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Description of BS EN ISO 10993-14:2009 2009This part of ISOÂ 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 ISOÂ 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISOÂ 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 ISOÂ 6872 and ISOÂ 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 ISOÂ 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 ISOÂ 10993.
About BSIBSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses. |
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