NA 014

DIN Standards Committee Dentistry

DIN EN ISO 7405 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-1 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More 
ISO 10993-11 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More 
ISO 10993-3 2014-10 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More 
ISO 10993-5 2009-06 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More 
ISO 10993-6 2016-12 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation More 
ISO 16443 2014-07 Dentistry - Vocabulary for dental implants systems and related procedure More 
DIN EN ISO 10993-11 2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 More 
DIN EN ISO 10993-13 2010-11 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 More 
DIN EN ISO 10993-14 2009-08 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 More 
DIN EN ISO 10993-16 2018-02 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 More