NF EN ISO 21649 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
04-04-2023
12-01-2013
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Symboles et termes abrégés
5 Exigences
6 Méthodes d'essai
7 Rapport d'essai
8 Informations fournies par le fabricant
Annexe A (informative) - Facteurs de limites de dispersion
bilatéraux (k)
Annexe B (informative) - Exemples de calcul des limites
d'exactitude et sélections aléatoires
Annexe C (informative) - Correspondance entre les normes
ISO/CEI et les normes EN
Annexe ZA (informative) - Relation entre la présente Norme
internationale et les exigences essentielles de
la Directive UE 93/42/CEE
Bibliographie
Applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.
| DevelopmentNote |
Indice de classement: S93-021. PR NF EN ISO 21649 December 2003. (12/2003) PR NF EN ISO 21649 July 2009. (07/2009)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ONORM EN ISO 21649 : 2010 | Identical |
| UNE-EN ISO 21649:2010 | Identical |
| NEN EN ISO 21649 : 2009 | Identical |
| SN EN ISO 21649 : 2010 | Identical |
| EN ISO 21649:2009 | Identical |
| ISO 21649:2006 | Identical |
| NS EN ISO 21649 : 2009 | Identical |
| NBN EN ISO 21649 : 2009 | Identical |
| I.S. EN ISO 21649:2009 | Identical |
| BS EN ISO 21649:2009 | Identical |
| DIN EN ISO 21649:2010-01 | Identical |
| ISO 11202:2010 | Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 14253-1:2017 | Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
| 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 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| ISO 3746:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane |
| 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 |
| ISO 11201:2010 | Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections |
| ISO 11204:2010 | Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
| 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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