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BS EN ISO 7886-3:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Auto-disable syringes for fixed-dose immunization

Available format(s)

Hardcopy , PDF

Superseded date

05-27-2020

Language(s)

English

Published date

11-30-2009

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

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.

Committee
CH/84
DevelopmentNote
Supersedes 03/113406 DC. (01/2006)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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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