ONORM EN ISO 11608-4 : 2007

Name: ONORM EN ISO 11608-4 : 2007
Brand: ON

Superseded

View Superseded by

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

Superseded date

10-27-2022

Published date

01-12-2013

Publisher

Osterreichisches Normungsinstitut/Austrian Standards

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
PublisherName	Osterreichisches Normungsinstitut/Austrian Standards
Status	Superseded
SupersededBy	ÖNORM EN ISO 11608-4:2022

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

IEC 60068-2-27:2008	Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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 60068-2-64:2008	Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
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
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 60601-1-1:2000	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60068-2-30:2005	Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)