EN ISO 7886-3:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Cleanliness
6 Limits for acidity or alkalinity
7 Limits for extractable metals
8 Lubricant
9 Tolerance on nominal capacity
10 Graduated scale
11 Barrel
12 Piston/plunger assembly
13 Needle
14 Performance
15 Packaging
16 Labelling
Annex A (normative) Method for preparation of extracts
Annex B (informative) Test method for forces required
         to operate plunger
Annex C (normative) Test method for testing auto-disable
         feature
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on medical devices
Bibliography

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 manufacturerISO 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.