Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2009— 27 стр.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); German version EN ISO 10993-4:2009— 50 стр.
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 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999); German version EN ISO 10993-9:2009— 18 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, including Amd 1:2006); German version EN ISO 10993-10:2009— 68 стр.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007— 75 стр.
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (Revision of EN 46002:1996) (Identical to ISO 13488:1996); German version EN ISO 13488:2000— 13 стр.
General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005, Corrigenda to DIN EN ISO/IEC 17025:2005-08; German and English version EN ISO/IEC 17025:2005/AC:2006— 4 стр.
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); German version EN ISO 22803:2005— 14 стр.
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008— 113 стр.
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000); German version EN ISO 5366-1:2004— 22 стр.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); German version EN ISO 10993-3:2003— 25 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2005— 25 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); German version EN ISO 11137-1:2006— 49 стр.
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005); German version EN ISO 14408:2009— 14 стр.
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000); German version EN ISO 5366-1:2009— 24 стр.
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005); German version EN ISO 25539-1:2009— 112 стр.
