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Standards Development
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable.
The document specifies, in junction 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.
This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human 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 document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This project was accepted on ISO level and it is suggested to develop the standard under Vienna Agreement.
Market need: The standard will be used by manufacturers of medical devices utilizing non-viable human material worldwide. In the US, Japan, Australia, Korea and China products are under development or already on the market that use this type of material. In the European Union such a document will be an indispensable tool to provide evidence for conformity with the general safety and performance requirements of the medical device regulation (EU) 2017/745
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