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AFNOR
NF EN ISO 21649 : 2009

NF EN ISO 21649 : 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Superseded date

04-04-2023

Superseded by

NF EN ISO 21649:2023

Published date

12-01-2013

Publisher

Association Francaise de Normalisation

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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)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded
SupersededBy

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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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