I.S. EN ISO 7886-3:2009
Withdrawn
View Superseded by
STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
Hardcopy , PDF
English
01-01-2009
11-30-2020
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.
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Withdrawn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 |
| EN ISO 7886-3:2009 | Identical |
| NS EN ISO 7886-3 : 2009 | Identical |
| NBN EN ISO 7886-3 : 2009 | Identical |
| NEN EN ISO 7886-3 : 2009 | Identical |
| NF EN ISO 7886-3 : 2009 | Identical |
| DIN EN ISO 7886-3:2010-01 | Identical |
| ISO 7886-3:2005 | Identical |
| BS EN ISO 7886-3:2009 | Identical |
| UNE-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 |
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