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

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.

General Information

CodeClassificationThemePagesPublisherAvailability
RS ISO 11608-3: 2022ADOPTED ISO STANDARDSHealth care technology35Third Edition
Jul 2026		Available
Price: RWF 40,500


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