Firefox https://dmd.nihs.go.jp/chikyukibo/Evaluation/TC194_published_items...

Stage現状
文書番号 文書名 担当 発行日
（ISO HPを参照）
Biological evaluation of medical devices — Part 1:
ISO 10993-1:2018 ISO/TC 194/WG 1 2018/8/17 60.60
Evaluation and testing within a risk management process
Biological evaluation of medical devices — Part 2: Animal
ISO 10993-2:2006 ISO/TC 194/WG 3 2019/6/25 90.92
welfare requirements
Biological evaluation of medical devices — Part 3: Tests for
ISO 10993-3:2014 ISO/TC 194/WG 6 2019/12/16 90.92
genotoxicity, carcinogenicity and reproductive toxicity
Biological evaluation of medical devices — Part 4: Selection
ISO 10993-4:2017 ISO/TC 194/WG 9 2017/4/12 60.60
of tests for interactions with blood
Biological evaluation of medical devices — Part 5: Tests for
ISO 10993-5:2009 ISO/TC 194/WG 5 2017/2/9 90.93
in vitro cytotoxicity
Biological evaluation of medical devices — Part 6: Tests for
ISO 10993-6:2016 ISO/TC 194/WG 10 2016/11/28 60.60
local effects after implantation
Biological evaluation of medical devices — Part 7: Ethylene
ISO 10993-7:2008 ISO/TC 194/WG 11 2016/11/28 90.93
oxide sterilization residuals
Biological evaluation of medical devices — Part 7: Ethylene
ISO 10993-7:2008/Amd 1:2019 oxide sterilization residuals — Amendment 1: Applicability of ISO/TC 194/WG 11 2019/12/9 60.60
allowable limits for neonates and infants
Biological evaluation of medical devices — Part 7: Ethylene
ISO 10993-7:2008/Cor 1:2009 ISO/TC 194/WG 11 2009/11/12 60.60
oxide sterilization residuals — Technical Corrigendum 1
Biological evaluation of medical devices — Part 9:
ISO 10993-9:2019 Framework for identification and quantification of potential ISO/TC 194/WG 2 2019/11/26 60.60
degradation products
Biological evaluation of medical devices — Part 10: Tests for
ISO 10993-10:2010 ISO/TC 194/WG 8 2018/1/12 90.92
irritation and skin sensitization
Biological evaluation of medical devices — Part 11: Tests for
ISO 10993-11:2017 ISO/TC 194/WG 7 2017/9/14 60.60
systemic toxicity
Biological evaluation of medical devices — Part 12: Sample
ISO 10993-12:2021 ISO/TC 194/WG 12 2021/1/20 60.60
preparation and reference materials
Biological evaluation of medical devices — Part 13:
ISO 10993-13:2010 Identification and quantification of degradation products from ISO/TC 194/WG 2 2019/5/2 90.93
polymeric medical devices
Biological evaluation of medical devices — Part 14:
ISO 10993-14:2001 Identification and quantification of degradation products from ISO/TC 194/WG 2 2019/5/2 90.93
ceramics
Biological evaluation of medical devices — Part 15:
ISO 10993-15:2019 Identification and quantification of degradation products from ISO/TC 194/WG 2 2019/11/26 60.60
metals and alloys
Biological evaluation of medical devices — Part 16:
ISO 10993-16:2017 Toxicokinetic study design for degradation products and ISO/TC 194/WG 13 2017/5/16 60.60
leachables
Biological evaluation of medical devices — Part 17:
ISO 10993-17:2002 ISO/TC 194/WG 11 2018/1/19 90.92
Establishment of allowable limits for leachable substances
Biological evaluation of medical devices — Part 18:
ISO 10993-18:2020 Chemical characterization of medical device materials within ISO/TC 194/WG 14 2020/1/13 60.60
a risk management process
Biological evaluation of medical devices — Part 19: Physico-
ISO/TS 10993-19:2020 chemical, morphological and topographical characterization ISO/TC 194/WG 14 2020/3/12 60.60
of materials
Biological evaluation of medical devices — Part 20:
ISO/TS 10993-20:2006 Principles and methods for immunotoxicology testing of ISO/TC 194/WG 7 2014/10/10 90.93
medical devices
Biological evaluation of medical devices — Part 22:
ISO/TR 10993-22:2017 ISO/TC 194/WG 17 2017/7/14 60.60
Guidance on nanomaterials
Biological evaluation of medical devices — Part 23: Tests for
ISO 10993-23:2021 ISO/TC 194/WG 8 2021/1/20 60.60
irritation
Biological evaluation of medical devices — Part 33:
ISO/TR 10993-33:2015 Guidance on tests to evaluate genotoxicity — Supplement to ISO/TC 194/WG 6 2015/3/6 60.60
ISO 10993-3
Medical products containing viable human cells —
ISO 13022:2012 Application of risk management and requirements for ISO/TC 194 2017/6/7 90.93
processing practices
Clinical investigation of medical devices for human subjects
ISO 14155:2020 ISO/TC 194/WG 4 2020/7/28 60.60
— Good clinical practice

1 de 2 22/03/2023, 11:16
Firefox https://dmd.nihs.go.jp/chikyukibo/Evaluation/TC194_published_items...

Biological evaluation of medical devices — Application of the

ISO/TS 21726:2019 threshold of toxicological concern (TTC) for assessing ISO/TC 194/WG 11 2019/2/1 60.60
biocompatibility of medical device constituents
Medical devices utilizing animal tissues and their derivatives
ISO 22442-1:2020 ISO/TC 194 2020/9/15 60.60
— Part 1: Application of risk management
Medical devices utilizing animal tissues and their derivatives
ISO 22442-2:2020 ISO/TC 194 2020/9/15 60.60
— Part 2: Controls on sourcing, collection and handling
Medical devices utilizing animal tissues and their derivatives
— Part 3: Validation of the elimination and/or inactivation of
ISO 22442-3:2007 ISO/TC 194 2015/9/17 90.93
viruses and transmissible spongiform encephalopathy (TSE)
agents
Medical devices utilizing animal tissues and their derivatives
— Part 4: Principles for elimination and/or inactivation of
ISO/TR 22442-4:2010 ISO/TC 194 2016/4/22 90.93
transmissible spongiform encephalopathy (TSE) agents and
validation assays for those processes
Cardiovascular biological evaluation of medical devices —
ISO/TR 37137:2014 ISO/TC 194 2016/4/7 90.92
Guidance for absorbable implants
Biological evaluation of absorbable medical devices — Part
ISO/TS 37137-1:2021 ISO/TC 194/WG 2 2021/3/12 60.60
1: General requirements

2 de 2 22/03/2023, 11:16