AS EN 12442.1-2003

Specifies a procedure to investigate, using available information, the safety of medical devices by identifying hazards and estimating the risks associated with the device (risk analysis). This Standrad 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 have been rendererd non-viable.

1.1 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 have been rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices byidentifying hazards and estimating the risks associated with the device (risk analysis).1.2 This Part of EN 12442 is intended to provide requirements and guidance on risk analysis related to the typical hazards of medical devices manufactured utilizing animal tissues or derivatives such asa) contamination by bacteria, moulds or yeasts;b) contamination by viruses or transmissible agents such as pathogenic entities, or agents causing spongiform encephalopathies, prions and similar entities (e.g. BSE, scrapie);c) undesired pyrogenic, immunological or toxicological reactions.1.3 This Part of EN 12442 does not stipulate levels of acceptability which, because theyare determined by a multiplicity of factors, cannot be set down in such a standard.1.4 In addition, this Part of EN 12442 is intended to provide requirements and guidanceon risk management.1.5 This Part of EN 12442 does not cover the utilization of human tissues in medical devices.NOTE: There are materials which do not fall under the scope of this standard because these are not derived from animals. In this standard a specific definition of animal has been given.1.6 This Part of EN 12442 does not describe a quality assurance system for the control ofall stages of manufacture.NOTE: Attention is drawn to the standards for quality systems (see EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002) which relate to all stages of manufacture.It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system are required.1.7 The principles of this Part of EN 12442 may also be applied by analogy to medical devices manufactured utilizing material derived from a non-vertebrate organism, in cases where the risks addressed in this standard are relevant.

First published as AS EN 12442.1-2003.