NEN EN ISO 11608-4 : 2008
Current
The latest, up-to-date edition.
PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
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.
| DevelopmentNote |
Supersedes NEN ISO 11608-4. (02/2008)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11608-4 : 2007 | Identical |
| ISO 11608-4:2006 | Identical |
| SN EN ISO 11608-4 : 2007 | Identical |
| I.S. EN ISO 11608-4:2007 | Identical |
| DIN EN ISO 11608-4:2016-03 (Draft) | Identical |
| NF EN ISO 11608-4 : 2007 | Identical |
| UNE-EN ISO 11608-4:2008 | Identical |
| EN ISO 11608-4:2007 | Identical |
| BS EN ISO 11608-4:2007 | Identical |
| NS EN ISO 11608-4 : 1ED 2007 | Identical |
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