NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 10993-18 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-9 2019-11 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products More 
ISO 22442-1 2020-09 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management 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 
ISO 5725-1 2023-07 Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions More 
ISO/TR 10993-22 2017-07 Biological evaluation of medical devices - Part 22: Guidance on nanomaterials More 
ISO/TS 10993-19 2020-03 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials More 
ISO/TS 21726 2019-02 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents More