Over deze norm
|Commissie||Biocompatibiliteit en biologisch onderzoek|
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 14971, a procedure to investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control. This International Standard is intended to provide requirements and guidance on risk management related to the typical hazards 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) undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles may 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 a standard. 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||