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17/30336577 DC : 0

NA
NA

Status of Standard is Unknown

BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
Available format(s)

Hardcopy , PDF

Language(s)

English

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 connectors
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 security
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

BS EN ISO 20697.

Committee
CH/84
DocumentType
Draft
Pages
45
PublisherName
British Standards Institution
Status
NA

ASTM F 1842 : 2015 : REDLINE Standard Test Method for Determining Ink or Coating Adhesion on Flexible Substrates for a Membrane Switch or Printed Electronic Device
ISO 14630:2012 Non-active surgical implants General requirements
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ASTM F 1828 : 2017 : REDLINE Standard Specification for Ureteral Stents
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 980:2008 Symbols for use in the labelling of medical devices
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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