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Drejtoria e Përgjithshme e Standardizimit
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ISO 11040-6:2019

Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

Jan 10, 2019

General information

90.93     Oct 16, 2024

ISO

ISO/TC 76

International Standard

11.040.25  

English   French  

Buying

Published

Language in which you want to receive the document.

Scope

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.
This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document.
Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11040-6:2012

NOW

PUBLISHED
ISO 11040-6:2019
90.93 Standard confirmed
Oct 16, 2024

National adoptions

Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

60.60 Standard published

DPS/KT 205 more