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DS EN ISO 13485:2012被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Danish Standards
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基本信息
標(biāo)準(zhǔn)編號： DS EN ISO 13485:2012
發(fā)布時間：2012/3/9 0:00:00
標(biāo)準(zhǔn)類別：Standard
出版單位：Danish Standards
標(biāo)準(zhǔn)頁數(shù)：104
標(biāo)準(zhǔn)簡介
Defines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)
等同采用的國際標(biāo)準(zhǔn)
EN ISO 13485:2016 - Identical
