I.S. EN ISO 7886-3:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
Hardcopy , PDF
30-11-2020
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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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
Defines 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
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 7886-3 : 2010 | Identical |
| UNI EN ISO 7886-3 : 2009 | 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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