UNI EN ISO 7886-3 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
13-09-2022
01-01-2009
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
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)
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| 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 |
| 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 |
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