NF EN ISO 15747
Plastic containers for intravenous injections
ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
Le présent document contient des exigences relatives à la manipulation sûre et aux essais physiques, chimiques et biologiques des récipients en plastique pour préparations parentérales. Il s'applique aux récipients en plastique pour préparations parentérales, munis d'une ou de plusieurs chambres et ayant une capacité nominale totale comprise entre 50 ml et 5 000 ml, tels que les poches souples en feuille de polymère ou les flacons en plastique extrudé-soufflé pour l'administration directe en perfusion (injection) des solutions. Le présent document est une norme harmonisée venant en appui à la Directive européenne 93/42/CEE sur les dispositifs médicaux.
<p>This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</p> <p>This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.</p> <p>NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.</p>
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Exigences2
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4.1 Exigences physiques2
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4.2 Exigences chimiques4
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4.3 Exigences biologiques5
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5 Identification5
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6 Application des essais5
- Annexe A (normative) Essais physiques6
- Annexe B (normative) Essais chimiques9
- Annexe C (normative) Essais biologiques12
- Bibliographie14
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