Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
Abstract
ISO 7886-3:2005 specifies the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.
ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturer
ISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.
DIN EN ISO 7886-3:2010-01 (E)
Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixeddose
immunization (ISO 7886-3:200 5)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………6
5 Cleanliness …………………………………………………………………………………………………………………….7
6 Limits for acidity or alkalinity ………………………………………………………………………………………….7
7 Limits for extractable metals …………………………………………………………………………………………..7
8 Lubricant ………………………………………………………………………………………………………………………..7
9 Tolerance on nominal capacity ………………………………………………………………………………………..7
10 Graduated scale ……………………………………………………………………………………………………………..7
11 Barrel ……………………………………………………………………………………………………………………………..8
12 Piston/plunger assembly …………………………………………………………………………………………………8
13 Needle …………………………………………………………………………………………………………………………….8
14 Performance …………………………………………………………………………………………………………………..9
15 Packaging …………………………………………………………………………………………………………………….10
16 Labelling ……………………………………………………………………………………………………………………….10
Annex A (normative) Method for preparation of extracts ……………………………………………………………….13
Annex B (informative) Test method for forces required to operate plunger …………………………………….14
Annex C (normative) Test method for testing auto-disable feature …………………………………………………16
Bibliography …………………………………………………………………………………………………………………………………17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………18