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EN 46002 : 1996被替代

QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002

出版：Comite Europeen de Normalisation

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基本信息
標(biāo)準(zhǔn)編號(hào)： EN 46002 : 1996
標(biāo)準(zhǔn)類別：Standard
出版單位：Comite Europeen de Normalisation
標(biāo)準(zhǔn)頁(yè)數(shù)：0
標(biāo)準(zhǔn)簡(jiǎn)介

Specifies the quality requirements for the production and, where relevant, installation of medical devices. Coverage includes: quality system requirements; product identification and traceability; inspection, measuring and test equipment; control of nonconforming product; handling, storage, packaging and delivery; internal quality audits. Also gives detailed definitions.