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.
SDO | ISO: International Organization for Standardization |
Document Number | ISO 11608 |
Publication Date | Not Available |
Language | en - English |
Page Count | |
Revision Level | |
Supercedes | |
Committee | ISO/TC 84 |