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NF EN 13544-3 : 2002 + A1 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES

Superseded date

13-01-2023

Superseded by

NF EN ISO 23372:2022

Published date

12-01-2013

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Avant-propos
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Alimentation d'oxygène
5 Raccordements
   5.1 Orifice d'alimentation en oxygène
   5.2 Pièces intermédiaires d'arrivée d'air
6 Concentration d'oxygène administrée
7 Marquage et identification
   7.1 Marquage
   7.2 Code couleur
8 Informations fournies par le fabricant
9 Aptitude à l'emploi
10 Évaluation clinique
Annexe A (normative) - Méthodes d'essai pour la concentration
         d'oxygène administrée
   A.1 Appareillage
   A.2 Mode opératoire
Annexe B (informative) - Exposé des motifs
Annexe C (informative) - Code couleur
Annexe ZA (informative) - Relation entre la présente
          Norme européenne et les exigences essentielles
          de la Directive européenne 93/42/CEE
Bibliographie

Describes minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients.

DevelopmentNote
Indice de classement: S95-180-3. (01/2002) 2002 Edition Re-issued in November 2009 & incorporates AMD 1 2009. (11/2009)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Superseded
SupersededBy

EN 738-1:1997/A1:2002 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
EN 980:2008 Symbols for use in the labelling of medical devices

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