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DIN Standards Committee Optics and Precision Mechanics

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DIN EN ISO 22442-1 [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 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 22442-2 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling More 
ISO 22442-3 2007-12 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents More 
DIN EN ISO 10993-1 2021-05 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 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 10993-12 2021-08 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021); German version EN ISO 10993-12:2021 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