Standard Swedish standard · 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

Status: Withdrawn

· Replaced by: SS-EN ISO 22442-3:2007
Scope
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).

Subjects

General (11.120.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-29948

Edition: 1

Approved: 3/30/2001

No of pages: 28

Replaced by: SS-EN ISO 22442-3:2007