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.
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)— 54 стр.
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011); German version EN ISO 14160:2011— 48 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014— 21 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 - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2015); German and English version prEN ISO 10993-11:2015
Animal tissue and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents; German version EN 12442-3:2000— 19 стр.
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling; German version EN 12442-2:2000— 14 стр.
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk; German version EN 12442-1:2000— 16 стр.
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO/DIS 14160:2009); German version prEN ISO 14160:2009
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2003— 30 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 75 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 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 2: Establishing the sterilization dose (ISO/DIS 11137-2:2009); German version prEN ISO 11137-2:2009
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.
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.
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO/DIS 10993-1:2006); German version prEN ISO 10993-1:2007
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 4: Selection of tests for interactions with blood (ISO 10993-4:2002+Amd.1:2006); German version EN ISO 10993-4:2002+A1:2006— 48 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.
