UNI EN 13544-3 : 2009

Name: UNI EN 13544-3 : 2009
Brand: UNI

Superseded

View Superseded by

RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES

Superseded date

14-07-2022

Published date

28-10-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

Describes minimum performance and safety requirements for air entrainment devices used for delivery of a designated oxygen concentration to patients. Also provides test method to check the oxygen concentration in the air/oxygen mixture generated by the air entrainment device.

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 23372:2022
Supersedes	UNI EN 13544-3 : 2003

Standards	Relationship
BS EN 13544-3 : 2001	Identical
NS EN 13544-3 : 2001 + A1 2009	Identical
I.S. EN 13544-3:2001	Identical
NBN EN 13544-3 : 2001 + A1 2009	Identical
EN 13544-3:2001+A1:2009	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
ONORM EN 13544-3 : 2010	Identical
UNE-EN 13544-3:2001	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)
EN ISO 4135:2001	ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
EN 980:2008	Symbols for use in the labelling of medical devices