EN ISO 7886-4:2009

Name: EN ISO 7886-4:2009
Brand: CEN

Superseded

View Superseded by

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

Superseded date

03-13-2019

Published date

09-23-2009

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Types of syringe
6 Cleanliness
7 Limits for acidity or alkalinity
8 Limits for extractable metals
9 Lubricant
10 Tolerance on graduated capacity
11 Graduated scale
12 Barrel
13 Piston/plunger assembly
14 Syringe nozzle/needle
15 Performance
16 Packaging
17 Labelling
Annex A (normative) - Method for preparation of extracts
Annex B (normative) - Test method for testing re-use
                      prevention feature for RUP syringes
Annex C (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC on medical
                         devices
Bibliography

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.

Committee	CEN/TC 205
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 7886-4:2019

Standards	Relationship
I.S. EN ISO 7886-4:2019&LC:2019	Identical
NBN EN ISO 7886-4 : 2009	Identical
I.S. EN ISO 7886-4:2009	Identical
PN EN ISO 7886-4 : 2010	Identical
ISO 7886-4:2018	Identical
ISO 7886-4:2006	Identical
NF EN ISO 7886-4 : 2009	Identical
UNI EN ISO 7886-4 : 2009	Identical
NEN-EN-ISO 7886-4:2019 en	Identical
NS EN ISO 7886-4 : 2009	Identical
BS EN ISO 7886-4:2009	Identical
DIN EN ISO 7886-4 E : 2010	Identical
ONORM EN ISO 7886-4 : 2010	Identical
SN EN ISO 7886-4 : 2010	Identical
UNI EN ISO 7886-4 : 2019	Identical
NEN EN ISO 7886-4 : 2009	Identical
UNE-EN ISO 7886-4:2010	Identical
NF EN ISO 7886-4:2019	Identical
DIN EN ISO 7886-4:2010-01	Identical

ISO 7886-3:2005	Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization
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 7886-2:1996	Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
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