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.
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.
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 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 10993-9:2009)— 19 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2010— 83 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.
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 medical device materials within a risk management process (ISO 10993-18:2020); German version EN ISO 10993-18:2020— 96 стр.
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2020); German and English version prEN ISO 10993-2:2020
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014— 48 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1 (ISO 10993-7:2008/DAM 1:2018); German and English version EN ISO 10993-7:2008/prA1:2018
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO/DIS 10993-10:2020); German and English version prEN ISO 10993-10:2020
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010— 26 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018); German and English version prEN ISO 10993-15:2018
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017— 26 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.
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive Control Material (ISO 7405:2008/DAM 1:2012); German version EN ISO 7405:2008/prA1:2012
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.
Dentistry - Manual toothbrushes - General requirements and test methods (ISO 20126:2012 + Amd 1:2018); German version EN ISO 20126:2012 + A1:2018— 20 стр.
