Каталог стандартов

+7 (495) 223-46-76 +7 (812) 309-78-59
inform@normdocs.ru
О компании Стандарты Контакты Заказать стандарт
СтандартыBSI

BS EN ISO 14160:2011

Действует
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices — 44 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 11135-1:2007
Заменен
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — 48 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ISO 9004:2018
Действует
Quality management -- Quality of an organization -- Guidance to achieve sustained success — 68 стр.
ISO 11737-1:2006
Заменен
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products — 42 стр.
ISO 13408-7:2012
Действует
Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products — 26 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 22442-2:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling — 24 стр.
ISO 11137-1:2006/Amd.1:2013
Действует
Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 1 — 10 стр.
ISO 11138-1:2017
Действует
Sterilization of health care products -- Biological indicators -- Part 1: General requirements — 48 стр.
ISO 22442-3:2007
Действует
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 — 30 стр.
BS ISO/IEC 90003:2014
Действует
Software engineering. Guidelines for the application of ISO 9001:2008 to computer software — 64 стр.
BS EN 556-1:2001
Действует
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices — 12 стр.
ISO/TS 11139:2006
Заменен
Sterilization of health care products -- Vocabulary — 20 стр.
ISO 11737-2:2009
Действует
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process — 24 стр.
ISO 14161:2009
Действует
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results — 70 стр.
ISO 14937:2009
Действует
Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — 46 стр.
ISO 17665-1:2006
Действует
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices — 48 стр.
ISO 22442-1:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management — 34 стр.
BS EN ISO 14160:1998
Заменен
Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants — 34 стр.

На этот документ ссылаются

BS EN ISO 14160:1998
Заменен
Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants — 34 стр.
BS EN ISO 7198:2017
Действует
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.
BS EN 556-2:2015
Действует
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices — 20 стр.