I.S. EN ISO 7886-4:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 4: SYRINGES WITH RE-USE PREVENTION FEATURE
Hardcopy , PDF
04-04-2019
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 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
Describes 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.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 7886-4 : 2009 | Identical |
| UNE-EN ISO 7886-4:2010 | Identical |
| ISO 7886-4:2006 | Identical |
| NF EN ISO 7886-4 : 2009 | Identical |
| EN ISO 7886-4:2009 | Identical |
| NBN EN ISO 7886-4 : 2009 | Identical |
| UNI EN ISO 7886-4 : 2009 | Identical |
| NS EN ISO 7886-4 : 2009 | Identical |
| BS EN ISO 7886-4:2009 | Identical |
| ONORM EN ISO 7886-4 : 2010 | Identical |
| SN EN ISO 7886-4 : 2010 | 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 |
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