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ÖNORM EN ISO 10993-1:2021-04

Действует
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
ISO 10993-3:2014
Действует
Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity — 42 стр.
ISO 10993-4:2002/Amd.1:2006
Заменен
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood -- Amendment 1 — 10 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
ISO 10993-6:2007
Заменен
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 28 стр.
ISO 10993-7:2008/Cor.1:2009
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 стр.
ISO 10993-9:2009
Действует
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products — 16 стр.
ISO 10993-10:2010
Действует
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.
ISO 10993-11:2017
Действует
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 36 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ISO 10993-13:2010
Действует
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices — 22 стр.
ISO 10993-14:2001
Действует
Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics — 18 стр.
ISO 10993-15:2000
Действует
Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys — 20 стр.
ISO 10993-16:2010
Заменен
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.
ISO/TS 10993-20:2006
Действует
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices — 24 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ÖNORM EN ISO 10993-1:2011-03
Заменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)

На этот документ ссылаются

ÖNORM EN ISO 10993-1:2011-03
Заменен
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)