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SS EN 12442-1 Ed. 1 (2001)被替代

Animal Tissues And Their Derivatives Utilized In The Manufacture Of Medical Devices - Part 1: Analysis And Management Of Risk

出版:Standardiserings-Kommissionen I Sverige

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基本信息
标准编号: SS EN 12442-1 Ed. 1 (2001)
发布时间:2001/3/30 0:00:00
标准类别:Standard
出版单位:Standardiserings-Kommissionen I Sverige
标准页数:21
标准简介

Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).

替代本标准的新标准

SS EN ISO 22442-1 Ed. 1 (2007)

等同采用的国际标准

NBN EN 12442-1:2000 - Identical

NF EN 12442-1:2000 - Identical

UNE EN 12442-1:2001 - Identical

I.S. EN 12442-1:2000 - Identical

NEN EN 12442-1:2000 - Identical

ONORM EN 12442-1:2000 - Identical

SN EN 12442-1:2000 - Identical

DIN EN 12442-1 (2001-01) - Identical

BS EN 12442-1:2000 - Identical

UNI EN 12442-1:2002 - Identical

NS EN 12442-1 Ed. 1 (2000) - Identical