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

UNI EN ISO 7886-3 : 2009

Superseded

View Superseded by

STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION

Superseded date

09-13-2022

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

Describes 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.

DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 7886-3:2021
Supersedes	UNI EN ISO 7886-3 : 2005

Standards	Relationship
I.S. EN ISO 7886-3:2009	Identical
ONORM EN ISO 7886-3 : 2010	Identical
EN ISO 7886-3:2009	Identical
NS EN ISO 7886-3 : 2009	Identical
SN EN ISO 7886-3 : 2010	Identical
NBN EN ISO 7886-3 : 2009	Identical
NEN EN ISO 7886-3 : 2009	Identical
NF EN ISO 7886-3 : 2009	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

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