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CEN
EN 1282-1 : 1996

EN 1282-1 : 1996

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - TUBES FOR USE IN ADULTS

Superseded date

01-07-2004

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Size designation and dimensions
5 Materials
6 Design and finish
7 Requirements for tracheostomy tubes supplied sterile
8 Marking and labelling
Annexes
A (normative) Test method for the security of attachment
    of connector and neck-plate to tracheostomy tube
B (normative) Test method for determining the resting
    diameter of the cuff
C (informative) Guidance on materials and design
D (informative) Bibliography
ZA (informative) Clauses of this European Standard
    addressing essential requirements or other provisions of
    EU Directives

Defines requirements for plastics and/or rubber tracheotomy tubes with inside diameters of 6,5 mm or larger for use with patients requiring anaesthesia, artificial ventilation or other respiratory support, but is also suitable for other applications.

Committee
CEN/TC 215
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 1282-1 : 1996 Identical
NEN EN 1282-1 : 1996 Identical
NS EN 1282-1 : 1ED 1996 Identical
SN EN 1282-1 : 1997 Identical
UNI EN 1282-1 : 1998 Identical
NF EN 1282-1 : 1997 Identical
DIN EN 1282-1:1996-12 Identical
BS EN 1282-1:1997 Identical
I.S. EN 1282-1:1997 Identical
UNE-EN 1282-1:1997 Identical

DIN EN 1733:2003-02 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 1733:2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
EN 1733 : 2002 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
BS EN 1733:2002 Suction catheters for use in the respiratory tract

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
EN 1281-1:1997/A1:1998 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - CONES AND SOCKETS
EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
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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