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.
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013); German version EN ISO 13408-1:2015— 70 стр.
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 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013— 83 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); Corrigendum 1 to English translation of DIN EN ISO 10993-7:2009-02— 3 стр.
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2014); German version prEN ISO 10993-6:2014
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
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2009— 17 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.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2009— 17 стр.
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2009— 32 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002); German version EN ISO 10993-10:2002— 55 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995); German version EN ISO 10993-7:1995— 34 стр.
Biological evaluation of medical devices - Part 5: Tests for cytotoxicity: in vitro-methods (ISO 10993-5:1999); German version EN ISO 10993-5:1999— 8 стр.
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994); German version EN 30993-6:1994— 10 стр.
Biological evaluation of medical devices; part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992); German version EN 30993-3:1993— 8 стр.
