UNI EN 13544-2 : 2009
Current
The latest, up-to-date edition.
RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
28-10-2009
Foreword
1 Scope
2 Normative references
3 Nipples
3.1 Dimensions
3.2 Performance
4 Weight-bearing screw-threaded connectors
5 Tubing
5.1 General
6 Marking of tubing, labels and packaging
7 Packaging
8 Usability
9 Clinical evaluation
Annex A (normative) - Test methods
A.1 Apparatus
A.2 Method of test for strength of nipple
A.3 Method of test for resistance to gas flow of tubing
A.4 Method of test for security of connection between end
connector and tubing
A.5 Method of test for security of connection of end
connectors and nipple
A.6 Method of test for resistance to kinking
Annex B (normative) - Weight-bearing screw-threaded connectors
for oxygen and air
Annex C (informative) - Information on method of testing
security of connections
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Describes requirements for tubing to be used with equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice including the interface to the equipment i.e. nipples and screw threaded connectors.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN 13544-2 : 2002 | Identical |
| EN 13544-2:2002+A1:2009 | Identical |
| DIN EN 13544-2:2010-01 | Identical |
| NF EN 13544-2 : 2003 + A1 2009 | Identical |
| SN EN 13544-2 : 2002 + A1 2010 | Identical |
| I.S. EN 13544-2:2002 | Identical |
| NS EN 13544-2 : 2002 + A1 2009 | Identical |
| NBN EN 13544-2 : 2002 + A1 2009 | Identical |
| NEN EN 13544-2 : 2002 + A1 2009 | Identical |
| UNE-EN 13544-2:2003 | Identical |
| UNI 11341 : 2010 | BUBBLING HUMIDIFIERS FOR MEDICAL USE - FUNDAMENTAL REQUIREMENTS |
| EN 13220 : 1998 | FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
| 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 10651-4:2009 | Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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