Standard Svensk standard · SS-ISO 11040-4:2016

Förfyllda sprutor - Del 4: Sprutor i glas för injektionsläkemedel och sterila sprutor delmonterade inför fyllning (ISO 11040-4:2015, IDT)

Status: Gällande

Omfattning
This part of ISO 11040 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.
This part of ISO 11040 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 this part of ISO 11040 are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040.
NOTE Attention is drawn to applicable national or regional regulations such as Ph. Eur., USP, or JP. Where relevant, specific references to Ph. Eur., USP, and JP have been given in specific clauses or subclauses of this part of ISO 11040.

Ämnesområden

Sprutor, kanyler och katetrar (11.040.25)


Produktinformation

Språk: Engelska

Framtagen av: Förbrukningsmaterial inom sjukvården, SIS/TK 330

Internationell titel: Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015, IDT)

Artikelnummer: STD-8020646

Utgåva: 1

Fastställd: 2016-05-25

Antal sidor: 68