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文献详情 >医疗器械的生物评定.第1部分:评定和试验 收藏
医疗器械的生物评定.第1部分:评定和试验

医疗器械的生物评定.第1部分:评定和试验

Biological evaluation of medical devices. Evaluation and testing within a risk management process. Replaces BS EN ISO 10993-1:2009 which is the implementation of EN ISO 10993-1-2009 June edition.

标准编号:BS EN ISO 10993-1-2009

发布日期:2010年

实施日期:20100630

页      码:32页

主      题:生物测定 生物适应性 生物的 生物分析和测试 生物危害 Bioassay Biocompatibility Biological Biological analysis and testing Biological hazards Biological tests Categories Classification Compatibility Definitions Evaluations Fine mechanics Fitness for purpose Human body Implants (surgical) Medical devices Medical equipment Medical products Medical sciences Medical technology Principles Selection Surgical equipment Testing Use 

国际标准分类号:11;11.100.20

摘      要:This part of ISO 10993 describes:- the general principles governing the biological evaluation of medical devices within a risk managementprocess;- the general categorization of devices based on the nature and duration of their contact with the body;- the evaluation of existing relevant data from all sources;- the identification of gaps in the available data set on the basis of a risk analysis;- the identification of additional data sets necessary to analyse the biological safety of the medical device;- the assessment of the biological safety of the medical device.This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirectcontact with the patient s body, nor does it cover biological hazards arising from any mechanical failure. Otherparts of ISO 10993 cover specific tests, as indicated in the Foreword.

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