NF EN ISO 17664-2
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Analyse du risque
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5 Validation des procédés identifiés dans les informations fournies par le fabricant du dispositif médical
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6 Informations à fournir par le fabricant du dispositif médical
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7 Présentation des informations
- A Méthodes de traitement couramment utilisées
- B Exemples d'instructions de traitement pour les dispositifs médicaux réutilisables non critiques
- C Classification des traitements et groupes de dispositifs médicaux
- D Recommandations supplémentaires concernant les informations à fournir par le fabricant du dispositif médical
- E Exemples de dispositifs médicaux et leur relation avec le présent document
- ZA Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
- Bibliographie
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