I.S. EN 12181:1998
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OROPHARYNGEAL AIRWAYS
Hardcopy , PDF
English
01-01-1998
11-07-2011
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.
Dates of withdrawal of national standards are available from NSAI.
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Superseded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 |
| BS EN 12181:1998 | Identical |
| NEN EN 12181 : 1998 | Identical |
| NS EN 12181 : 1ED 1998 | Identical |
| DIN EN 12181:1998-04 | Identical |
| NBN EN 12181 : 1998 | Identical |
| NF EN 12181 : 1998 | Identical |
| EN 12181:1998 | Identical |
| UNE-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 (ISO 4135:2001) |
| 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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