ONORM EN ISO 7886-4 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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 4: SYRINGES WITH RE-USE PREVENTION FEATURE
15-06-2019
12-01-2013
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 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
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| NEN EN ISO 7886-4 : 2009 | Identical |
| UNE-EN ISO 7886-4:2010 | Identical |
| ISO 7886-4:2006 | Identical |
| EN ISO 7886-4:2019 | Identical |
| NF EN ISO 7886-4 : 2009 | Identical |
| EN ISO 7886-4:2009 | Identical |
| NBN EN ISO 7886-4 : 2009 | Identical |
| I.S. 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 |
| SN EN ISO 7886-4 : 2010 | Identical |
| DIN EN ISO 7886-4:2010-01 | Identical |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 780:2015 | Packaging Distribution packaging Graphical symbols for handling and storage of packages |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
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