Norm

ISO/DIS 20698:2017 en

Catheter systems for neuraxial application - Sterile and single-use catheters and accessories

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Over deze norm

Status Ontwerp
Aantal pagina's 19
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 25-03-2017
Taal Engels
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 compliance 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.

Details

ICS-code 11.040.25
Nederlandse titel Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
Engelse titel Catheter systems for neuraxial application - Sterile and single-use catheters and accessories

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