 Biological evaluation process
7 Interpretation of biological evaluation data and overall
biological safety assessment
Annex A (informative) - Biological evaluation tests
Annex B (informative) - Guidance on the risk management process
Annex C (informative) - Suggested procedure for literature review
Bibliography
Annex ZA (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this International
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyse the biological safety of the medical device; - the assessment of the biological safety of the medical device.
| Committee |
TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM EN ISO 10993-1 : 2011 | Identical |
| SN EN ISO 10993-1 : 2010 CORR 2010 | Identical |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| UNI EN ISO 10993-1 : 2010 | Identical |
| NEN EN ISO 10993-1 : 2009 C1 2010 | Identical |
| I.S. EN ISO 10993-1:2009+AC:2010 | Identical |
| PN EN ISO 10993-1 : 2010 AC 2010 | Identical |
| ISO 10993-1:2009 | Identical |
| NBN EN ISO 10993-1 : 2009 COR 2010 | Identical |
| ISO 10993-1:2018 | Identical |
| UNE-EN ISO 10993-1:2010 | Identical |
| DIN EN ISO 10993-1:2010-04 | Identical |
| NF EN ISO 10993-1 : 2010 | Identical |
| I.S. EN ISO 5364:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016) |
| I.S. EN 12180:2000 | NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS |
| I.S. EN 15424:2007 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN 13824:2005 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| I.S. EN 12022:1999 | BLOOD GAS EXCHANGERS |
| I.S. EN 13503-8:2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| 08/30184612 DC : DRAFT SEP 2008 | BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| 15/30278540 DC : 0 | BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
| 02/563845 DC : DRAFT SEP 2002 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| DIN EN ISO 7199:2015-06 (Draft) | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| BS EN 868-9:2009 | Packaging for terminally sterilized medical devices Uncoated nonwoven materials of polyolefines. Requirements and test methods |
| DIN EN 868-10:2009-09 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| 17/30360918 DC : 0 | BS EN 868-9 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| 17/30358658 DC : 0 | BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| DIN EN 868-10 E : 2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| 17/30358661 DC : 0 | BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| 17/30360912 DC : 0 | BS EN 868-10 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| UNI EN 14683 : 2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 22442-1:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| DIN EN 1642:2012-06 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 867-5:2001 | Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
| BS EN 455-3:2015 | Medical gloves for single use Requirements and testing for biological evaluation |
| BS EN 15424:2007 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| UNE-EN ISO 16672:2016 | Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
| BS EN 13824:2004 | Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements |
| DIN EN 1733:2003-02 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| DIN EN 12470-3:2000-04 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| EN 1282-2:2005+A1:2009 | Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| EN 13503-8 : 2000 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
| EN ISO 5364:2016 | Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016) |
| EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
| EN 12022 : 1999 | BLOOD GAS EXCHANGERS |
| DIN EN ISO 21649:2010-01 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| DIN EN 15424:2007-08 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| EN 12470-3:2000+A1:2009 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
| EN 12180 : 2000 | NON-ACTIVE SURGICAL IMPLANTS - BODY CONTOURING IMPLANTS - SPECIFIC REQUIREMENTS FOR MAMMARY IMPLANTS |
| EN 12470-2:2000+A1:2009 | Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
| VDI 5703:2015-09 | Systematical development for a model-based testing of medical devices |
| VDI 5700 Blatt 1:2015-04 | Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
| I.S. EN 12470-5:2003 | CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE) |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| PREN 14683 : DRAFT 2017 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| PREN 13795-1 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| 07/30167336 DC : DRAFT AUG 2007 | BS EN 868-10 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES FOR USE IN THE MANUFACTURE OF SEALABLE POUCHES, REELS AND LIDS - REQUIREMENTS AND TEST METHODS |
| BS EN ISO 8536-13:2016 | Infusion equipment for medical use Graduated flow regulators for single use with fluid contact |
| 14/30303657 DC : 0 | BS EN ISO 1135-3 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SET FOR SINGLE USE |
| 05/30066638 DC : DRAFT OCT 2005 | EN 15424 - STERILIZATION OF MEDICAL DEVICES - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF STERILIZATION PROCESSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE |
| BS EN ISO 7199:2017 | Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) |
| 13/30281504 DC : 0 | BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| BS EN 45502-2-3:2010 | Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
| I.S. EN ISO 8536-13:2016 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016) |
| PREN 12182 : 2009-06 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| UNI EN 868-9 : 2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| DIN EN 14683 E : 2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| BS EN 868-10:2009 | Packaging for terminally sterilized medical devices Adhesive coated nonwoven materials of polyolefines. Requirements and test methods |
| DIN EN 1641:2010-02 | Dentistry - Medical devices for dentistry - Materials |
| DIN EN ISO 1135-4:2016-06 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
| DIN EN 12470-2:2009-11 | Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009) |
| BS EN ISO 7864:2016 | Sterile hypodermic needles for single use. Requirements and test methods |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| BS EN ISO 10993-6:2016 | Biological evaluation of medical devices Tests for local effects after implantation |
| BS EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Application of risk management |
| BS EN 340:2003 | Protective clothing. General requirements |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| BS EN 12470-3 : 2000 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| I.S. EN ISO 10993-6:2016 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016) |
| I.S. EN ISO 1135-4:2015 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| DIN EN 12470-5:2003-09 | CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE) |
| DIN EN 12470-4:2001-02 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 8537:2016 | STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
| I.S. EN ISO 22442-1:2015 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
| I.S. EN 1642:2011 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| I.S. EN ISO 4074:2015 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
| I.S. EN ISO 14727:1999 | DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| I.S. EN 1641:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| I.S. EN 12470-2:2000 | CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| I.S. EN 1282-2:2005 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| I.S. EN ISO 7864:2016 | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014) |
| I.S. EN ISO 16672:2015 | OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015) |
| UNI EN 1642 : 2012 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| VDI 5700 Blatt 2:2017-06 | Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings |
| VDI 3823 Blatt 4:2006-11 | Vacuum coating quality assurance - Testing of vacuum coated plastics |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| DIN EN ISO 7199 E : 2017 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| PREN 868-10 : DRAFT 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| BS EN ISO 5364:2016 | Anaesthetic and respiratory equipment. Oropharyngeal airways |
| 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 |
| 09/30201992 DC : 0 | BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| 08/30184615 DC : DRAFT SEP 2008 | BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS |
| 01/560291 DC : DRAFT JAN 2001 | BS EN ISO 17510-2 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
| 03/317861 DC : DRAFT OCT 2003 | EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| UNI EN 868-10 : 2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 11199-1:1999 | WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 1: WALKING FRAMES |
| DIN EN 14683:2014-07 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 5361:2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014) |
| EN ISO 16671:2015/A1:2017 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017) |
| 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 |
| I.S. EN ISO 16671:2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015) |
| DIN EN 12470-3:2009-11 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| DIN EN 12470-4:2009-11 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| DIN EN 455-3:2015-07 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| BS EN 12022:1999 | Blood-gas exchangers |
| BS EN ISO 21649:2009 | Needle-free injectors for medical use. Requirements and test methods |
| ISO 5364:2016 | Anaesthetic and respiratory equipment — Oropharyngeal airways |
| BS EN 12470-5:2003 | Clinical thermometers Performance of infra-red ear thermometers (with maximum device) |
| BS EN 12006-1:1999 | Non-active surgical implants. Particular requirements for cardiac and vascular implants Heart valve substitutes |
| ISO 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| EN 868-10:2009 | Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods |
| I.S. EN 868-10:2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| UNE-EN 1282-2:2006 | Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
| EN 868-9:2009 | Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods |
| EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
| UNI EN 12470-4 : 2009 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| UNI EN 1641 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| UNI EN 12470-3 : 2009 | CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI EN 12470-2 : 2009 | CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS |
| UNI EN 1282-2 : 2009 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| UNI CEI EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 25424:2011-09 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| I.S. EN 1733:2002 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 02/563832 DC : DRAFT SEP 2002 | BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS |
| PREN 455-3 : DRAFT 2013 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| UNE-EN ISO 8536-13:2017 | Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016) |
| 02/564996 DC : DRAFT NOV 2002 | BS EN ISO 16201 - TECHNICAL AIDS FOR DISABLED PERSONS - REMOTE CONTROL SYSTEMS |
| 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 |
| 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 |
| 00/560097 DC : DRAFT JAN 2000 | BS EN 13824 - STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ASEPTIC PROCESSES - REQUIREMENTS AND GUIDANCE |
| BS EN ISO 5361:2016 | Anaesthetic and respiratory equipment. Tracheal tubes and connectors |
| 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 |
| EN ISO 11199-1:1999 | WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 1: WALKING FRAMES |
| 16/30346835 DC : 0 | BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS |
| 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) |
| BS EN 14683:2014 | Medical face masks. Requirements and test methods |
| I.S. EN ISO 15798:2013 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013) |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| PREN 868-9 : DRAFT 2017 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| ISO 16671:2015 | Ophthalmic implants — Irrigating solutions for ophthalmic surgery |
| 17/30359567 DC : 0 | BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| EN 14683:2014 | Medical face masks - Requirements and test methods |
| BS EN ISO 16671 : 2015 | OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY |
| I.S. EN 14683:2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 21649 E : 2010 | NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| UNE-EN ISO 1135-4:2016 | Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015) |
| UNE-EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| ISO 14727:1998 | Dental implants Prefabricated parts connecting suprastructures to dental implants Contents of technical file |
| BS EN 12011:1998 | Instrumentation to be used in association with non-active surgical implants. General requirements |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| BS EN ISO 11199-1:1999 | Walking aids manipulated by both arms. Requirements and test methods Walking frames |
| UNE-EN ISO 4074:2016 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| ISO 8536-13:2016 | Infusion equipment for medical use Part 13: Graduated flow regulators for single use with fluid contact |
| BS EN ISO 14727:1999 | Dental implants. Prefabricated parts connecting suprastructures to dental implants. Contents of technical file |
| ISO 1135-4:2015 | Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed |
| UNE-EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| BS EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| BS EN ISO 11334-4:1999 | Walking aids manipulated by one arm. Requirements and test methods Walking sticks with three or more legs |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| BS EN 12470-4 : 2001 | CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT |
| ISO 16672:2015 | Ophthalmic implants Ocular endotamponades |
| UNE-EN 1642:2012 | Dentistry - Medical devices for dentistry - Dental implants |
| BS EN 13503-8:2000 | Ophthalmic implants. Intraocular lenses Fundamental requirements |
| I.S. EN 455-3:2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| ISO 5361:2016 | Anaesthetic and respiratory equipment — Tracheal tubes and connectors |
| BS EN 12470-2 : 2001 | CLINICAL THERMOMETERS - PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS |
| ISO 11334-4:1999 | Walking aids manipulated by one arm Requirements and test methods Part 4: Walking sticks with three or more legs |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| BS EN 1282-2 : 2005 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| ISO 4074:2015 | Natural rubber latex male condoms Requirements and test methods |
| BS EN 12180:2000 | Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants |
| BS EN 12523:1999 | External limb prostheses and external orthoses. Requirements and test methods |
| BS EN 12182:2012 | Assistive products for persons with disability. General requirements and test methods |
| BS EN 1641:2004 | Dentistry. Medical devices for dentistry. Materials |
| EN ISO 8536-13:2016 | Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016) |
| EN ISO 10993-6:2016 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016) |
| EN ISO 11334-4 : 1999 | WALKING AIDS MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - WALKING STICKS WITH THREE OR MORE LEGS |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN ISO 21649:2009 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
| EN ISO 5361:2016 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) |
| EN 1733 : 2002 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN ISO 14727:1998/AC:1998 | DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE |
| EN 1641:2009 | Dentistry - Medical devices for dentistry - Materials |
| EN 45502-2-3:2010 | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| 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) |
| EN 1642:2011 | Dentistry - Medical devices for dentistry - Dental implants |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| EN 12470-4:2000+A1:2009 | Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
| EN 867-5:2001 | Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S |
| EN 340:2003 | Protective clothing - General requirements |
| EN ISO 4074:2015 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| EN 13824 : 2004 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| 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 |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| 02/121895 DC : DRAFT APR 2002 | BS EN 13060 - SMALL STEAM STERILIZERS |
| I.S. EN 340:2004 | PROTECTIVE CLOTHING - GENERAL REQUIREMENTS |
| 12/30260949 DC : 0 | BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHOD |
| BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
| 07/30167333 DC : DRAFT AUG 2007 | BS EN 868-9 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES FOR USE IN THE MANUFACTURE OF SEALABLE POUCHES, REELS AND LIDS - REQUIREMENTS AND TEST METHODS |
| DIN EN 868-9:2009-09 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 3826-4:2015 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
| 03/113382 DC : DRAFT SEP 2003 | BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
| UNE-EN ISO 16671:2016 | Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015) |
| PREN 13795-2 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| I.S. EN 45502-2-3:2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| I.S. EN ISO 7199:2017 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| EN ISO 15798:2013/A1:2017 | OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017) |
| 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) |
| I.S. EN 868-9:2009 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS |
| DIN EN ISO 10993-14 E : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
| DIN EN ISO 10993-14:2009-08 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| BS EN 13503-5:2001 | Ophthalmic implants. Intraocular lenses Biocompatibility |
| EN ISO 7199:2017 | Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016) |
| BS EN 1733:2002 | Suction catheters for use in the respiratory tract |
| BS EN 1642:2011 | Dentistry. Medical devices for dentistry. Dental implants |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
| BS EN ISO 4074:2015 | Natural rubber latex male condoms. Requirements and test methods |
| EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| EN 12470-5 : 2003 | CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE) |
| EN ISO 1135-4 : 2015 COR 2016 | TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| EN 12523 : 1999 | EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
| DIN EN 13824:2005-02 | STERILIZATION OF MEDICAL DEVICES - ASEPTIC PROCESSING OF LIQUID MEDICAL DEVICES - REQUIREMENTS |
| EN 12006-1 : 1999 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - HEART VALVE SUBSTITUTES |
| DIN EN 1282-2:2009-12 | TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES |
| EN 13503-5 : 2001 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY |
| DIN EN 340:2004-03 | PROTECTIVE CLOTHING - GENERAL REQUIREMENTS |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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