标准编号：ISO/TR 15499:2016
中文名称：医疗器械的生物学评价 风险管理过程中生物学评价的实施指南
英文名称：Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
发布日期：2016-12
标准范围
This Technical Report is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This Technical Report does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.This guidance is applicable to all biological evaluation of all types of medical devices including active, nonactive, implantable and non-implantable medical devices.
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