Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001, IDT)
This Malaysian Standard 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 in order to identify the degradation products. Because of the generalized nature of this standard, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first.
This Malaysian Standard considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered.
Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified.
Although these materials are intended for biomedical applications, the biological activity of these degradation products is n
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29/05/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
