14/30281863 DC : 0

Superseded

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BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS

Available format(s)

Hardcopy , PDF

Superseded date

10-31-2016

Language(s)

English

Publisher

British Standards Institution

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

BS EN ISO 5364

Committee	CH/121/5
DocumentType	Draft
Pages	24
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 5364:2016

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