Name: EN ISO 7886-3:2009
Brand: CEN

EN ISO 7886-3:2009

Superseded

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

Superseded date

05-28-2020

Published date

09-23-2009

Publisher

Comite Europeen de Normalisation

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.

Committee	CEN/TC 205
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 7886-3:2020

Standards	Relationship
ONORM EN ISO 7886-3 : 2010	Identical
NEN EN ISO 7886-3 : 2009	Identical
NF EN ISO 7886-3 : 2009	Identical
SS-EN ISO 7886-3 : 2009	Identical
UNI EN ISO 7886-3 : 2009	Identical
NS EN ISO 7886-3 : 2009	Identical
NBN EN ISO 7886-3 : 2009	Identical
PN EN ISO 7886-3 : 2010	Identical
UNE-EN ISO 7886-3:2010	Identical
DIN EN ISO 7886-3:2010-01	Identical
ISO 7886-3:2005	Identical
BS EN ISO 7886-3:2009	Identical
DIN EN ISO 7886-3 E : 2010	Identical
I.S. EN ISO 7886-3:2009	Identical
SN EN ISO 7886-3 : 2010	Identical

ISO 8537:2016	Sterile single-use syringes, with or without needle, for insulin
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 7886-1:2017	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 780:2015	Packaging Distribution packaging Graphical symbols for handling and storage of packages
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols