NF EN ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1 : application of risk management
ISO 22442-1:2007 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. ISO 22442-1:2007 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: contamination by bacteria, moulds or yeasts; contamination by viruses; contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); material responsible for undesired pyrogenic, immunological or toxicological reactions.
ISO 22442-1:2007 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. ISO 22442-1:2007 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:
- contamination by bacteria, moulds or yeasts;
- contamination by viruses;
- contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
- material responsible for undesired pyrogenic, immunological or toxicological reactions.
Le présent document complète la norme NF EN 1441 (Dispositifs médicaux Analyse des risques) en décrivant des exigences et des conseils supplémentaires pour des dispositifs médicaux utilisant des tissus d'origine animale non viables ou rendus non viables. Les principes généraux décrits sont réputés s'appliquer à tous les virus et agents transmissibles. Ce document s'inscrit dans une norme en trois parties. La partie 2 décrit les prescriptions relatives aux contrôles de l'origine, de la collecte et du traitement des tissus animaux. La partie 3 spécifie les exigences relatives à la validation de l'élimination et/ou de l'inactivation des virus et autres agents transmissibles lors de la fabrication des dispositifs médicaux.
<p>ISO 22442-1:2015 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 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</p> <p>a) contamination by bacteria, moulds or yeasts;</p> <p>b) contamination by viruses;</p> <p>c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);</p> <p>d) material responsible for undesired pyrogenic, immunological or toxicological reactions.</p> <p>For parasites and other unclassified pathogenic entities, similar principles can apply.</p> <p>ISO 22442-1:2015 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.</p> <p>ISO 22442-1:2015 does not specify a quality management system for the control of all stages of production of medical devices.</p> <p>ISO 22442-1:2015 does not cover the utilization of human tissues in medical devices.</p> <p>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 13485) that control all stages of production or reprocessing of medical devices.</p> <p>NOTE 2 For guidance on the application of this part of ISO 22442, see Annex A.</p>
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives2
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3 Termes et définitions2
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4 Processus de gestion des risques3
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4.1 Généralités3
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4.2 Analyse du risque4
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4.3 Évaluation des risques5
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4.4 Maîtrise des risques5
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4.5 Évaluation de l'acceptabilité du risque résiduel global7
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4.6 Système d'information de production et de postproduction7
- Annexe A (informative) Directives concernant l'application de la présente partie de l'ISO 224428
- Annexe B (informative) Représentation graphique d'une partie du processus de gestion des risques pour les dispositifs médicaux utilisant un matériau d'origine animale9
- Annexe C (normative) Exigences particulières applicables à certains matériaux d'origine animale en rapport avec la gestion des risques pour les agents EST11
- Annexe D (informative) Informations relatives à la gestion du risque d'EST17
- Bibliographie26
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