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DIN EN ISO 11137-1:2020-04

Действует
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 — 68 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

DIN EN ISO 11137-1:2015-11
Отменен
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) — 54 стр.
DIN EN ISO 11137-1/A2:2017-10
Проект
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/DAM 2:2017); German and English version prEN ISO 11137-1:2015/prA2:2017

На этот документ ссылаются

DIN EN ISO 20697:2019-04
Действует
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09); German version EN ISO 20697:2018 — 48 стр.
DIN EN ISO 20697:2018-10
Отменен
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018); German version EN ISO 20697:2018 — 47 стр.
DIN EN ISO 20696:2018-10
Отменен
Sterile urethral catheters for single use (ISO 20696:2018); German version EN ISO 20696:2018 — 41 стр.
DIN EN ISO 20696:2019-04
Отменен
Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2018-09); German version EN ISO 20696:2018 — 41 стр.
DIN EN ISO 22442-1:2016-05
Отменен
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015 — 43 стр.
DIN EN ISO 25539-2:2013-05
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012); German version EN ISO 25539-2:2012 — 115 стр.
DIN EN ISO 11607-1:2017-11
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO/DIS 11607-1:2017); German and English version prEN ISO 11607-1:2017 — 49 стр.
DIN EN ISO 11607-1:2017-10
Отменен
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017 — 49 стр.
DIN EN ISO 11070:2019-04
Действует
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018 — 38 стр.
DIN EN ISO 11070:2018-10
Отменен
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018 — 38 стр.
DIN EN ISO 11137-1:2015-11
Отменен
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) — 54 стр.
DIN EN ISO 11737-2:2010-04
Отменен
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009); German version EN ISO 11737-2:2009 — 28 стр.
DIN EN ISO 8637:2014-03
Отменен
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1:2013-04-01); German version EN ISO 8637:2014 — 30 стр.
DIN EN ISO 7199:2017-05
Отменен
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016); German version EN ISO 7199:2017 — 31 стр.
DIN EN ISO 5840-3:2013-06
Отменен
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013); German version EN ISO 5840-3:2013 — 122 стр.
DIN EN ISO 5840-1:2015-12
Отменен
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015); German version EN ISO 5840-1:2015 — 73 стр.
DIN EN ISO 5840-2:2016-05
Отменен
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015 — 71 стр.
DIN EN 13544-1:2009-12
Отменен
Respiratory therapy equipment - Part 1: Nebulizing systems and their components; German version EN 13544-1:2007+A1:2009 — 47 стр.