ISO 20698-2018 PDF

Full title and description

Catheter systems for neuraxial application — Sterile and single-use catheters and accessories. This international standard specifies general requirements and test methods for sterile, single‑use catheter systems intended for neuraxial applications (spinal, epidural, peripheral nerve block, wound infusion and related neuraxial uses).

Abstract

This document defines intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and the tests required to demonstrate conformity for catheter systems used in neuraxial applications. It applies to spinal/epidural catheter systems, ported catheter systems, peripheral nerve block catheter systems and wound infusion catheter systems, and it excludes pumps and other delivery devices and catheters not intended for neuraxial use.

General information

• Status: Published (confirmed as current following ISO review).
• Publication date: 2018-07-26 (Edition 1, July 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 1 (2018).
• Number of pages: 20.

Scope

Specifies requirements and test methods for sterile, single‑use catheter systems intended for neuraxial applications including spinal and epidural catheters, spinal/epidural port catheter systems, peripheral nerve block catheter systems and wound infusion catheter systems. Excludes pumps and delivery devices, general drainage catheters for non‑neuraxial use and catheters not intended to interact directly with the nervous system.

Key topics and requirements

• Intended performance and clinical functional requirements for neuraxial catheter systems.
• Design and material requirements to ensure biocompatibility and safe interaction with neuraxial tissues.
• Design evaluation and verification testing (mechanical, dimensional, flow, leak, and connection integrity).
• Sterilization, packaging and shelf‑life considerations for single‑use sterile devices.
• Labelling, instructions for use and information the manufacturer must supply (indications, contraindications, warnings).
• Exclusions and interfaces with related medical devices (e.g., pumps are out of scope; connection standards may apply separately).

Typical use and users

Used by medical device manufacturers (design, R&D, quality and regulatory teams) to develop and document catheter systems for neuraxial use; by clinical engineers and procurement specialists evaluating product conformity; and by regulatory authorities and notified bodies as a reference for conformity assessment and premarket documentation. Clinicians (anesthesiologists, pain specialists, surgical teams) use the standard indirectly through compliant products and labeling.

Related standards

Standards often referenced together with ISO 20698 include other catheter and medical connector standards such as ISO 20697 (sterile drainage catheters and accessory devices for single use) and standards from the ISO 80369 series (small-bore connectors for liquids and gases in healthcare) as well as general medical device standards addressing biocompatibility and risk management.

Keywords

neuraxial, spinal catheter, epidural catheter, peripheral nerve block, wound infusion catheter, sterile, single‑use, catheter system, medical device, ISO 20698

FAQ

Q: What is this standard?

A: ISO 20698:2018 is an international standard that sets requirements and test methods for sterile, single‑use catheter systems intended for neuraxial applications (spinal, epidural, peripheral nerve block and wound infusion catheter systems).

Q: What does it cover?

A: It covers intended performance, design, materials, manufacturing, sterilization, packaging, labelling and the tests needed to demonstrate conformity for neuraxial catheter systems; it also lists devices and uses in scope and specific exclusions.

Q: Who typically uses it?

A: Medical device manufacturers (design, regulatory and QA), clinical engineers, hospital procurement, regulatory reviewers and conformity assessment bodies; clinicians rely on compliant products that reference the standard.

Q: Is it current or superseded?

A: The 2018 edition (Edition 1) is published and was reviewed/confirmed by ISO (the version remains current following the ISO review cycle). Users should check with their national standards body or ISO for any amendments or subsequent revisions.

Q: Is it part of a series?

A: It is a standalone International Standard for neuraxial catheter systems but is commonly used alongside related catheter and connector standards (for example ISO 20697 for drainage catheters and the ISO 80369 series for small‑bore connectors) and general medical device standards (biocompatibility, sterility, risk management).

Q: What are the key keywords?

A: Neuraxial, epidural, spinal, peripheral nerve block, wound infusion, sterile, single‑use, catheter system, medical device, ISO 20698.