ISO 11608-3:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths ISO 11608-3:2022

Publication date:   Apr 7, 2022

General information

60.60 Standard published   Apr 7, 2022

ISO

ISO/TC 84 Devices for administration of medicinal products and catheters

International Standard

11.040.25   Syringes, needles and catheters

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Scope

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
—    sterile hypodermic needles;
—    sterile hypodermic syringes;
—    sterile single-use syringes, with or without needle, for insulin;
—    containers that can be refilled multiple times;
—    containers intended for dental use;
—    catheters or infusion sets that are attached or assembled separately by the user.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11608-3:2012

NOW

PUBLISHED
ISO 11608-3:2022
60.60 Standard published
Apr 7, 2022