SR EN 12442-1:2002

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk

This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).

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General information

Status : Withdrawn
Approval date : 9/26/2002
Publish date : 9/27/2002
Withdrawal date : 5/27/2008
Number of pages : 24
ICS : 11.120.01 Pharmaceutics in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Normative reference SR EN 12442-3:2002
Normative reference SR EN 12442-2:2002
Replaced by SR EN ISO 22442-1:2008