EN ISO 10993-5:2009
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Amended by
Published date
01-06-2009
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ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices.These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
| Committee |
CEN/TC 206
|
| DevelopmentNote |
Supersedes EN 30993-5. (05/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PN EN ISO 10993-5 : 2009 | Identical |
| NBN EN ISO 10993-5 : 2009 | Identical |
| BS EN ISO 10993-5:2009 | Identical |
| NEN EN ISO 10993-5 : 2009 | Identical |
| NF EN ISO 10993-5 : 2010 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| SS-EN ISO 10993-5:2009 | Identical |
| I.S. EN ISO 10993-5:2009 | Identical |
| ISO 10993-5:2009 | Identical |
| DIN EN ISO 10993-5:2009-10 | Identical |
| DS EN ISO 10993-5 : 2009 | Identical |
| ONORM EN ISO 10993-5 : 2009 | Identical |
| UNE-EN ISO 10993-5:2009 | Identical |
| 15/30278540 DC : 0 | BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| 17/30358658 DC : 0 | BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| 17/30358661 DC : 0 | BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| BS EN 455-3:2015 | Medical gloves for single use Requirements and testing for biological evaluation |
| VDI 5703:2015-09 | Systematical development for a model-based testing of medical devices |
| 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 |
| 13/30281504 DC : 0 | BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| I.S. EN ISO 4074:2015 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
| 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 16820:2015-03 (Draft) | RUBBER AND PLASTICS HOSES AND HOSE ASSEMBLIES FOR USE IN THE PHARMACEUTICAL AND BIOTECHNOLOGICAL INDUSTRY - BONDED ELASTOMERIC HOSES WITH OR WITHOUT A LINING |
| PD CEN/TR 16953:2017 | Medical gloves for single use. Guidance for selection |
| CEN/TR 16953:2017 | Medical gloves for single use - Guidance for selection |
| DIN EN 455-3:2015-07 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| 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) |
| S.R. CEN/TR 16953:2017 | MEDICAL GLOVES FOR SINGLE USE - GUIDANCE FOR SELECTION |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| BS EN 16820:2017 | Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry. Bonded elastomeric hoses with or without a lining |
| PREN 455-3 : DRAFT 2013 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| DIN EN 14683:2014-07 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| BS EN 14683:2014 | Medical face masks. Requirements and test methods |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| 17/30359567 DC : 0 | BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| EN 14683:2014 | Medical face masks - Requirements and test methods |
| I.S. EN 14683:2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| I.S. EN 455-3:2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| ISO 4074:2015 | Natural rubber latex male condoms — Requirements and test methods |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN 16820:2017 | Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN ISO 4074:2015 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| 15/30315105 DC : 0 | BS EN 16820 - HOSE ASSEMBLIES FOR USE IN THE PHARMACEUTICAL AND BIOTECHNOLOGICAL INDUSTRY WITH HOSES OF NON-METALLIC MATERIALS - ELASTOMERIC HOSES WITH OR WITHOUT LINER |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| 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 |
| 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) |
| I.S. EN 16820:2017 | RUBBER AND PLASTICS HOSES AND HOSE ASSEMBLIES FOR USE IN THE PHARMACEUTICAL AND BIOTECHNOLOGICAL INDUSTRY - BONDED ELASTOMERIC HOSES WITH OR WITHOUT A LINING |
| PREN 13795-2 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| BS EN 13503-5:2001 | Ophthalmic implants. Intraocular lenses Biocompatibility |
| 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 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| UNE-EN 16820:2018 | Rubber and plastics hoses and hose assemblies for use in the pharmaceutical and biotechnological industry - Bonded elastomeric hoses with or without a lining |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| UNE-EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| UNE-EN ISO 4074:2016 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
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