Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
Abstract
ISO 7886-4:2006 specifies requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
ISO 7886-4:2006 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in ISO 7886-4:2006.
NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with ISO 7886-4:2006 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in ISO 7886-4:2006.
DIN EN ISO 7886-4:2010-01 (E)
Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention
feature (ISO 7886-4:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………6
5 Types of syringe ……………………………………………………………………………………………………………..6
6 Cleanliness …………………………………………………………………………………………………………………….6
7 Limits for acidity or alkalinity ………………………………………………………………………………………….6
8 Limits for extractable metals …………………………………………………………………………………………..6
9 Lubricant ………………………………………………………………………………………………………………………..8
10 Tolerance on graduated capacity …………………………………………………………………………………….8
11 Graduated scale ……………………………………………………………………………………………………………..8
12 Barrel ……………………………………………………………………………………………………………………………..8
13 Piston/plunger assembly …………………………………………………………………………………………………8
14 Syringe nozzle/needle ……………………………………………………………………………………………………..9
15 Performance …………………………………………………………………………………………………………………..9
16 Packaging …………………………………………………………………………………………………………………….10
17 Labelling ……………………………………………………………………………………………………………………….10
Annex A (normative) Method for preparation of extracts ……………………………………………………………….13
Annex B (normative) Test method for testing re-use prevention feature for RUP syringes ……………..14
Annex C (informative) Environmental aspects ………………………………………………………………………………15
Bibliography …………………………………………………………………………………………………………………………………16
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………17