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.
Ciclo de vida
-
Anteriormente
RetiradaISO 11040-4:2007
-
Ahora
-
00
Preliminar
-
10
Propuesta
-
20
Preparación
-
30
Comité
-
40
Consulta
-
50
Aprobación
-
60
Publicación
-
90
Revisión
-
95
Retirada
Modificaciones
Aportan contenido adicional; disponible para su compra; no incluidas en el texto de la norma existente.RetiradaISO 11040-4:2015/Amd 1:2020
-
00
-
Revisada por
PublicadoISO 11040-4:2024