UNE-EN ISO 11608-4:2008
Superseded
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006)
Hardcopy , PDF
Spanish, Castilian, English
02-27-2008
07-01-2022
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 |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| NF EN ISO 11608-4 : 2007 | Identical |
| DIN EN ISO 11608-4:2016-03 (Draft) | Identical |
| NEN EN ISO 11608-4 : 2008 | Identical |
| NS EN ISO 11608-4 : 1ED 2007 | Identical |
| I.S. EN ISO 11608-4:2007 | Identical |
| EN ISO 11608-4:2007 | Identical |
| ISO 11608-4:2006 | Identical |
| NBN EN ISO 11608-4 : 2007 | Identical |
| BS EN ISO 11608-4:2007 | Identical |