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CAN/CSA-ISO 5364:16

Current
Current

The latest, up-to-date edition.

ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

09-01-2016

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Size designation and dimensions
5 Materials
6 Design
7 Performance requirements
8 Sterility assurance
9 Packaging of oropharyngeal airways supplied sterile
10 Marking
11 Information to be supplied by the manufacturer
Annex A (informative) - Rationale
Annex B (normative) - Test method for resistance to
        collapse of the buccal portion
Annex C (normative) - Test method for patency of lumen
Annex D (informative) - Guidance on materials and design
Bibliography

This International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.

Committee
ISO/TC 12
DocumentType
Standard
ISBN
978-1-4883-0636-5
Pages
30
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO 5364:2016 Identical

ISO 11712:2009 Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008 Symbols for use in the labelling of medical devices

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