TC 194で討議中の文書（2017.03）
| Reference | Document title | Reg. date | Stage date | Crnt stage | Next date | Publication date | Timeframe | VA | Committee |
| ISO/TR 15499:2016 | Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process | 2015-06-16 | 2016-12-13 | 60.60 | 2016-12-13 | ISO/TC 194 | |||
| ISO/DIS 10993-1 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | 2014-12-09 | 2017-02-20 | 40.20
(Start date: 2017-02-20 End date: 2017-05-15) |
2017-05-15 | 2017-02-20 | 36 | ISO lead | ISO/TC 194/WG 1 |
| ISO/CD 10993-9 | Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | 2014-12-09 | 2017-02-03 | 30.20
(Start date: 2017-02-03) |
48 | ISO lead | ISO/TC 194/WG 2 | ||
| ISO 10993-13:2010 | Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices | 2006-05-16 | 2013-07-09 | 90.93 | 2018-07-15 | 2013-07-09 | 48 | ISO lead | ISO/TC 194/WG 2 |
| ISO 10993-14:2001 | Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | 1993-10-11 | 2013-08-05 | 90.93 | 2018-07-15 | 2013-08-05 | ISO lead | ISO/TC 194/WG 2 | |
| ISO/CD 10993-15 | Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | 2014-12-09 | 2017-02-03 | 30.20
(Start date: 2017-02-03) |
48 | ISO lead | ISO/TC 194/WG 2 | ||
| ISO 10993-2:2006 | Biological evaluation of medical devices -- Part 2: Animal welfare requirements | 2001-10-11 | 2015-06-17 | 90.60 | 2015-06-17 | ISO lead | ISO/TC 194/WG 3 | ||
| ISO/CD 14155 | Clinical investigation of medical devices for human subjects -- Good clinical practice | 2016-06-17 | 2017-02-03 | 30.20
(Start date: 2017-02-03) |
36 | ISO lead | ISO/TC 194/WG 4 | ||
| ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | 2001-10-11 | 2017-02-09 | 90.93 | 2017-02-09 | ISO lead | ISO/TC 194/WG 5 | ||
| ISO 10993-3:2014 | Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | 2009-11-04 | 2014-09-24 | 60.60 | 2019-07-15 | 2014-09-24 | 48 | ISO lead | ISO/TC 194/WG 6 |
| ISO/TR 10993-33:2015 | Biological evaluation of medical devices -- Part 33: Guidance on tests to evaluate genotoxicity -- Supplement to ISO 10993-3 | 2013-10-08 | 2015-03-06 | 60.60 | 2015-03-06 | 36 | ISO/TC 194/WG 6 | ||
| ISO/FDIS 10993-11 | Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | 2015-01-22 | 2017-02-22 | 50.00 | 2018-01-22 | 36 | ISO lead | ISO/TC 194/WG 7 | |
| ISO/NP TS 10993-20 | Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices | 2014-12-09 | 2014-12-09 | 10.99 | 2017-12-09 | 36 | ISO/TC 194/WG 7 | ||
| ISO 10993-10:2010 | Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | 2007-02-07 | 2016-04-07 | 90.93 | 2016-04-07 | 36 | ISO lead | ISO/TC 194/WG 8 | |
| ISO 10993-4 | Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood | 2013-09-09 | 2017-01-22 | 60.00 | 2017-04-08 | 48 | ISO lead | ISO/TC 194/WG 9 | |
| ISO 10993-6:2016 | Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | 2012-03-05 | 2016-11-28 | 60.60 | 2016-11-28 | Extended | ISO lead | ISO/TC 194/WG 10 | |
| ISO 10993-7:2008 | Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | 2004-02-17 | 2016-11-28 | 90.93 | 2016-11-28 | 36 | ISO lead | ISO/TC 194/WG 11 | |
| ISO 10993-7:2008/CD Amd 1 | Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Amendment 1 | 2016-11-28 | 2016-11-28 | 30.99 | 2018-11-28 | 36 | ISO lead | ISO/TC 194/WG 11 | |
| ISO 10993-17:2002 | Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances | 1994-07-15 | 2016-07-05 | 90.93 | 2016-07-05 | ISO lead | ISO/TC 194/WG 11 | ||
| ISO/AWI TS 29741 | Biological evaluation of medical devices -- Development of tolerable intake values for Di(2-ethylhexyl)phthalate (DEHP) | 2013-08-06 | 2014-04-28 | 20.00 | 2017-08-06 | 48 | ISO/TC 194/WG 11 | ||
| ISO/NP TS 21726 | Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of extractable substances from medical devices | 2016-08-25 | 2016-08-25 | 10.99 | 2019-08-25 | 36 | ISO/TC 194/WG 11 | ||
| ISO 10993-12:2012 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | 2008-12-11 | 2012-06-29 | 60.60 | 2017-04-15 | 2012-06-29 | 36 | ISO lead | ISO/TC 194/WG 12 |
| ISO 10993-16 | Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables | 2015-05-08 | 2017-03-15 | 60.00 | 2017-04-10 | 36 | ISO lead | ISO/TC 194/WG 13 | |
| ISO/CD 10993-18 | Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | 2015-05-08 | 2017-03-17 | 30.20
(Start date: 2017-03-17) |
48 | ISO lead | ISO/TC 194/WG 14 | ||
| ISO/NP TS 10993-19 | Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials | 2014-12-09 | 2014-12-09 | 10.99 | 2017-12-09 | 36 | ISO/TC 194/WG 14 | ||
| ISO/NP TR 37137-1 | Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants -- Part 1: Title missing | 2017-01-13 | 2017-01-13 | 10.99 | 2020-01-13 | 36 | ISO/TC 194/WG 15 | ||
| ISO/DTR 37137-2 | Cardiovascular biological evaluation of medical devices -- Guidance for absorbable implants -- Part 2: Standard guide for absorbable metals | 2016-03-11 | 2016-07-11 | 30.60 | ISO/TC 194/WG 15 | ||||
| ISO/DTR 21582 | Pyrogenicity -- Principle and method for pyrogen testing of medical devices | 2016-03-11 | 2016-07-11 | 30.60 | ISO/TC 194/WG 16 | ||||
| ISO/PRF TR 10993-22 | Biological evaluation of medical devices -- Part 22: Guidance on nanomaterials | 2014-07-18 | 2017-03-24 | 50.20
(Start date: 2017-03-24 End date: 2017-04-22) |
2017-04-22 | 36 | ISO/TC 194/WG 17 | ||
| ISO 13022:2012 | Medical products containing viable human cells -- Application of risk management and requirements for processing practices | 2008-12-22 | 2017-01-15 | 90.20
(Start date: 2017-01-15 End date: 2017-06-06) |
2017-06-06 | 2017-01-15 | 48 | ISO/TC 194/SC 1 | |
| ISO 22442-1:2015 | Medical
devices utilizing animal tissues and their derivatives -- Part 1: Application
of risk management |
2015-02-17 | 2015-11-02 | 60.60 | 2015-11-02 | 36 | ISO lead | ISO/TC 194/SC 1 | |
| ISO 22442-2:2015 | Medical
devices utilizing animal tissues and their derivatives -- Part 2: Controls on
sourcing, collection and handling |
2015-02-17 | 2015-11-02 | 60.60 | 2015-11-02 | 36 | ISO lead | ISO/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 |
2003-12-10 | 2015-09-17 | 90.93 | 2015-09-17 | 48 | ISO lead | ISO/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 | 2008-06-10 | 2016-04-22 | 90.93 | 2016-04-22 | ISO/TC 194/SC 1 |
Last update 2017.03.27
Copyright(C) 医療機器部