DIN EN ISO 10993-1:2010
医疗器械的生物学评价.第1部分:在风险管理系统内的评价与试验

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009

被代替

标准号

DIN EN ISO 10993-1:2010

发布

2010年

发布单位

德国标准化学会

替代标准

DIN EN ISO 10993-1:2017

当前最新

DIN EN ISO 10993-1:2010

DIN EN ISO 10993-1:2017

 

 

引用标准

ISO 10993-10 ISO 10993-11 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-15 ISO 10993-16 ISO 10993-17 ISO 10993-18 ISO 10993-19 ISO 10993-2 ISO 10993-20 ISO 10993-3 ISO 10993-4 ISO 10993-5 ISO 10993-6 ISO 10993-7 ISO 10993-9 ISO 14971

被代替标准

DIN EN ISO 10993-1:2009 DIN EN ISO 10993-1:2007

适用范围

The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the number and exposure of test animals by giving preference to chemical constituent testing and in vitro models, in situations where these methods yield equally relevant information to that obtained from in vivo models. It is not intended that this international standard will provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical devices. Where a particular application warrants it, experts in the product or in the area of application concerned can choose to establish specific tests and criteria, described in a product-specific vertical standard. This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device, taking into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.

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