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

Standard No.

ISO 11608-3:2022

Release Date

2022

Published By

International Organization for Standardization (ISO)

Latest

ISO 11608-3:2022

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.

ISO 11608-3:2022 Referenced Document

• ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
• ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
• ISO 11040-4 Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling — Amendment 1
• ISO 11040-5 Prefilled syringes - Part 5: Plunger stoppers for injectables
• ISO 11040-6 Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
• ISO 11040-8 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 11608-1:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
• ISO 13926-1 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use
• ISO 13926-2 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use
• ISO 13926-3 Pen systems — Part 3: Seals for pen-injectors for medical use
• ISO 21881 Sterile packaged ready for filling glass cartridges
• ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
• ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 8872 Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials — General requirements and test methods*， 2022-11-15 Update
• ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

ISO 11608-3:2022 history

• 2022 ISO 11608-3:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
• 2012 ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
• 2000 ISO 11608-3:2000 Pen-injectors for medical use - Part 3: Finished cartridges; Requirements and test methods