NF EN ISO 15747
Plastics containers for intravenous injection
ISO 15747:2003 contains requirements related to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. ISO 15747:2003 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range from 50 ml to 5000 ml, such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
ISO 15747:2003 contains requirements related to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2003 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range from 50 ml to 5000 ml, such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
<p>ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.</p> <p>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.</p>
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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 biologiques4
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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
- Annexe D (informative) Autres essais biologiques15
- Bibliographie16
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