15/30273269 DC : 0

Superseded

BS EN ISO 5366 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART: TUBES AND CONNECTORS FOR USE IN ADULTS

Available format(s)

Hardcopy , PDF

Superseded date

11-30-2016

Language(s)

English

Publisher

British Standards Institution

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 Marking and labelling
Annex A (informative) - Rationale
Annex B (normative) - Test method for the security
        of attachment of a fitted connector and
        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 leakage past
        the CUFF
Annex F (normative) - Test method for determining
        kink resistance
Annex G (informative) - Guidance on materials and design
Annex H (informative) - Hazard identification for risk assessment
Bibliography
Annex ZA (informative) - Relationship between this
        document and the Essential Requirements
        EU Directive 93/42/EEC

BS EN ISO 5366.

Committee	CH/121/5
DocumentType	Draft
Pages	40
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 5366:2016

ASTM F 2503 : 2013 : REDLINE	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ASTM F 2052 : 2015 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO/TR 11991:1995	Guidance on airway management during laser surgery of upper airway
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
ASTM F 640 : 2012 : REDLINE	Standard Test Methods for Determining Radiopacity for Medical Use