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 | ||||||
|---|---|---|---|---|---|---|---|
| 54<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | 4 Requirements 4.1 General <\/td>\n<\/tr>\n | ||||||
| 67<\/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 | ||||||
| 68<\/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 | ||||||
| 69<\/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 | ||||||
| 70<\/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 | ||||||
| 71<\/td>\n | 4.6 Medicinal product leakage 5 Test methods 5.1 Resealability for multi-dose cartridges or reservoirs <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | 5.2 Fragmentation (disc coring) \u2013 cartridges or reservoirs <\/td>\n<\/tr>\n | ||||||
| 73<\/td>\n | 5.3 Sub-visible particulates 5.4 Visible particulates 6 Information supplied with the container 6.1 General 6.2 Marking on the unit packaging <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | Annex A (informative) Medicinal product compatibility references \u2013 Requirements, guidance, standards or compendia material <\/td>\n<\/tr>\n | ||||||
| 77<\/td>\n | Annex B (informative) Historical references to previous editions <\/td>\n<\/tr>\n | ||||||
| 80<\/td>\n | Annex C (informative) Theoretical support for resealability requirements <\/td>\n<\/tr>\n | ||||||
| 83<\/td>\n | Annex D (informative) Reservoir and integrated fluid path leachables <\/td>\n<\/tr>\n | ||||||
| 85<\/td>\n | Annex E (informative) Medicinal product compatibility <\/td>\n<\/tr>\n | ||||||
| 87<\/td>\n | Annex F (informative) Primary container closure as compared to reservoir and fluid path <\/td>\n<\/tr>\n | ||||||
| 90<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods – Containers and integrated fluid paths<\/b><\/p>\n |