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NEN EN ISO 13485:2003被替代

Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes

出版：Nederlands Normalisatie Instituut

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基本信息

標(biāo)準(zhǔn)編號(hào)： NEN EN ISO 13485:2003

發(fā)布時(shí)間：2003/8/1 0:00:00

標(biāo)準(zhǔn)類(lèi)別：Standard

出版單位：Nederlands Normalisatie Instituut

標(biāo)準(zhǔn)頁(yè)數(shù)：83

標(biāo)準(zhǔn)簡(jiǎn)介

Describes the 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.

標(biāo)準(zhǔn)備注

Supersedes NEN EN 46001. (07/2002) Supersedes NEN EN ISO 13488. (09/2003) Supersedes NEN EN 46003. (02/2008)

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

NEN EN ISO 13488:2000

NEN EN 46003:1999

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

NEN EN ISO 13485:2012

等同采用的國(guó)際標(biāo)準(zhǔn)

ONORM EN ISO 13485:2010 - Identical

SN EN ISO 13485:2003 - Identical

BS EN ISO 13485:2003 - Identical

DIN EN ISO 13485 (2007-10) - Identical