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STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

National Standards Authority of Ireland

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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
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Types of syringes
5 Requirements
6 Packaging
7 Information supplied by the manufacturer
Annex A (normative) - Fluid for determination of acidity/alkalinity
        and extractable metals
Annex B (normative) - Test method for air leakage past syringe
        piston during aspiration and for separation of rubber
        stopper and plunger
Annex C (normative) - Test method for determination of forces
        required to operate piston
Annex D (normative) - Test method for determination of
        dead space
Annex E (normative) - Test method for liquid leakage at
        syringe piston and syringe nozzle/hub or needle/barrel
        unions during compression
Annex F (normative) - Test method for air leakage past
        nozzle/hub or needle/barrel unions during aspiration
Annex G (normative) - Preparation of extract for test for
        pyrogenicity and toxicity
Annex H (normative) - Syringe sizes and graduated scales
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC amended by Directive 2007/47/EEC

Defines requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user.

DocumentType	Standard
Pages	46
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 8537:2008

Standards	Relationship
UNI EN ISO 8537 : 2008	Identical
DIN EN ISO 8537:2008-10	Identical
NEN EN ISO 8537 : 2016	Identical
EN ISO 8537:2016	Identical
UNE-EN ISO 8537:2016	Identical
BS EN ISO 8537:2016	Identical
SN EN ISO 8537 : 2016	Identical
NBN EN ISO 8537 : 2016	Identical
ISO 8537:2016	Identical
NF EN ISO 8537 : 2016	Identical
NS EN ISO 8537 : 1994	Identical
DIN EN ISO 8537:2001-03	Identical

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 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 11608-5:2012	Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
ISO 11608-1:2014	Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
EN ISO 7864:2016	Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
ISO 81714-1:2010	Design of graphical symbols for use in the technical documentation of products Part 1: Basic rules
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
EN ISO 14971:2012	Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
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 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment 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)
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

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I.S. EN ISO 8537:2016

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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