Standards catalogue

ISO/TC 194

Biological and clinical evaluation of medical devices

Subcommittee Subcommittee Title Published standards Standards under development
ISO/TC 194/SC 1 Tissue product safety 5 0
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Standard and/or project under the direct responsibility of ISO/TC 194 Secretariat Stage ICS
ISO 10993-1:1992 [Withdrawn]
Biological evaluation of medical devices -- Part 1: Guidance on selection of tests
95.99
95.99
ISO 10993-1:1997 [Withdrawn]
Biological evaluation of medical devices -- Part 1: Evaluation and testing
95.99
ISO 10993-1:2003 [Withdrawn]
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
90.92
60.60
ISO/DIS 10993-1 [Under development]
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
40.99
ISO 10993-2:1992 [Withdrawn]
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
90.60
ISO 10993-3:1992 [Withdrawn]
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99
ISO 10993-3:2003 [Withdrawn]
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
60.60
ISO 10993-4:1992 [Withdrawn]
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
95.99
ISO 10993-4:2002 [Withdrawn]
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ISO 10993-5:1992 [Withdrawn]
Biological evaluation of medical devices -- Part 5: Tests for cytotoxicity: in vitro methods
95.99
ISO 10993-5:1999 [Withdrawn]
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/CD 10993-5 [Deleted]
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
30.98
ISO 10993-6:1994 [Withdrawn]
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
95.99
ISO 10993-6:2007 [Withdrawn]
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 [Withdrawn]
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
ISO 10993-7:2008/CD Amd 1 [Under development]
30.99
60.60
ISO/WD 10993-7 [Deleted]
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
20.98
ISO 10993-8:2000 [Withdrawn]
Biological evaluation of medical devices -- Part 8: Selection and qualification of reference materials for biological tests
95.99
ISO 10993-9:1999 [Withdrawn]
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
90.93
ISO/CD 10993-9 [Under development]
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
30.99
ISO/TR 10993-9:1994 [Withdrawn]
Biological evaluation of medical devices -- Part 9: Degradation of materials related to biological testing
95.99
ISO 10993-10:1995 [Withdrawn]
Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization
95.99
ISO 10993-10:2002 [Withdrawn]
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
90.93
ISO 10993-11:1993 [Withdrawn]
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
90.92
ISO/FDIS 10993-11 [Under development]
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
50.20
ISO 10993-12:1996 [Withdrawn]
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
95.99
ISO 10993-12:2002 [Withdrawn]
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
95.99
ISO 10993-12:2007 [Withdrawn]
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
90.20
ISO 10993-13:1998 [Withdrawn]
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/CD 10993-15 [Under development]
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
30.99
ISO 10993-16:1997 [Withdrawn]
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
95.99
ISO 10993-16:2010 [Withdrawn]
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
90.93
ISO 10993-18:2005
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
90.93
ISO/CD 10993-18 [Under development]
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
30.99
ISO/NP TS 10993-19 [Under development]
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
10.99
ISO/TS 10993-19:2006
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
90.93
ISO/NP TS 10993-20 [Under development]
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
10.99
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 [Under development]
Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials
60.00
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 [Under development]
Round robin on cytotoxicity -- Part 55: Title missing
10.99
ISO 14155:1996 [Withdrawn]
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/CD 14155 [Under development]
Clinical investigation of medical devices for human subjects -- Good clinical practice
30.99
ISO 14155-1:2003 [Withdrawn]
Clinical investigation of medical devices for human subjects -- Part 1: General requirements
95.99
ISO 14155-2:2003 [Withdrawn]
Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
95.99
ISO/TR 15499:2012 [Withdrawn]
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
60.60
ISO/TS 20993:2006 [Withdrawn]
Biological evaluation of medical devices -- Guidance on a risk-management process
95.99
ISO/DTR 21582 [Under development]
Pyrogenicity -- Principle and method for pyrogen testing of medical devices
30.60
ISO/NP TS 21726 [Under development]
Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of extractable substances from medical devices
10.99
ISO/AWI TS 29741 [Under development]
Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP)
20.00
ISO/TR 37137:2014
Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants
90.92
ISO/DTR 37137-2 [Under development]
Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants -- Part 2: Standard guide for absorbable metals
30.60

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