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유럽 의료기기 CE MDR

[CE]Essential Requirements - MDD

관리자
2016-08-17 19:16:00
hit780
112.161.21.76

유럽의 Medical Device Directive 93/42/EEC 에서는 의료기기의 필수요구조건을 고시하고 있다.

Article 3 Essential Requirements

The devices must meet the essential requirements set out in Annex 1 which apply to them, taking account of the intended purpose of the devices concerned.

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council o f17 May 2006 on machinery (5) shall also meet the essential health and safety requirements set out in Annes I to that Directive to the extent to which those essential health an d safety requirements are more spevific than the essential requirements set out in Annex I to this Directive.

의료기기는 부속서 I에 나타난 필수요구조건을 만족시켜야 한다.

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출력

councildirective93_42_eec_annexi_essentialrequirements.pdf 66,359byte