Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020
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.
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)— 98 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.
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009— 28 стр.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009— 35 стр.
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd. 1:2013); German version EN ISO 7405:2008 + A1:2013— 45 стр.
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018— 56 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.
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.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012— 33 стр.