Overview

ISO 20697:2018 - Sterile drainage catheters and accessory devices for single use defines safety, performance and validation requirements for sterile, single‑use drainage catheters and associated components used to drain fluid or air from body cavities or wounds. It covers surgical and percutaneous placement, gravity or suction drainage, retention features (e.g., balloons, pigtails) and the assembly of drainage systems. The standard also specifies manufacturer information, labelling and instructions for use.

Note: ISO 20697 does not apply to suction catheters, tracheal or urethral catheters, stents, neuraxial or enteral catheters, gastrostomy‑placed digestive tract drains, or coatings - related documents are referenced for those devices.

Key topics and technical requirements

ISO 20697 sets out general and specific requirements including:

Intended performance - ability to access target site, maintain drainage, and prevent undesired dislodgement when retention means are used.
Risk management & biocompatibility - requires a documented risk analysis and biological evaluation (references include ISO 14971 and ISO 10993‑1).
Design and labelling - size designation (outer diameter, effective length), connectors, detectability and surface finish.
Sterilization & MRI compatibility - sterilization validation and information on MRI safety where applicable.
Mechanical and functional tests - kink stability, corrosion resistance, deformation under suction, peak tensile force of connections, impact resistance, flow rate, retention strength, balloon safety, inflation‑lumen integrity and leakage resistance.
Manufacturer information - marking, packaging, and instructions for safe use and release of retention features.

The standard includes multiple normative and informative annexes (A–M) that define test methods for the above performance attributes.

Practical applications and users

ISO 20697 is intended for:

Medical device manufacturers designing and validating sterile single‑use drainage catheters, collection bags, connectors and accessory devices.
Quality assurance and regulatory teams preparing technical files and conformity evidence.
Test laboratories executing standardized mechanical and functional tests defined in the annexes.
Hospital procurement, clinical engineers and clinicians who need to compare devices by standardized claims (e.g., flow rate, retention strength, MRI compatibility).

Using ISO 20697 helps ensure consistent product safety, regulatory compliance, and clear labelling for clinical use.

Related standards (if applicable)

ISO 10993‑1 (biocompatibility)
ISO 14155 (clinical investigations)
ISO 80369‑1 (small‑bore connectors)
ISO 20696, ISO 20698, ISO 20695 (related catheter types)
ISO 14630 and ASTM F1828‑97 (stent guidance)

Keywords: ISO 20697, sterile drainage catheters, single‑use drainage systems, medical device standards, catheter testing, biocompatibility, sterilization, risk management.

Overview

Key topics and technical requirements

ISO 20697 sets out general and specific requirements including:

Intended performance - ability to access target site, maintain drainage, and prevent undesired dislodgement when retention means are used.
Risk management & biocompatibility - requires a documented risk analysis and biological evaluation (references include ISO 14971 and ISO 10993‑1).
Design and labelling - size designation (outer diameter, effective length), connectors, detectability and surface finish.
Sterilization & MRI compatibility - sterilization validation and information on MRI safety where applicable.
Mechanical and functional tests - kink stability, corrosion resistance, deformation under suction, peak tensile force of connections, impact resistance, flow rate, retention strength, balloon safety, inflation‑lumen integrity and leakage resistance.
Manufacturer information - marking, packaging, and instructions for safe use and release of retention features.

The standard includes multiple normative and informative annexes (A–M) that define test methods for the above performance attributes.

Practical applications and users

ISO 20697 is intended for:

Medical device manufacturers designing and validating sterile single‑use drainage catheters, collection bags, connectors and accessory devices.
Quality assurance and regulatory teams preparing technical files and conformity evidence.
Test laboratories executing standardized mechanical and functional tests defined in the annexes.
Hospital procurement, clinical engineers and clinicians who need to compare devices by standardized claims (e.g., flow rate, retention strength, MRI compatibility).

Using ISO 20697 helps ensure consistent product safety, regulatory compliance, and clear labelling for clinical use.

Related standards (if applicable)

ISO 10993‑1 (biocompatibility)
ISO 14155 (clinical investigations)
ISO 80369‑1 (small‑bore connectors)
ISO 20696, ISO 20698, ISO 20695 (related catheter types)
ISO 14630 and ASTM F1828‑97 (stent guidance)

Keywords: ISO 20697, sterile drainage catheters, single‑use drainage systems, medical device standards, catheter testing, biocompatibility, sterilization, risk management.

ISO 20697:2018 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards (if applicable)

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards (if applicable)

Похожие стандарты

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