NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 22442-1 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-14 2001-11 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics More 
ISO 10993-15 2019-11 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys More 
ISO 10993-16 2017-05 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables More 
ISO 10993-18 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process More 
ISO 10993-3 2014-10 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More 
ISO 10993-4 2017-04 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood 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 10993-7 2008-10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals More 
ISO 10993-9 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More