Over deze norm
|Commissie||Biocompatibiliteit en biologisch onderzoek|
This International Standard 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 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 International Standard 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 International Standard does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such a standard except for some particular derivatives mentioned in the Annex C. This International Standard does not specify a quality management system for the control of all stages of production of medical devices. This International Standard does not cover the utilization of human tissues in medical devices.
|Nederlandse titel||Medische hulpmiddelen waarin op dierlijke weefsels en daarvan afgeleide producten zijn verwerkt - Deel 1: Toepassing van risicomanagement|
|Engelse titel||Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management|
|Vervangen door||Normatieve verwijzingen||