ANSI/AAMI/ISO 22442-1-2016 pdf download.Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
This part of 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 ISO 1 4971 , 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 1 4971 , and expected medical benefit as compared to available alternatives. This part of ISO 22442 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
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply. This part of ISO 22442 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. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 1 3485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the application of this part of ISO 22442, see Annex A.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1 0993-1 , Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
ISO 1 4971, Medical devices—Application of risk management to medical devices
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives—Part 2: Control on sourcing, collection and handling.ANSI/AAMI/ISO 22442-1 pdf download.