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UNI EN 13544-2 : 2009

Current
Current

The latest, up-to-date edition.

RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
Published date

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

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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