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DIN EN ISO 11135/A1:2017-09

Отменен
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014/DAM 1:2017); German and English version EN ISO 11135:2014/prA1:2017
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DIN EN ISO 25539-1:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005); German version EN ISO 25539-1:2009 — 112 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 18369-1:2010-05
Отменен
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications (ISO 18369-1:2006 + Amd.1:2009); German version EN ISO 18369-1:2006 + A1:2009 — 64 стр.
DIN EN ISO 17664:2004-07
Отменен
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004); German version EN ISO 17664:2004 — 23 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 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 11070:2015-03
Отменен
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014); German version EN ISO 11070:2014 — 36 стр.
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 11135:2020-04
Действует
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019) — 115 стр.