BS EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
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).
Tissues and derivatives for use in medical devices are typically obtained by the manufacturer from a range of sources such as animal herds or flocks and commercial harvesting (including fishing). Some specialized industries also process materials of animal origin to manufacture a finished product (e.g. gelatine) which is incorporated as a raw material into the finished medical device by the manufacturer.
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.
Contents include:
- Introduction
- Scope
- Normative references
- Terms and definitions
- General requirements
- Quality system elements
- Procedures
- Personnel
- Current regulatory requirements and guidance
- Sourcing
- Species and strain
- Geography
- Inspection
- Certification
- Traceability
- Collection
- Handling
- Storage and transport
- Additional requirements relating to the application of this part of ISO 22442 to bovine-sourced materials
- Certification and attestation
- Veterinary services
- Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Directive 2003/32/EC
- Bibliography
Part 2 of BS EN ISO 22442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in BS EN ISO 22442-1.
Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management.
Manufacturers should refer to BS EN ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents.
BS EN ISO 22442-2 does not cover the utilization of human tissues in medical devices, nor does it specify a quality management system for the control of all stages of production of medical devices.
It is not a requirement of this part of BS EN ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see BS EN ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of BS EN ISO 22442 can form a part of a quality management system conforming to BS EN ISO 13485.
A general principle for the application of BS EN ISO 22442 is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.
BS EN ISO 22442-2:2007 replaces BS EN 12442-2:2000 which has been withdrawn.