Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 General requirements
6 Specific requirements
7 Information supplied by the manufacturer
Annex A (informative) - Test method for determining kink
        stability
Annex B (normative) - Test method for corrosion resistance
Annex C (normative) - Test method for resistance to
        deformation by suction
Annex D (normative) - Test method for determining peak
        tensile force of connections
Annex E (normative) - Test method for determining peak
        tensile force of drainage catheter
Annex F (normative) - Test method for impact resistance
        of collection device
Annex G (normative) - Test method for determination of
        flow rate through catheter
Annex H (informative) - Test method for retention strength
Annex I (normative) - Test method for determining balloon
        safety
Annex J (normative) - Test method for determining inflation
        lumen leakage and/or function and/or balloon deflation
        (catheter with compliant balloon)
Annex K (normative) - Test method for determining balloon
        size and deflation reliability (catheter with non-compliant
        balloon)
Annex L (normative) - Test method for determining inflated
        balloon resistance to traction
Annex M (normative) - Test method for resistance to leakage
        during aspiration or vacuum
Bibliography

Abstract

Describes requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 84