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DIN Standards Committee Health Technologies

DIN EN ISO 23500-4 [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 10993-10 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization More 
ISO 10993-11 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity More 
ISO 10993-12 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials 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 10993-17 2023-09 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents 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