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DIN EN ISO 7886-3 E : 2010

DIN EN ISO 7886-3 E : 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION

Available format(s)

Hardcopy , PDF

Superseded date

11-04-2020

Language(s)

English

Published date

01-01-2010

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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
National Annex NA (informative) - 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
Pages
21
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

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
DIN EN ISO 9626 E : 2016 STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)
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
DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
DIN EN ISO 7886-1 E : 1997 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

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Hardcopy - English
PDF - English
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