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.
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005— 73 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006); German version EN ISO 11137-2:2006— 76 стр.
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); German version EN ISO 11137-1:2006— 49 стр.
General requirements for the competence of testing and calibration laboratories (ISO/IEC DIS 17025:2016); German and English version prEN ISO/IEC 17025:2016
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015— 92 стр.
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
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.
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000— 29 стр.
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 (ISO 22442-3:2007); German version EN ISO 22442-3:2007— 31 стр.
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000— 29 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005); German version EN ISO 11140-1:2009— 39 стр.
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); German version EN ISO 11137-1:2006— 49 стр.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013— 64 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2013— 86 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012); German version EN ISO 11137-2:2012— 86 стр.
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014— 43 стр.
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— 48 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01); German version EN ISO 11137-2:2007— 76 стр.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006— 33 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/FDIS 11137-2:2012); German version FprEN ISO 11137-2:2012— 86 стр.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006); German version EN ISO 11137-2:2006— 76 стр.
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011— 21 стр.
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009— 27 стр.
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015); German version EN ISO 1135-5:2015— 34 стр.
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017— 76 стр.
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015); Text in German and English— 68 стр.
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); German version EN ISO 11138-1:2006— 48 стр.
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.
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.
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.
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015— 28 стр.
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010 + Amd 1:2013); German version EN ISO 8536-4:2013 + A1:2013— 26 стр.
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.
