BS EN ISO 10993-1:October 2009

Действует

Biological evaluation of medical devices. Evaluation and testing within a risk management process — 32 стр.

Ссылочные документы

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 10993-11:2006

Заменен

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.

ISO 10993-12:2012

Действует

Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.

ISO 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO 7405:2008/Amd.1:2013

Заменен

Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry -- Amendment 1: Positive control material — 6 стр.

ISO 9001:2015

Действует

Quality management systems -- Requirements — 40 стр.

ISO/IEC 17025:2017

Действует

General requirements for the competence of testing and calibration laboratories — 38 стр.

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 10993-6:2016

Действует

Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation — 36 стр.

ISO 10993-7:2008

Действует

Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals — 94 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 10993-13:2010

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 10993-19:2006

Действует

Biological evaluation of medical devices -- Part 19: Physicochemical, morphological and topographical characterization of materials — 22 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 9004:2018

Действует

Quality management -- Quality of an organization -- Guidance to achieve sustained success — 68 стр.

ISO 13485:2003

Заменен

Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.

BS EN ISO 10993-1:June 2009

Заменен

Biological evaluation of medical devices. Evaluation and testing — 26 стр.

На этот документ ссылаются

BS EN ISO 10993-1:June 2009

Заменен

Biological evaluation of medical devices. Evaluation and testing — 26 стр.

BS EN 13060:2014

Заменен

Small steam sterilizers — 82 стр.

BS EN ISO 10993-1:2003

Заменен

Biological evaluation of medical devices, Evaluation and testing — 26 стр.