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DIN EN ISO 7886-4 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 4: SYRINGES WITH RE-USE PREVENTION FEATURE
Available format(s)

Hardcopy , PDF

Superseded date

08-03-2019

Language(s)

English

Published date

01-01-2010

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
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
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on medical devices

Describes requirements for sterile single-use hypodermic syringes made of plastics 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
21
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

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
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
DIN EN ISO 780 E : 2016 PACKAGING - DISTRIBUTION PACKAGING - GRAPHICAL SYMBOLS FOR HANDLING AND STORAGE OF PACKAGES (ISO 780:2015)
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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PDF - English
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