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UNI EN 12342 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
Superseded date

15-01-2015

Published date

01-01-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Materials
5 Design
6 Length
7 Resistance to flow
8 Means of connection
9 Leakage
10 Increase in flow resistance with bending
11 Compliance of breathing tubes
12 Information to be supplied by the manufacturer
13 Electrical resistance
14 Requirements for breathing tubes supplied sterile
15 Marking
Annex A (normative) - Resistance to air flow
Annex B (normative) - Method of testing security of
         attachment of plain end to appropriately-sized
         male conical connector
Annex C (normative) - Method of testing security of
         attachment of adaptor to breathing tube
Annex D (normative) - Method of testing leakage
Annex E (normative) - Method of testing increase in flow
         resistance with bending
Annex F (normative) - Method of testing compliance
Annex G (informative) - Recommendations for materials
         and design
Annex H (informative) - Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Describes the basic requirements for breathing tubes and breathing tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifiers and nebulizers. Also relates to breathing tubes and Y-pieces supplied already assembled and to those supplied as components and assembled in accordance with the manufacturers' instructions.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 740:1998/A1:2004 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
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)
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 468:1982 Surface roughness — Parameters, their values and general rules for specifying requirements
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
EN 980:2008 Symbols for use in the labelling of medical devices
EN 30993-1 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS

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