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I.S. EN 12181:1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OROPHARYNGEAL AIRWAYS
Available format(s)

Hardcopy , PDF

Superseded date

07-11-2011

Language(s)

English

Published date

01-01-1998

Publisher

National Standards Authority of Ireland

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.

Foreword
Introduction
1 Scope
2 Normative references
3 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 end
Annex B (normative) Test method for resistance to distortion
Annex C (informative) Guidance on materials and design
Annex D (informative) Bibliography

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

DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
SN EN 12181 : 1998 Identical
BS EN 12181:1998 Identical
UNI EN 12181 : 1998 Identical
NEN EN 12181 : 1998 Identical
NS EN 12181 : 1ED 1998 Identical
DIN EN 12181:1998-04 Identical
UNE-EN 12181:1998 Identical
NBN EN 12181 : 1998 Identical
NF EN 12181 : 1998 Identical
EN 12181 : 1998 Identical

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
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 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
EN 980:2008 Symbols for use in the labelling of medical devices
EN 30993-1 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS

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Hardcopy - English
PDF - English
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