Coherence between risk analysis and instructions for use in the EU

Adrie de Bruijn

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Coherence between risk analysis and instructions for use in the EU

机译：风险分析与欧盟使用说明之间的一致性

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The essential requirements of the European medical device directives (Directive 93/42/EEC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostics) require that the solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. To minimise the risks involved in the use of the device, all known or foreseeable hazards should be identified, risks arising from the identified hazards should be estimated and the actions taken to eliminate or reduce the risks should be clearly described and proven to be adequate.

机译：欧洲医疗设备指令的基本要求（关于医疗设备的指令93/42 / EEC，关于有源植入式医疗设备的指令90/385 / EEC和关于体外诊断的指令98/79 / EC）要求该医疗机构采用的解决方案考虑到公认的最新技术，设备设计和制造的制造商必须遵守安全原则。为了最大程度地减少使用设备所涉及的风险，应识别所有已知或可预见的危害，应估算由已识别的危害引起的风险，并应清楚地描述消除或减少风险所采取的措施，并证明其是适当的。

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《Regulatory Affairs Journal- Devices》 |2011年第maraaapra期|共2页
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Adrie de Bruijn;
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Coherence between risk analysis and instructions for use in the EU

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