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现行 ISO/TR 22979:2017
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Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications 眼内植入物 - 眼内镜片 - 眼内镜设计修改临床调查需求评估指导
发布日期: 2017-04-27
ISO/TR 22979:2017为人工晶状体(IOL)的ISO 11979系列国际标准的所有部分的应用提供了指导。【1?9】它阐述了根据ISO 14971对前房和后房人工晶状体进行修改的风险管理过程中需要考虑的因素。[11]它还提出了可用于确定临床研究及其设计需求的数据分析和解释方法。
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.
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归口单位: ISO/TC 172/SC 7
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