DIN EN 12342:1998-09

Name: DIN EN 12342:1998-09
Brand: DIN

Superseded

View Superseded by

BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS

Available format(s)

Hardcopy , PDF

Superseded date

01-02-2015

Language(s)

English

Published date

01-01-1998

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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.

DevelopmentNote	A transition period, as set out in DIN EN ISO 5367 E issue 02-2015 exists until 31-10-2017. (02/2015)
DocumentType	Standard
Pages	24
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 5367 E : 2015

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
NF EN 12342 : 1998 + A1 2009	Identical
NEN EN 12342 : 1998 + A1 2009	Identical
I.S. EN 12342:1999	Identical
BS EN 12342 : 1998	Identical
SN EN 12342 : 1999 + A1 2010	Identical
UNI EN 12342 : 2009	Identical

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