17/30336577 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
Hardcopy , PDF
English
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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
|
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| 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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