ONORM EN ISO 11608-4 : 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
27-10-2022
12-01-2013
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Superseded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 |
| 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) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.