EN 13544-3:2001+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Respiratory therapy equipment - Part 3: Air entrainment devices
14-06-2022
09-09-2009
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Superseded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 (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.