Standards Development

Scope

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing human materials which are non-viable or have been rendered non-viable. The document specifies, in conjunction 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 determining the acceptability of residual risks, taking into account the risk profile and expected benefit as compared to available alternatives, in line with ISO 14971. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human materials such as:

a) contamination by bacteria, moulds, yeasts or parasites;

b) contamination by viruses;

c) contamination by agents causing transmissible spongiform encephalopathies (TSEs) and other transmissible agents;

d) material responsible for undesired pyrogenic, immunological or toxicological reactions.

This document 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.

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

NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.

NOTE 2 For guidance on the application of this document, see Annex A.

This document does not address requirements for consent to donation of human materials.