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EVS-EN ISO 10993-14:2009

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

General information
Valid from 07.08.2009
Base Documents
ISO 10993-14:2001; EN ISO 10993-14:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
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This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics(including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions inorder to identify the degradation products. Because of the generalized nature of this part of ISO 10993, productspecific standards, when available, that address degradation product formation under more relevant conditions ofuse, should be considered first.This part of ISO 10993 considers only those degradation products generated by a chemical dissociation ofceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It isnoted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis ofdegradation products.
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