NF 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
30-01-2023
12-01-2013
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Symboles et abréviations
5 Exigences générales
6 Conditions d'essai
7 Préconditionnement des stylos-injecteurs
8 Réactifs et appareillage
9 Détermination de la précision de dosage
10 Absence de défauts
11 Détermination de la compatibilité électromagnétique
12 Sécurité électrique
13 Controle visuel
14 Controle de fonctionnement
15 Rapport d'essai
16 Informations fournies par le fabricant
Bibliographie
Defines requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.
| DevelopmentNote |
Indice de classement: S93-020-4PR. PR NF EN ISO 11608-4 May 2007. (05/2007) PR NF EN ISO 11608-4 March 2016. (04/2016)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
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| Status |
Superseded
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| SupersededBy |
| 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 |
| BS 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 |
| NF EN 60068 2-64 : 2008 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| NF EN 60601-1-2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| NF EN 60068 2-27 : 2009 | ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK |
| NF EN ISO 11608-1 : 2015 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
| NF EN 60068 2-30 : 2006 | ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB AND GUIDANCE: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE) |
| NF EN 60601-1-1 : 2001 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
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