Каталог стандартов

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

PD ISO/TS 19930:2017

Действует
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 — 32 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO/TS 13004:2013
Действует
Sterilization of health care products -- Radiation -- Substantiation of selected sterilization dose: Method VDmaxSD — 64 стр.
ISO 11607-1:2006/Amd.1:2014
Действует
Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems -- Amendment 1 — 16 стр.
ISO 14001:2015
Действует
Environmental management systems -- Requirements with guidance for use — 44 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 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 — 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 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 11607-2:2006/Amd.1:2014
Действует
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1 — 8 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.
ISO/IEC Guide 51:2014
Действует
Safety aspects -- Guidelines for their inclusion in standards — 22 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 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 11137-2:2013
Действует
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose — 76 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 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 11137-1:2006
Действует
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices — 44 стр.
ISO 9004:2009
Заменен
Managing for the sustained success of an organization -- A quality management approach — 54 стр.
ISO 14161:2009
Действует
Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results — 70 стр.
ISO 9001:2015
Действует
Quality management systems -- Requirements — 40 стр.
ISO 20857:2010
Действует
Sterilization of health care products -- Dry heat -- Requirements for the development, validation and routine control of a sterilization process for medical devices — 68 стр.
ISO 22442-1:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management — 34 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 14040:2006
Действует
Environmental management -- Life cycle assessment -- Principles and framework — 28 стр.