BS EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives. Application of risk management
Certain medical devices utilize materials of animal origin.
Animal tissues and their derivatives are used in the design and manufacture of medical devices to provide performance characteristics that have been chosen for advantages over non-animal based materials. The range and quantities of materials of animal origin in medical devices vary. These materials can comprise a major part of the device (e.g. bovine/porcine heart valves, bone substitutes for use in dental or orthopaedic applications, haemostatic devices), can be a product coating or impregnation (e.g. collagen, gelatine, heparin), or can be used in the device manufacturing process (e.g. tallow derivatives such as oleates and stearates, foetal calf serum, enzymes, culture media).
BS EN ISO 14971 is a general standard which specifies a process for a manufacturer by identifying hazards and hazardous situations associated with medical devices, including in vitro medical devices, to estimate and evaluate the risks associated with those hazards, to control these risks and to monitor the effectiveness of the control throughout the life cycle. This part of BS EN ISO 22442 provides additional requirements and guidance for the evaluation of medical devices manufactured utilizing animal tissues or derivatives which are non-viable or rendered non-viable.
Part 1 of BS EN ISO 22442 is intended to cover medical devices including active implantable medical devices such as implantable infusion pumps.
BS EN ISO 22442-1 does not apply to in vitro diagnostic devices. This part of BS EN ISO 22442 can only be used in combination with BS EN ISO 14971 and is not a “stand-alone” Standard.
To show compliance with this part of BS EN ISO 22442, its specified requirements should be fulfilled. The guidance given in the Notes and informative annexes is not normative and is not provided as a checklist for auditors.
- Normative references
- Terms and definitions
- Risk management process
- Risk analysis, evaluation and control
- Evaluation of overall residual risk acceptability
- Production and post-production information system
- Guidance on the application of this part of ISO 22442
- Graphical representation of part of the risk management process for medical devices utilizing animal material
- Special requirements for some animal materials considering the risk management for TSE agents
- Information relevant to the management of TSE risk
- Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC as amended by Commission Directive 2003/32/EC
This part of BS EN ISO 22442 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 BS EN 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 BS EN ISO 14971, and expected medical benefit as compared to available alternatives. BS EN ISO 22442-1 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.
For parasites and other unclassified pathogenic entities, similar principles can apply.
BS EN ISO 22442-1 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
Part 1 of BS EN ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices, nor does it cover the utilization of human tissues in medical devices.
It is not a requirement of BS EN ISO 22442-1 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see BS EN ISO 13485) that control all stages of production or reprocessing of medical devices.
BS EN ISO 22442-1:2007 replaces BS EN 12442-1:2000 which has been withdrawn.