NF EN 13544-3 : 2002 + A1 2009

Superseded

View Superseded by

RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES

Superseded date

01-13-2023

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

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Status	Superseded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	NF EN ISO 23372:2022

Standards	Relationship
BS EN 13544-3 : 2001	Identical
UNI EN 13544-3 : 2009	Identical
NS EN 13544-3 : 2001 + A1 2009	Identical
I.S. EN 13544-3:2001	Identical
ONORM EN 13544-3 : 2010	Identical
NBN EN 13544-3 : 2001 + A1 2009	Identical
UNE-EN 13544-3:2001	Identical
EN 13544-3:2001+A1:2009	Identical
NEN EN 13544-3 : 2001 + A1 2009	Identical
DIN EN 13544-3:2010-01	Identical
SN EN 13544-3 : 2001 + A1 2010	Identical

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
EN 980:2008	Symbols for use in the labelling of medical devices