17/30345938 DC : 0
NA
Status of Standard is Unknown
BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design Attributes
6 Materials
7 Design evaluation
8 Sterilization
9 Packaging
10 Information to be supplied by the manufacturer
Annex A (normative) - Test method for resistance to corrosion
Annex B (normative) - Determination of flowrate through catheter
Annex C (normative) - Test method for liquid leakage under pressure
Annex D (normative) - Method for determining peak tensile force
Annex E (informative) - Units of measurement systems other than
those specified in this document, which may additionally
be used
Bibliography
BS ISO 20698.
| Committee |
CH/84
|
| DocumentType |
Draft
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| DIN 13273-7:2003-08 | CATHETER FOR MEDICAL USE - PART 7: DETERMINATION OF THE X-RAY ATTENUATION OF CATHETERS - REQUIREMENTS AND TESTING |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 4788:2005 | Laboratory glassware — Graduated measuring cylinders |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| 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 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| EN 13868:2002 | Catheters - Test methods for kinking of single lumen catheters and medical tubing |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
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