Resumen
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
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.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.
Informaciones generales
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Estado: En desarrollo
Puede contribuir al desarrollo del borrador de esta norma internacional. Para ello, contacte con su miembro nacional
Etapa: Voto sobre el DIS iniciado: 12 semanas [40.20] -
Edición: 4Número de páginas: 20
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Comité Técnico :ISO/TC 76ICS :11.040.20
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Ciclo de vida
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Anteriormente
PublicadoISO 15747:2018
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Ahora