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.
General requirements for the competence of testing and calibration laboratories (ISO/IEC DIS 17025:2016); German and English version prEN ISO/IEC 17025:2016
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for verifying conformity or nonconformity with specifications (ISO/DIS 14253-1:2016); German and English version prEN ISO 14253-1:2016
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 - Substantiation of selected sterilization dose: Method VD<(Index)max><(hoch)SD> (ISO/TS 13004:2013); German version CEN ISO/TS 13004:2014
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.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012— 112 стр.
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 2: Guidance for the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification (ISO 14253-2:2011); German version EN ISO 14253-2:2011— 83 стр.
Geometrical product specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformity or nonconformity with specifications (ISO 14253-1:2013); German version EN ISO 14253-1:2013— 21 стр.
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, including Amd 1:2013)— 54 стр.
Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003— 56 стр.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015
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.
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.
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.
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.
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010); German version EN ISO 8638:2014— 24 стр.
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.
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.
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.
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.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018— 38 стр.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018— 38 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, including Amd 1:2013)— 54 стр.
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— 76 стр.
