BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES

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 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