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DIN
DIN EN ISO 5366 E : 2017

DIN EN ISO 5366 E : 2017

Current

Current

The latest, up-to-date edition.

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for TRACHEOSTOMY
  TUBES and connectors
5 Materials
6 Design requirements for TRACHEOSTOMY TUBES
  and connectors
7 Requirements for TRACHEOSTOMY TUBES supplied
  sterile
8 Information supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (normative) - Test method for the security of
        attachment of a fitted connector and NECK-PLATE to
        the TRACHEOSTOMY TUBE
Annex C (normative) - Test method for determining the
        diameter of the CUFF
Annex D (normative) - Test method for cuff herniation
Annex E (normative) - Test method for determining kink
        resistance
Annex F (informative) - Guidance on materials and design
Annex G (informative) - Hazard identification for risk
        assessment
Bibliography

Describes requirements for adult and paediatric TRACHEOSTOMY TUBES and connectors.

DevelopmentNote
Supersedes DIN EN ISO 5366-1 E and DIN EN 1282-2 E. (04/2017)
DocumentType
Standard
Pages
34
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
EN ISO 5366:2016 Identical
ISO 5366:2016 Identical

ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
DIN EN ISO 80369-7 E : 2017 SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
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
DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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Hardcopy - English
PDF - English
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