TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
5 Materials
6 Design and finish
7 Requirements for tracheostomy tubes supplied sterile
8 Marking
9 Adaptor
Annex A (normative) - Test for security of attachment of
        permanently attached connector, if provided, and
        neck-plate to tracheostomy tube
Annex B (normative) - Test method for determining the
        resting diameter of the cuff
Annex C (informative) - Guidance on materials and design
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC Medical devices
Bibliography

Describes requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2,0 mm to 6,0 mm.

Committee	CH/121/5
DevelopmentNote	Supersedes 94/505405 DC. (08/2005)
DocumentType	Standard
Pages	24
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 1282-2:1997

Standards	Relationship
I.S. EN 1282-2:2005	Identical
UNE-EN 1282-2:2006	Identical
SN EN 1282-2 : 2005 + A1 2010	Identical
NS EN 1282-2 : 2005 + A1 2009	Identical
EN 1282-2:2005+A1:2009	Identical
NF EN 1282-2 : 2005 + A1 2009	Identical
NEN EN 1282-2 : 2005 + A1 2009	Identical
UNI EN 1282-2 : 2009	Identical
NBN EN 1282-2 : 2005 + A1 2009	Identical
DIN EN 1282-2:2009-12	Identical

BS 7143:1989

Specification for catheter mounts (flexible adaptors) for use with medical breathing systems

EN ISO 5356-1:2015	Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
ISO 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 5366-1:2000	Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
EN ISO 5366-1:2009	Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607:2003	Packaging for terminally sterilized medical devices
ISO 5361:2016	Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO/TR 11991:1995	Guidance on airway management during laser surgery of upper airway
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
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 ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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BS EN 1282-2 : 2005

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

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