Subcommittee Subcommittee Title Published standards Standards under development
ISO/TC 194/SC 1 Tissue product safety 5 2
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Standard and/or project under the direct responsibility of ISO/TC 194 Secretariat Stage ICS
ISO 10993-1:1992
Biological evaluation of medical devices -- Part 1: Guidance on selection of tests
95.99
95.99
ISO 10993-1:1997
Biological evaluation of medical devices -- Part 1: Evaluation and testing
95.99
ISO 10993-1:2003
Biological evaluation of medical devices -- Part 1: Evaluation and testing
95.99
ISO 10993-1:2009
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
95.99
95.99
ISO 10993-1:2018
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
60.60
ISO 10993-2:1992
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
95.99
ISO 10993-2:2006
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
90.92
ISO/CD 10993-2
Biological evaluation of medical devices -- Part 2: Animal welfare requirements
30.20
ISO 10993-3:1992
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99
ISO 10993-3:2003
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99
ISO 10993-3:2014
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.20
ISO 10993-4:1992
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
95.99
ISO 10993-4:2002
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
95.99
95.99
ISO 10993-4:2017
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
60.60
ISO 10993-5:1992
Biological evaluation of medical devices -- Part 5: Tests for cytotoxicity: in vitro methods
95.99
ISO 10993-5:1999
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
95.99
ISO 10993-5:2009
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
90.93
ISO 10993-6:1994
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
95.99
ISO 10993-6:2007
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
95.99
ISO 10993-6:2016
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
60.60
ISO 10993-7:1995
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
95.99
ISO 10993-7:2008
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
90.93
60.60
50.20
ISO 10993-8:2000
Biological evaluation of medical devices -- Part 8: Selection and qualification of reference materials for biological tests
95.99
ISO 10993-9:1999
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
95.99
ISO 10993-9:2009
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
90.92
ISO/FDIS 10993-9
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
50.60
ISO/TR 10993-9:1994
Biological evaluation of medical devices -- Part 9: Degradation of materials related to biological testing
95.99
ISO 10993-10:1995
Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization
95.99
ISO 10993-10:2002
Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity
95.99
95.99
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
90.92
ISO/CD 10993-10
Biological evaluation of medical devices -- Part 10: Tests for skin sensitization
30.20
ISO 10993-11:1993
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
95.99
ISO 10993-11:2006
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
95.99
ISO 10993-11:2017
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
60.60
ISO 10993-12:1996
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
95.99
ISO 10993-12:2002
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
95.99
ISO 10993-12:2007
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
95.99
ISO 10993-12:2012
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
90.92
ISO/DIS 10993-12
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
40.60
ISO 10993-13:1998
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
95.99
ISO 10993-13:2010
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
90.93
ISO 10993-14:2001
Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics
90.93
ISO 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
90.92
ISO/FDIS 10993-15
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
50.60
ISO 10993-16:1997
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
95.99
ISO 10993-16:2010
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
95.99
ISO 10993-16:2017
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
60.60
ISO 10993-17:2002
Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
90.92
ISO/AWI 10993-17
Biological evaluation of medical devices -- Part 17: Toxicological risk assessment of medical device constituents
20.00
ISO 10993-18:2005
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
90.92
ISO/FDIS 10993-18
Biological evaluation of medical devices -- Part 18: Chemical characterization of medical device materials within a risk management process
50.60
ISO/DTS 10993-19
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
30.99
ISO/TS 10993-19:2006
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
90.92
ISO/TS 10993-20:2006
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
90.92
ISO/TR 10993-22:2017
Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials
60.60
ISO/DIS 10993-23
Biological evaluation of medical devices -- Part 23: Tests for irritation
40.60
ISO/TR 10993-33:2015
Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO 10993-3
60.60
ISO/NP TR 10993-55
Biological evaluation of medical devices -- Part 55: Round Robin on cytotoxicity
10.99
ISO 14155:1996
Clinical investigation of medical devices
95.99
ISO 14155:2011
Clinical investigation of medical devices for human subjects -- Good clinical practice
90.92
60.60
ISO/DIS 14155
Clinical investigation of medical devices for human subjects -- Good clinical practice
40.60
ISO 14155-1:2003
Clinical investigation of medical devices for human subjects -- Part 1: General requirements
95.99
ISO 14155-2:2003
Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
95.99
ISO/TR 15499:2012
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
95.99
ISO/TR 15499:2016
Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process
95.99
ISO/TS 20993:2006
Biological evaluation of medical devices -- Guidance on a risk-management process
95.99
ISO/DTR 21582
Pyrogenicity -- Principle and method for pyrogen testing of medical devices
30.60
ISO/TS 21726:2019
Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
60.60
ISO/TR 37137:2014
Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants
90.92
ISO/DTS 37137-1
Biological evaluation of medical devices -- Part 1: Guidance for absorbable implants
30.60
ISO/DTR 37137-2
Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants -- Part 2: Standard guide for absorbable metals
30.60

No matching records found