Resumen
ISO 11040-4:2015 applies to
- tubing-glass barrels (single-chamber design) for injection preparations, and
- sterilized subassembled syringes ready for filling.
It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
ISO 11040-4:2015 also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4:2015 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.
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Informaciones generales
Ciclo de vida
-
Anteriormente
RetiradaISO 11040-4:2007
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Ahora
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00
Preliminar
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10
Propuesta
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20
Preparación
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30
Comité
-
40
Consulta
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50
Aprobación
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60
Publicación
-
90
Revisión
-
95
Retirada
Correcciones / Modificaciones
PublicadoISO 11040-4:2015/Amd 1:2020
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00
-
Será reemplazada por
En desarrolloISO/FDIS 11040-4
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