EN 12342:1998+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
01-10-2014
09-09-2009
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
This European Standard specifies 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. It also applies to breathing tubes and Y-pieces supplied already assembled and to those supplied as components and assembled in accordance with the manufacturers' instructions.Provision is made for breathing tubes having ends incorporating adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered).Breathing tubes for special purposes, such as those used with ventilators having special compliance requirements and coaxial lumen tubes, are outside the scope of this European Standard.Unless specified otherwise, the requirements of this European Standard apply equally to breathing tubes intended by the manufacturer for single use and those intended for re-use.
Committee |
CEN/TC 215
|
DevelopmentNote |
1998 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (10/2009)
|
DocumentType |
Standard
|
PublisherName |
Comite Europeen de Normalisation
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
DIN EN 12342:1998-09 | Identical |
NBN EN 12342 : 1998 + A1 2009 | Identical |
NS EN 12342 : 1998 + A1 2009 | Identical |
UNE-EN 12342:1999 | Identical |
NF EN 12342 : 1998 + A1 2009 | Identical |
NEN EN 12342 : 1998 + A1 2009 | Identical |
I.S. EN 12342:1999 | Identical |
PN EN 12342 : 2006 + A1 2010 | Identical |
DIN EN 12342:2010-01 | Identical |
BS EN 12342 : 1998 | Identical |
SN EN 12342 : 1999 + A1 2010 | Identical |
UNI EN 12342 : 2009 | Identical |
UNE-EN 12342:1999+A1:2010 | Identical |
BS EN 12342:1998+A1:2009 | Identical |
12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
DIN EN 1281-1:1998-07 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS |
UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
DIN EN 794-1:2001-02 | LUNG VENTILATORS - PART 1: PARTICULAR REQUIREMENTS FOR CRITICAL CARE VENTILATORS |
I.S. EN 794-3:1998 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
UNI EN 794-3 : 2009 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
01/560291 DC : DRAFT JAN 2001 | BS EN ISO 17510-2 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
PREN ISO 15883-2 : DRAFT 2002 | WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC |
I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
BS EN 794-3 : 1999 | LUNG VENTILATORS - PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS |
BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
EN 794-3:1998+A2:2009 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
03/700194 DC : DRAFT FEB 2003 | BS EN ISO 15883-2 - WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC. |
EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
DIN EN 794-3:2009-12 | Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators; German version EN 794-3:1998+A2:2009 |
DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
UNE-EN 794-3:1999 | LUNG VENTILATORS. PART 3: PARTICULAR REQUIREMENTS FOR EMERGENCY AND TRANSPORT VENTILATORS. |
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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