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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
ОписаниеИзмененияСсылкиВерсии

На этот документ ссылаются

DIN EN ISO 11737-1:2018-07
Отменен
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018); German version EN ISO 11737-1:2018 — 75 стр.
DIN EN ISO 11607-1:2014-11
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 11607-1:2009 + A1:2014 — 45 стр.
DIN EN ISO 11737-1:2009-09
Отменен
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006); German version EN ISO 11737-1:2006 + AC:2009 — 48 стр.
DIN EN ISO 11137-3:2017-11
Действует
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 — 55 стр.
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.
DIN EN ISO 11137-3:2006-07
Отменен
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006); German version EN ISO 11137-3:2006 — 25 стр.
DIN EN ISO 15378:2016-03
Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015); German version EN ISO 15378:2015 — 85 стр.
DIN EN ISO 15378:2016-11
Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016 — 85 стр.
DIN EN ISO 15798:2014-02
Отменен
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013); German version EN ISO 15798:2013 — 28 стр.
DIN EN ISO 10555-1:2013-11
Отменен
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013); German version EN ISO 10555-1:2013 — 35 стр.
DIN EN ISO 8637-2:2018-12
Действует
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 — 30 стр.
DIN EN ISO 8638:2014-03
Отменен
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014 — 24 стр.
DIN EN ISO 6710:2017-12
Действует
Single-use containers for human venous blood specimen collection (ISO 6710:2017); German version EN ISO 6710:2017 — 29 стр.