BS ISO 20698:2018 - Catheter Systems for Neuraxial Application

Introducing the BS ISO 20698:2018, a comprehensive standard that sets the benchmark for catheter systems designed for neuraxial applications. This standard is essential for healthcare professionals and manufacturers who are committed to ensuring the highest level of safety and efficacy in medical procedures involving neuraxial catheters. Released on July 27, 2018, this document is a critical resource for understanding the specifications and requirements for sterile and single-use catheters and their accessories.

Key Features of BS ISO 20698:2018

• Standard Number: BS ISO 20698:2018
• Pages: 30
• Release Date: 2018-07-27
• ISBN: 978 0 580 95174 9
• Status: Standard

Comprehensive Coverage

This standard provides a detailed framework for the design, production, and testing of catheter systems intended for neuraxial applications. It covers a wide range of aspects, including material specifications, performance requirements, and safety considerations. By adhering to the guidelines set forth in BS ISO 20698:2018, manufacturers can ensure that their products meet the rigorous demands of medical professionals and provide optimal patient outcomes.

Ensuring Safety and Efficacy

Safety is paramount in medical procedures, and the BS ISO 20698:2018 standard emphasizes the importance of using sterile and single-use catheters to minimize the risk of infection and cross-contamination. The standard outlines the necessary sterilization processes and quality control measures that must be implemented to ensure that each catheter system is safe for use in sensitive neuraxial procedures.

Designed for Neuraxial Applications

Neuraxial applications require precision and reliability, and the catheter systems covered by this standard are specifically designed to meet these needs. Whether used in epidural, spinal, or combined spinal-epidural procedures, these catheter systems are engineered to provide consistent performance and ease of use, allowing healthcare professionals to focus on delivering the best possible care to their patients.

Single-Use for Enhanced Hygiene

The BS ISO 20698:2018 standard mandates the use of single-use catheters, which are crucial in maintaining high hygiene standards in medical settings. Single-use catheters eliminate the risk of cross-contamination between patients, ensuring that each procedure is conducted with the utmost care and attention to patient safety.

Comprehensive Documentation

With 30 pages of in-depth information, the BS ISO 20698:2018 standard provides a thorough understanding of the requirements for neuraxial catheter systems. This document serves as an invaluable reference for manufacturers, healthcare providers, and regulatory bodies, offering clear guidance on the production and use of these critical medical devices.

Global Recognition

As an internationally recognized standard, BS ISO 20698:2018 is widely accepted and respected in the medical community. Compliance with this standard demonstrates a commitment to quality and safety, enhancing the reputation of manufacturers and instilling confidence in healthcare providers and patients alike.

Conclusion

The BS ISO 20698:2018 standard is an essential resource for anyone involved in the production or use of catheter systems for neuraxial applications. By adhering to the guidelines outlined in this document, manufacturers can ensure that their products meet the highest standards of safety and performance, ultimately contributing to better patient care and outcomes. Whether you are a healthcare professional, a manufacturer, or a regulatory body, this standard is a vital tool in your efforts to maintain excellence in medical practice.

BS ISO 20698:2018

• 11.040.25 Syringes, needles and catheters

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.