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SS EN 46002 Ed. 2 (1997)被替代

Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9002

出版:Standardiserings-Kommissionen I Sverige

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基本信息
標(biāo)準(zhǔn)編號(hào): SS EN 46002 Ed. 2 (1997)
發(fā)布時(shí)間:1997/1/17 0:00:00
標(biāo)準(zhǔn)類別:Standard
出版單位:Standardiserings-Kommissionen I Sverige
標(biāo)準(zhǔn)頁(yè)數(shù):24
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.

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

SS EN ISO 13488 Ed. 1 (2001)

等同采用的國(guó)際標(biāo)準(zhǔn)

SN EN 46002:1997 - Identical

DIN EN 46002 (1996-09) - Identical

ONORM EN 46002:1996 - Identical

BS EN 46002:1997 - Identical

I.S. EN 46002:1997 - Identical

UNE EN 46002:1996 - Identical

NF EN 46002:1996 - Identical