This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1. This document is not applicable to the following: \u2014 needles for dental use; \u2014 pre-attached syringe needles; \u2014 hypodermic needles; \u2014 needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); \u2014 materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608?3, and hypodermic needles provided separately are covered in ISO 7864.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 Symbols 5 Requirements 5.1 Needle tube requirements 5.1.1 General <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5.1.2 Needle tubing materials 5.1.3 Tubing characteristics 5.2 Double-ended pen needle requirements 5.2.1 General 5.2.2 Biocompatibility 5.2.3 Dimensions for double-ended pen needle assembly <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5.2.4 Needle points 5.2.5 Freedom from defects 5.2.6 Flow rate through the needle <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.2.7 Bond between hub and needle tube <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.2.8 Dislocation of measuring point at patient end 5.2.9 Ease of assembly 5.2.10 Sterility <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.2.11 Pyrogenicity 5.3 Functional compatibility with NISs 5.3.1 General 5.3.2 Dose delivery <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.3.3 Needle removal torque <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6 Sampling <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 7 Preconditioning of needles 7.1 Preconditioning in a dry-heat, cold storage and damp heat atmosphere 7.2 Preconditioning in a cyclical atmosphere 8 Standard atmosphere and test apparatus 8.1 Standard test atmosphere 8.2 Test gauge <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 8.3 Test apparatus 9 Test methods 9.1 Bond between hub and needle tube 9.2 Determination of dislocation of measuring point at patient end <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 9.3 Ease of assembly 9.4 Functional compatibility with NISs 9.4.1 Sample quantity requirements <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 9.4.2 Test procedures for testing dose delivery <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 9.4.3 Procedure for testing needle hub removal torque 10 Packaging 11 Information supplied with the needle(s) 11.1 General <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 11.2 Marking 11.2.1 Marking on the unit packaging <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 11.2.2 Marking on the user packaging <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 11.3 Instructions for use <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Annex A (normative) Determination of flow rate through needle <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex B (informative) Needle bonding strength test method <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Annex C (informative) Additional background for requirements <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles – Part 2: Needles<\/b><\/p>\n |