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ISO/TC 194  - Biological evaluation of medical devices

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Standards and projects under the direct responsibility of ISO/TC 194 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO 10993-1:2009
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
60.60 11.100.20ISO/TC 194
ISO 10993-1:2009/Cor 1:2010
60.60 11.100.20ISO/TC 194
ISO 10993-2:2006
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
90.93 11.100.20ISO/TC 194
ISO 10993-3:2003
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.92 11.100.20ISO/TC 194
ISO 10993-4:2002
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
90.92 11.100.20ISO/TC 194
ISO 10993-4:2002/Amd 1:2006
60.60 11.100.20ISO/TC 194
ISO 10993-5:2009
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
90.92 11.100.20ISO/TC 194
ISO 10993-6:2007
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
90.92 11.100.20ISO/TC 194
ISO 10993-7:2008
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
90.92 11.100.20ISO/TC 194
ISO 10993-7:2008/Cor 1:2009
60.60 11.100.20ISO/TC 194
ISO 10993-9:2009
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
90.92 11.100.20ISO/TC 194
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
60.60 11.100.20ISO/TC 194
ISO 10993-11:2006
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
90.93 11.100.20ISO/TC 194
ISO 10993-12:2012
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
60.60 11.100.20ISO/TC 194
ISO 10993-13:2010
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
90.92 11.100.20ISO/TC 194
ISO 10993-14:2001
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
90.93 11.100.20ISO/TC 194
ISO 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
90.93 11.100.20ISO/TC 194
ISO 10993-16:2010
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
90.92 11.100.20ISO/TC 194
ISO 10993-17:2002
Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
90.92 11.100.20ISO/TC 194
ISO 10993-18:2005
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
90.92 11.100.20ISO/TC 194
ISO/TS 10993-19:2006
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
90.92 11.100.20ISO/TC 194
ISO/TS 10993-20:2006
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
90.60 11.100.20ISO/TC 194
ISO 13022:2012
Medical products containing viable human cells -- Application of risk management and requirements for processing practices
60.60 11.100.20ISO/TC 194/SC 1
ISO 14155:2011
Clinical investigation of medical devices for human subjects -- Good clinical practice
60.60 11.100.20ISO/TC 194
ISO 14155:2011/Cor 1:2011
60.60 11.100.20ISO/TC 194
ISO/TR 15499:2012
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
60.60 11.100.20ISO/TC 194
ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
90.93 11.100.20ISO/TC 194/SC 1
ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
90.60 11.100.20ISO/TC 194/SC 1
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
90.93 11.100.20ISO/TC 194/SC 1
ISO/TR 22442-4:2010
Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
60.60 11.100.20ISO/TC 194/SC 1