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

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

Status: Valid

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

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

Subjects

Syringes, needles and catheters (11.040.25)


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

Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015, IDT)
Subscribe on standards - Read more Dölj
Price: 1 487 SEK
standard ikon pdf

PDF

Price: 1 487 SEK
standard ikon

Paper

Price: 2 379,20 SEK
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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8020646

Edition: 1

Approved: 5/25/2016

No of pages: 68