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NEN EN 12442-1:2000被替代

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

出版:Nederlands Normalisatie Instituut

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基本信息
标准编号: NEN EN 12442-1:2000
发布时间:2000/10/1 0:00:00
标准类别:Standard
出版单位:Nederlands Normalisatie Instituut
标准页数:20
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).

标准备注

To be used in conjunction with EN 1441. (09/2002)

替代本标准的新标准

NEN EN ISO 22442-1:2008

等同采用的国际标准

UNI EN 12442-1:2002 - Identical

NBN EN 12442-1:2000 - Identical

NF EN 12442-1:2000 - Identical

ONORM EN 12442-1:2000 - Identical

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

BS EN 12442-1:2000 - Identical

SN EN 12442-1:2000 - Identical

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

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

UNE EN 12442-1:2001 - Identical

SS EN 12442-1 Ed. 1 (2001) - Identical