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EN ISO 10993-14:2009 Standard



#part #address #chemical #analysis #solutions


Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017


Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)


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.


Friday 17th of November 2017


This standard superseed the "EN ISO 10993-14:2001".

Anyway is still possible use the "EN ISO 10993-14:2001" until March 21st, 2010

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