BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 General requirements
6 Specific requirements
7 Information to be supplied by the manufacturer
Annex A (normative) - Test method for determining
        the strength of the catheter
Annex B (normative) - Test method for determining
        the security of fit of the drainage funnel
Annex C (normative) - Test method for determining
        balloon security
Annex D (normative) - Test method for determining
        inflation lumen leakage and/or function and/or
        balloon deflation (catheter with compliance
        balloon)
Annex E (normative) - Test method for determination
        of flow rate through catheter
Annex F (normative) - Test method for corrosion
        resistance
Annex G (normative) - Test method for determining
        kink stability
Annex H (normative) - Test method for determining
        peak tensile force of urethral catheter
Annex I (normative) - Test method for determining
        balloon size deflation reliability
        (catheter with non-compliant balloon)
Annex J (normative) - Test method for determining
        inflated balloon resistance to traction
Bibliography

BS EN ISO 20696.

Committee	CH/84
DocumentType	Draft
Pages	41
PublisherName	British Standards Institution
Status	NA

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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
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 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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