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DIN EN ISO 8836 E : 2015

Current
Current

The latest, up-to-date edition.

SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for open and closed
   suction catheters
5 Specific requirements for open and closed
   suction catheters
6 Materials
7 Design
8 Performance requirements
9 Requirements for suction catheters supplied sterile
10 Marking
Annex A (informative) - Rationale
Annex B (normative) - Test method for security of
        attachment
Annex C (normative) - Measurement of residual
        vacuum
Annex D (normative) - Method of testing leakage
Annex E (informative) - Hazard identification for
        risk assessment
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography

Defines requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.

DevelopmentNote
Supersedes DIN EN 1733 E. (09/2008)
DocumentType
Standard
Pages
38
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

Standards Relationship
ISO 8836:2014 Identical
EN ISO 8836:2014 Identical

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ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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