ISO 20697-2018 PDF

Full title and description

ISO 20697:2018 — Sterile drainage catheters and accessory devices for single use. This International Standard specifies requirements for sterile, single‑use drainage catheters, wound and fluid‑collection drainage systems, surgical drainage catheters and their components where the catheter is placed in a body cavity or wound (surgically or percutaneously) to drain fluid or air to the exterior.

Abstract

The standard defines general and specific performance, safety and test requirements (for example: risk management, biocompatibility, detectability, surface finish, size designation, connectors, MRI compatibility, sterilization) and details tests for kink stability, corrosion resistance, resistance to deformation, tensile strength of connections, flow rate, retention strength and balloon safety for drainage catheters and associated devices intended for single use. It also lists several exclusions (e.g. suction catheters, tracheal catheters, urethral catheters and certain stents or enteral/neuraxial devices).

General information

• Status: Published (International Standard). Confirmed as current in the ISO review cycle (reviewed/confirmed in 2023).
• Publication date: First edition published June 2018 (corrected versions issued August 2018).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 84 (medical devices).
• ICS / categories: 11.040.25 (syringes, needles and catheters).
• Edition / version: Edition 1 (2018-06); corrected English/French versions issued August 2018.
• Number of pages: 37 (ISO English edition page count as published).

Scope

ISO 20697:2018 applies to sterile, single‑use drainage catheters and related accessory devices designed to evacuate fluid or air from a body cavity or wound to the exterior either by natural drainage or connected to suction. It is intended to set minimum safety and performance requirements and test methods for these devices. The standard explicitly excludes suction catheters, tracheal catheters, urethral catheters (see ISO 20696), certain stents and other specialized devices (see related standards), neuraxial and enteral drainage catheters and coatings.

Key topics and requirements

• Intended performance and risk‑management requirements (manufacturer responsibility to demonstrate safety and performance).
• Biocompatibility and materials selection (references to ISO 10993 series where applicable).
• Marking, size designation and connector requirements (clear labelling and dimensional designations).
• Sterilization and packaging requirements to preserve sterility for single use.
• Mechanical and physical tests: kink stability, resistance to deformation, corrosion resistance, tensile/peak force tests for connections, retention strength and impact resistance.
• Functional performance tests: flow rate measurements, balloon inflation and integrity tests (where applicable), catheter inflation lumen integrity and volume maintenance.
• MRI compatibility and detectability requirements for devices intended to be used in or monitored by imaging.

Typical use and users

Manufacturers and designers of drainage catheters and single‑use accessory devices use ISO 20697:2018 to develop products that meet recognized safety and performance benchmarks. Regulatory affairs professionals, testing laboratories, quality managers, procurement teams in hospitals and healthcare providers, and conformity assessment bodies use the standard as a reference for product specifications, testing, acceptance and regulatory submissions. Clinical engineers and hospital supply committees consult the standard when evaluating device suitability for specific clinical applications.

Related standards

Standards and documents commonly referenced alongside ISO 20697 include ISO 20696 (sterile urethral catheters for single use), ISO 20695, ISO 20698 (other device families in the same series), ISO 10993 series (biocompatibility), ISO 11607 (packaging for terminally sterilized medical devices), ASTM F1828 (stents and related guidance), and regional adoptions such as EN ISO 20697:2018 (European adoption). Published references and cross‑references are listed in the ISO standard.

Keywords

drainage catheter; single‑use; sterile; medical device; catheter testing; kink stability; biocompatibility; flow rate; balloon safety; ISO 20697.

FAQ

Q: What is this standard?

A: ISO 20697:2018 is an International Standard that specifies requirements and test methods for sterile, single‑use drainage catheters and associated accessory devices intended to drain fluid or air from a body cavity or wound to the exterior.

Q: What does it cover?

A: It covers general and specific safety and performance requirements (materials, labelling, dimensional designation, sterility, MRI compatibility), and defines test methods for mechanical strength, kink resistance, flow rate, balloon integrity and other performance characteristics; it also lists explicit exclusions (e.g., suction catheters, tracheal catheters, urethral catheters).

Q: Who typically uses it?

A: Device manufacturers, regulatory and quality teams, test laboratories, hospital procurement and clinical engineering staff, and conformity assessment bodies use the standard to design, test, specify and assess single‑use drainage catheters.

Q: Is it current or superseded?

A: The first edition was published in June 2018 (with corrections in August 2018). ISO records indicate the document was reviewed/confirmed and remains current within the ISO review cycle (confirmed in 2023). Users should check with their national standards body or ISO for any later revisions or amendments.

Q: Is it part of a series?

A: Yes — ISO 20697 is one of several ISO documents addressing catheters and related single‑use medical devices; related documents include ISO 20696, ISO 20695 and ISO 20698, plus other cross‑referenced standards (for example, ISO 10993 series for biocompatibility).

Q: What are the key keywords?

A: Drainage catheter, single‑use, sterile, catheter testing, kink resistance, balloon safety, biocompatibility, flow rate, ISO 20697.