Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007)
Abstract
ISO 22442-1:2007 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. ISO 22442-1:2007 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
- contamination by bacteria, moulds or yeasts;
- contamination by viruses;
- contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
- material responsible for undesired pyrogenic, immunological or toxicological reactions.
DIN EN ISO 22442-1:2008-03 (E)
Medical devices utilizing animal tissues and their derivatives – Part 1: Application of
risk management (I SO 22442-1:2007)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Risk management process ………………………………………………………………………………………………7
4.1 General …………………………………………………………………………………………………………………………..7
4.2 Risk analysis …………………………………………………………………………………………………………………..8
4.3 Risk evaluation ……………………………………………………………………………………………………………….9
4.4 Risk control …………………………………………………………………………………………………………………….9
4.5 Evaluation of overall residual risk acceptability ……………………………………………………………..11
4.6 Production and post-production information system ……………………………………………………..11
Annex A (informative) Guidance an the application of this part of ISO 22442 …………………………………12
Annex B (informative) Graphical representation of part of the risk management process formedical
devices utilizing animal material ……………………………………………………………………………………13
Annex C (normative) Special requirements for some animal materials considering the risk
management for TSE agents ………………………………………………………………………………………….15
Annex D (informative) Information relevant to the management of TSE risk …………………………………..20
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Directive
2003/32/EC ……………………………………………………………………………………………………………………28
Bibliography …………………………………………………………………………………………………………………………………29