SS-EN-12442-3 Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents

SS-EN-12442-3 - EDITION 1 - SUPERSEDED
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1.1 This Part of EN 12442 specifies requirements for the validation of elimination and/or inactivation of viruses and/or transmissible agents during the manufacture of medical devices (excluding in-vitro diagnostic medical devices) utilizing materials of animal origin. It is not applicable to bacteria, moulds and yeasts. NOTE 1: Analysis and management of risk and conventional processes used for sterilization, when used for the treatment of animal tissues for medical devices, have not been shown to be completely effective in inactivating the causative agents of spongiform encephalopathies. Selective sourcing is extremely important (see EN 12442-1 and EN 12442-2) . NOTE 2: EN 550, EN 552, EN 554, ISO 14160 and EN 1174 may be relevant for bacteria, moulds and yeast (see Bibliography).

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Designation Name

SS-EN 12442-3

Revision Level

EDITION 1

Status

Superseded

Publication Date

March 30, 2001

Language(s)

English

Page Count

28

International Equivalent

EN 12442-3:2000 IDT