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  • BSI
    BS ISO 20698:2018 Catheter systems for neuraxial application. Sterile and single-use catheters and accessories
    Edition: 2018
    $411.69
    / user per year

Description of BS ISO 20698:2018 2018

This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications.

This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements.

Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to deliver wound infiltration analgesia and to other regional analgesia procedures or to monitor or remove fluids from neuraxial sites for therapeutic or diagnostic purposes.

NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space and the epi-, extra-, or peri-dural space (applications mentioned are just examples and not an exhaustive list). In neuraxial application, anaesthetics/analgesics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the brachial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.

NOTE 2 Local anaesthesia/analgesia injected hypodermically and systemic injection of anaesthetics are not considered neuraxial applications.

This document is applicable to the following types of devices:

  • spinal/epidural catheter systems;

  • spinal/epidural port catheter systems;

  • peripheral nerve block catheter systems;

  • wound infusion catheter systems (also known as catheters for Surgical Site Continuous Analgesia).

This document is not applicable to:

  • pumps and other devices intended to deliver medications through these catheter systems;

  • catheters generically intended to administer substances into the body which are not intended to interact directly with the nervous system, but which have an indirect effect on nervous system (e.g. cannula needles);

  • drainage catheters for any other application than neuraxial.



Standard NumberBS ISO 20698:2018
TitleCatheter systems for neuraxial application. Sterile and single-use catheters and accessories
StatusDefinitive
Publication Date2018-07-27
Identical National Standard OfISO 20698:2018
DescriptorsDesign, Test methods, Accessories, Sterile equipment, Catheters
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 580 95174 9
PublisherBSI
Pages30

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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