UNI EN 13544-3 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
14-07-2022
28-10-2009
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
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Superseded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 | |
| Supersedes |
| 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 (ISO 4135:2001) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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