EN 13544-3:2001+A1:2009

Name: EN 13544-3:2001+A1:2009
Brand: CEN

Superseded

Respiratory therapy equipment - Part 3: Air entrainment devices

Superseded date

06-14-2022

Published date

09-09-2009

Publisher

Comite Europeen de Normalisation

Foreword
1 Scope
2 Normative references
3 Terms and definition
   3.1 Air entrainment device
4 Oxygen supply
5 Connections
   5.1 Oxygen supply inlet
   5.2 Air inlet attachments
6 Delivered oxygen concentration
7 Marking and identification
   7.1 Marking
   7.2 Colour coding
8 Information supplied by the manufacturer
9 Usability
10 Clinical evaluation
Annex A (normative) - Method of test for delivered oxygen
                      concentration
Annex B (informative) - Rationale
Annex C (informative) - Colour coding
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential
                         Requirements of EU Directive
                         93/42/EEC
Bibliography

This part of this European Standard specifies minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. It gives a test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device.It also specifies marking requirements and gives an optional system of colour coding to assist the user to identify the designated oxygen concentration.This standard does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.

Committee	CEN/TC 215
DevelopmentNote	2001 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (10/2009)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Superseded

Standards	Relationship
UNE-EN 13544-3:2001	Identical
ONORM EN 13544-3 : 2010	Identical
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
NBN EN 13544-3 : 2001 + A1 2009	Identical
PN EN 13544-3 : 2006 + A1 2010	Identical
NEN EN 13544-3 : 2001 + A1 2009	Identical
DIN EN 13544-3:2010-01	Identical
NF EN 13544-3 : 2002 + A1 2009	Identical
SN EN 13544-3 : 2001 + A1 2010	Identical
UNE-EN 13544-3:2001+A1:2010	Identical
BS EN 13544-3:2001+A1:2009	Identical

EN 738-1:1997/A1:2002	PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW METERING DEVICES
EN 60601-1-6:2010/A1:2015	MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
EN 62366 : 2008 AMD 1 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
BS 381C(1988) : LATEST	SPECIFICATION FOR COLOURS FOR IDENTIFICATION, CODING AND SPECIAL PURPOSES
EN ISO 4135:2001	ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
EN 980:2008	Symbols for use in the labelling of medical devices