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DIN Standards Committee Health Technologies

DIN EN ISO 18562-4 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-11 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More 
ISO 10993-13 2010-06 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices More 
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 10993-2 2022-11 Biological evaluation of medical devices - Part 2: Animal welfare requirements More 
ISO 10993-3 2014-10 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity More 
ISO 10993-9 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO/TS 10993-19 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials More