Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007); German version EN ISO 10993-6:2009— 31 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.
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 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.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010); German version EN ISO 10993-16:2010— 23 стр.
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)— 19 стр.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); German version EN ISO 11135-1:2007— 52 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, Corrigendum to DIN EN ISO 11137-2:2007-09; German version EN ISO 11137-2:2007/AC:2009— 2 стр.
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2009); German version prEN ISO 15223-1:2009
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999); German version EN ISO 10993-9:1999— 7 стр.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); German version EN ISO 10993-16:1997— 8 стр.
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.
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.
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); German version EN ISO 15798:2001, Corrigenda to DIN EN ISO 15798:2001-12; German version EN ISO 15798:2001/AC:2005— 2 стр.
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001); German version EN ISO 15798:2001, Corrigenda to DIN EN ISO 15798:2001-12; German version EN ISO 15798:2001/AC:2005— 2 стр.
