EN ISO 10993-14-2009

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


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标准号
EN ISO 10993-14-2009
发布日期
2009年04月01日
实施日期
2009年06月30日
废止日期
中国标准分类号
/
国际标准分类号
/
发布单位
CEN - European Committee for Standardization
引用标准
22
适用范围
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 in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993@ product specific standards@ when available@ that address degradation product formation under more relevant conditions of use@ should be considered first. This part of ISO 10993 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. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests@ they do not address the analysis of degradation products. 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. Further@ this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products. Although these materials are intended for biomedical applications@ the biological activity of these degradation products is not addressed in this part of ISO 10993.

EN ISO 10993-14-2009系列标准





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