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I.S. EN ISO 5364:2016

Current
Current

The latest, up-to-date edition.

ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC

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

DevelopmentNote
Supersedes I.S. EN 12181. (07/2011)
DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
ISO 5364:2016 Identical
EN 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
EN 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
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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