BS EN ISO 22442-3:2007

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
  4.1 Risk management
  4.2 Sourcing and manufacturing process
  4.3 General requirements related to validation
5 Literature review
  5.1 Conduct of the literature review
  5.2 Application of literature review output
  5.3 Viruses
  5.4 TSE agents
6 Elimination and/or inactivation study of viruses and TSE
  agents
  6.1 General
  6.2 Protocol
  6.3 Conduct of the study
  6.4 Interpretation of data
7 Final report
8 Review of final report
9 Routine monitoring and control of critical process parameters
Annex A (normative) - Requirements related to literature review
Annex B (informative) - Guidance on the elimination and/or
                        inactivation study for viruses
Annex C (informative) - Guidance on the elimination and/or
                        inactivation study for TSE agents
Annex D (informative) - Guidance on scaling down
Annex E (informative) - Statistical evaluation of virus titres
                        and reduction factors and assessment of
                        their validity
Annex F (informative) - Calculation of reduction factors
Annex G (informative) - Probability of detection of agents at
                        low concentrations
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of Directive 93/42/EEC as amended by
                         Commission Directive 2003/32/EC
Bibliography

Describes requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable.

This part of ISO22442 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO22442-1. It does not cover other transmissible and non-transmissible agents.

NOTE1 Analysis and management of risk is described in ISO22442-1. 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 transmissible spongiform encephalopathy. Selective sourcing is extremely important (see ISO22442-1 and ISO22442-2).

NOTE2 ISO11135, ISO11137, ISO11737-1, ISO13408, ISO14160, ISO14937 and ISO17665 may be relevant for bacteria, moulds and yeast (see Bibliography).

This part of ISO22442 does not cover the utilization of human tissues in medical devices.

This part of ISO22442 does not specify a quality management system for the control of all stages of production of medical devices.

NOTE3 It is not a requirement of this part of ISO22442 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 ISO13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO22442 can form part of a quality management system conforming to ISO13485.

This part of ISO22442 does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.