I.S. EN ISO 11608-4:2007

Superseded

PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS

Available format(s)

Hardcopy , PDF

Superseded date

21-06-2022

Language(s)

English

Published date

01-01-2007

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.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements
6 Test conditions
7 Preconditioning of pen-injectors
8 Reagent and apparatus
9 Determination of dose accuracy
10 Freedom from defects
11 Determination of electromagnetic compatibility
12 Electrical safety
13 Visual inspection
14 Functional inspection
15 Test report
16 Information supplied by the manufacturer
Bibliography

Defines requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.

DocumentType	Standard
Pages	22
PublisherName	National Standards Authority of Ireland
Status	Superseded
SupersededBy	I.S. EN ISO 11608-4:2022

Standards	Relationship
DIN EN ISO 11608-4:2016-03 (Draft)	Identical
NF EN ISO 11608-4 : 2007	Identical
ISO 11608-4:2006	Identical
UNE-EN ISO 11608-4:2008	Identical
NBN EN ISO 11608-4 : 2007	Identical
NEN EN ISO 11608-4 : 2008	Identical
NS EN ISO 11608-4 : 1ED 2007	Identical
SN EN ISO 11608-4 : 2007	Identical
BS EN ISO 11608-4:2007	Identical
EN ISO 11608-4:2007	Identical
ONORM EN ISO 11608-4 : 2007	Identical

IEC 60068-2-27:2008	Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
IEC 61000-4-1:2006	Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60721-3-7:1995+AMD1:1996 CSV	Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
ISO 11608-1:2014	Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
IEC 60601-1-8:2006+AMD1:2012 CSV	Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 60068-2-64:2008	Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
ISO 11608-2:2012	Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO 11608-3:2012	Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV	Degrees of protection provided by enclosures (IP Code)
IEC 61000-4-2:2008	Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV	Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 60601-1-1:2000	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
IEC 60068-2-30:2005	Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

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I.S. EN ISO 11608-4:2007

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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