TC 194Ε’cΜΆi2019.03j
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| Reference | ||||||
| ISO/DTS 37137-1 | Biological evaluation of medical devices -- Part 1: Guidance for absorbable implants | ISO/TC 194/WG 2 | 2017-08-07 | 2018-10-13 | 30.60 | @ |
| ISO/DTR 37137-2 | Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants -- Part 2: Standard guide for absorbable metals | ISO/TC 194/WG 2 | 2016-03-08 | 2016-07-11 | 30.60 | @ |
| ISO/FDIS 10993-15 | Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | ISO/TC 194/WG 2 | 2014-12-09 | 2019-03-06 | 50.00 | |
| ISO/FDIS 10993-9 | Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | ISO/TC 194/WG 2 | 2014-12-09 | 2019-03-06 | 50.00 | @ |
| ISO/DIS 14155 | Clinical investigation of medical devices for human subjects -- Good clinical practice | ISO/TC 194/WG 4 | 2016-06-17 | 2018-09-13 | 40.60 | @ |
| ISO/NP TR 10993-55 | Round robin on cytotoxicity -- Part 55: Title missing | ISO/TC 194/WG 5 | 2016-10-05 | 2016-10-05 | 10.99 | @ |
| ISO/NP TS 10993-20 | Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices | ISO/TC 194/WG 7 | 2014-12-09 | 2014-12-09 | 10.99 | @ |
| ISO/DIS 10993-23 | Biological evaluation of medical devices -- Part 23: Determination of skin irritation of medical device extracts using Reconstructed human Epidermis (RhE) | ISO/TC 194/WG 8 | 2018-01-18 | 2019-03-06 | 40.00 | |
| ISO/AWI 10993-10 | Biological evaluation of medical devices -- Part 10: Tests for skin sensitization | ISO/TC 194/WG 8 | 2018-01-15 | 2018-01-15 | 20.00 | |
| ISO/AWI 10993-17 | Biological evaluation of medical devices -- Part 17: Toxicological risk assessment of medical device constituents | ISO/TC 194/WG 11 | 2018-01-22 | 2018-06-06 | 20.00 | @ |
| ISO 10993-7:2008/DAmd1 | Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals--Amendment 1 | ISO/TC 194/WG 11 | 2018-06-07 | 2018-11-02 | 40.60 | |
| ISO/DIS 10993-12 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | ISO/TC 194/WG 12 | 2018-01-21 | 2019-03-06 | 40.00 | |
| ISO/FDIS 10993-18 | Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | ISO/TC 194/WG 14 | 2015-05-08 | 2019-03-06 | 50.00 | |
| ISO/PRF TR 10993-19 | Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials | ISO/TC 194/WG 14 | 2018-01-19 | 2019-03-06 | 30.60 | |
| ISO/DTR 21582 | Pyrogenicity -- Principle and method for pyrogen testing of medical devices | ISO/TC 194/WG 16 | 2016-03-11 | 2016-07-11 | 30.60 | |
| ISO/DIS 22442-1 | Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management | ISO/TC 194/SC 1/WG 1 | 2017-07-18 | 2018-11-02 | 40.60 | |
| ISO/DIS 22442-2 | Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling | ISO/TC 194/SC 1/WG 2 | 2017-07-10 | 2019-02-15 | 40.60 | |
| ISO/TS 21726:2019 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | ISO/TC 194/WG 1 | 2018-08-17 | 60.60 | 2018-08 | |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents | ISO/TC 194/WG 11 | 2019-02-01 | 60.60 | 2019-01 | |
| ISO 10993-11:2017 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | ISO/TC 194/WG 7 | 2017-09-14 | 60.60 | 2017-09 | |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials | ISO/TC 194/WG 17 | 2017-07-14 | 60.60 | 2017-07 | |
| ISO 10993-16:2017 | Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables | ISO/TC 194/WG 13 | 2017-05-16 | 60.60 | 2017-05 | |
| ISO 10993-4:2017 | Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood | ISO/TC 194/WG 9 | 2017-04-12 | 60.60 | 2017-04 | |
| ISO 10993-6:2016 | Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | ISO/TC 194/WG 10 | 2016-11-28 | 60.60 | 2016-12 | |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management | ISO/TC 194/SC 1 | @ | 2017-07-18 | 90.92 | 2015-11 |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling | ISO/TC 194/SC 1 | 2017-07-10 | 90.92 | 2015-11 | |
| ISO/TR 10993-33:2015 | Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO 10993-3 | ISO/TC 194/WG 6 | 2015-03-06 | 60.60 | 2015-03 | |
| ISO 10993-3:2014 | Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | ISO/TC 194/WG 6 | 2014-09-24 | 60.60 | 2014-10 | |
| ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants | ISO/TC 194 | 2016-04-07 | 90.92 | 2014-05 | |
| ISO 10993-12:2012 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | ISO/TC 194/WG 12 | @ | 2017-09-06 | 90.60 | 2012-07 |
| ISO 13022:2012 | Medical products containing viable human cells -- Application of risk management and requirements for processing practices | ISO/TC 194/SC 1 | 2017-06-07 | 90.93 | 2012-04 | |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects -- Good clinical practice | ISO/TC 194/WG 4 | @ | 2016-06-17 | 90.92 | 2011-02 |
| 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 | ISO/TC 194/SC 1 | 2016-04-22 | 90.93 | 2010-12 | |
| ISO 10993-10:2010 | Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | ISO/TC 194/WG 8 | 2018-01-12 | 90.92 | 2010-08 | |
| ISO 10993-13:2010 | Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices | ISO/TC 194/WG 2 | @ | 2013-07-09 | 90.93 | 2010-06 |
| ISO 10993-9:2009 | Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | ISO/TC 194/WG 2 | 2013-07-09 | 90.93 | 2009-12 | |
| ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | ISO/TC 194/WG 5 | @ | 2017-02-09 | 90.93 | 2009-06 |
| ISO 10993-7:2008 | Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | ISO/TC 194/WG 11 | 2016-11-28 | 90.93 | 2008-10 | |
| 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 | ISO/TC 194/SC 1 | 2015-09-17 | 90.93 | 2007-12 | |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices | ISO/TC 194/WG 7 | 2014-10-10 | 90.92 | 2006-08 | |
| ISO 10993-2:2006 | Biological evaluation of medical devices -- Part 2: Animal welfare requirements | ISO/TC 194/WG 3 | 2015-06-17 | 90.60 | 2006-07 | |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials | ISO/TC 194/WG 14 | @ | 2017-01-11 | 90.93 | 2006-06 |
| ISO 10993-18:2005 | Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | ISO/TC 194/WG 14 | 2013-07-31 | 90.93 | 2005-07 | |
| ISO 10993-17:2002 | Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances | ISO/TC 194/WG 11 | 2018-01-19 | 90.92 | 2002-12 | |
| ISO 10993-14:2001 | Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | ISO/TC 194/WG 2 | @ | 2013-08-05 | 90.93 | 2001-11 |
| ISO 10993-15:2000 | Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | ISO/TC 194/WG 2 | 2014-10-10 | 90.92 | 2000-12 |