BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 Requirements and test methods for electronic and electromechanical pen-injectors
Hardcopy , PDF
21-07-2022
English
28-09-2007
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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.
| Committee |
CH/84
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
This part of ISO11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The injector may be for single-use or multiple-use. The injector system is intended to deliver medication to an end-user by self-administration or with assistance.
This part of ISO11608 is neither applicable for needle-free injectors (as covered in ISO21649) nor infusion pumps (as covered in IEC60601-2-24).
This part of ISO11608 is not applicable for devices that are capable of operating while connected to an external power supply.
| Standards | Relationship |
| ONORM EN ISO 11608-4 : 2007 | Identical |
| NS EN ISO 11608-4 : 1ED 2007 | Identical |
| I.S. EN ISO 11608-4:2007 | Identical |
| DIN EN ISO 11608-4:2016-03 (Draft) | Identical |
| UNE-EN ISO 11608-4:2008 | Identical |
| ISO 11608-4:2006 | Identical |
| SN EN ISO 11608-4 : 2007 | Identical |
| NF EN ISO 11608-4 : 2007 | Identical |
| NEN EN ISO 11608-4 : 2008 | Identical |
| 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 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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