
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
出版:Comite Europeen de Normalisation

专家解读视频
基本信息
标准编号: EN 46002 : 1996
标准类别:Standard
出版单位:Comite Europeen de Normalisation
标准页数:0
标准简介
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.