UNI EN 12342 : 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
15-01-2015
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Superseded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 |
Standards | Relationship |
EN 12342:1998+A1:2009 | Identical |
NBN EN 12342 : 1998 + A1 2009 | Identical |
NS EN 12342 : 1998 + A1 2009 | Identical |
UNE-EN 12342:1999 | Identical |
DIN EN 12342:2010-01 | Identical |
BS EN 12342 : 1998 | Identical |
SN EN 12342 : 1999 + A1 2010 | Identical |
NF EN 12342 : 1998 + A1 2009 | Identical |
NEN EN 12342 : 1998 + A1 2009 | Identical |
I.S. EN 12342:1999 | Identical |
DIN EN 12342:1998-09 | Identical |
EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
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 (ISO 4135:2001) |
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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