17/30336573 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
Hardcopy , PDF
English
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.