UNI EN ISO 5364 : 2011

Name: UNI EN ISO 5364 : 2011
Brand: UNI

Superseded

View Superseded by

ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS

Superseded date

15-09-2022

Published date

01-01-2011

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
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 (normative) - Test method for resistance to
collapse of the buccal portion
Annex B (normative) - Test method for patency of lumen
Annex C (informative) - Guidance on materials and design
Bibliography

Describes 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 UNI EN 12181. (09/2011)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5364:2016
Supersedes	UNI EN 12181 : 1998

Standards	Relationship
EN ISO 5364:2016	Identical
ISO 5364:2016	Identical

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 980:2008	Symbols for use in the labelling of medical devices