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BS EN 12442-1:2000被替代

Animal tissues and their derivatives utilized in the manufacture of medical devices. Analysis and management of risk

出版：British Standards Institution

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基本信息

標準編號： BS EN 12442-1:2000

發布時間：2000/11/15 0:00:00

標準類別：Standard

出版單位：British Standards Institution

標準頁數：24

標準簡介

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).

標準備注

? British Standards Institution 2013

本標準替代的舊標準

96/562030 DC

96/562030 DC : JUL 96

替代本標準的新標準

BS EN ISO 22442-1:2007

等同采用的國際標準

NBN EN 12442-1:2000 - Identical

NEN EN 12442-1:2000 - Identical

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

UNE EN 12442-1:2001 - Identical