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: \u2014 sterile hypodermic needles; \u2014 sterile hypodermic syringes; \u2014 sterile single-use syringes, with or without needle, for insulin; \u2014 containers that can be refilled multiple times; \u2014 containers intended for dental use; \u2014 catheters or infusion sets that are attached or assembled separately by the user.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 4.1 General <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 4.2 Container integrity 4.2.1 Container Closure Integrity (CCI) 4.2.2 Resealability \u2014 All multi-dose cartridges or reservoirs with discs 4.2.3 Fragmentation (disc coring) \u2013 cartridges or reservoirs with discs <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4.3 Cannula requirements (as part of the fluid path) 4.3.1 Rigid needles 4.3.2 Soft cannulas 4.4 Fluid line connections 4.5 Medicinal product compatibility 4.5.1 General <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4.5.2 Medicinal product compatibility with reservoir and integrated fluid path materials 4.5.3 Reservoir and integrated fluid path particulate matter 4.5.4 Reservoir and fluid path pyrogenicity <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.5.5 Reservoir and integrated fluid path leachables 4.5.6 Sterilization of the reservoir and\/or integrated fluid path <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.6 Medicinal product leakage 5.1 Resealability for multi-dose cartridges or reservoirs <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.2 Fragmentation (disc coring) \u2013 cartridges or reservoirs <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.3 Sub-visible particulates 5.4 Visible particulates 6.1 General 6.2 Marking on the unit packaging <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Needle-based injection systems for medical use. Requirements and test methods – Containers and integrated fluid paths<\/b><\/p>\n |