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I.S. EN ISO 7886-1:1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
Available format(s)

Hardcopy , PDF

Superseded date

03-06-2018

Language(s)

English

Published date

01-01-1998

Publisher

National Standards Authority of Ireland

Preview

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.

National Foreword
European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
6 Extraneous matter
7 Lubricant
8 Tolerance on graduated capacity
9 Graduated scale
10 Barrel
11 Plunger stopper/plunger assembly
12 Nozzle
13 Performance
14 Packaging
15 Information supplied by the manufacturer
Annex A (normative) - Method for preparation
        of extracts
Annex B (normative) - Test method for air leakage
        past syringe plunger stopper during aspiration,
        and for separation of plunger stopper and plunger
Annex C (normative) - Method for determination of
        dead space
Annex D (normative) - Test method for liquid leakage
        at syringe plunger stopper under compression
Annex E (informative) - Test method for the determination
        of forces required to operate the piston
Annex F (informative) - Test method for the quantity of
        silicone
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be covered

Defines requirements for sterile single-use hypodermic plastic syringes for aspiration or injecting of fluids immediately after filling. Does not include syringes to be used with insulin, single-use glass syringes, syringes used with power-driven syringe pumps, prefilled with injection by the manufacturer or supplied as a kit for filling by a pharmacist.

DevelopmentNote
2018 edition incorporates corrigendum 2018. (05/2018)
DocumentType
Standard
Pages
39
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

EN ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
ISO 384:2015 Laboratory glass and plastics ware Principles of design and construction of volumetric instruments
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)

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Hardcopy - English
PDF - English
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