ISO 16571:2024/Amd 1:2026

Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs médicaux — Amendement 1

General Information

• Status: Published
• Publication Date: 04-May-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: ISO/TC 121/SC 6 - Medical gas supply systems
• Drafting Committee: ISO/TC 121/SC 6/WG 7 - Plume evacuation systems
• Current Stage: 6060 - International Standard published
• Start Date: 05-May-2026
• Due Date: 13-Sep-2026
• Completion Date: 05-May-2026

Relations

• Consolidates: EN ISO 16571:2024/FprA1 - Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/FDAmd1:2026)
• Effective Date: 12-Feb-2026
• Consolidates: ISO 16090-1:2022 - Machine tools safety — Machining centres, milling machines, transfer machines — Part 1: Safety requirements
• Effective Date: 22-Mar-2025
• Amends: ISO 16571:2024 - Systems for evacuation of plume generated by medical devices
• Effective Date: 15-Mar-2025

Overview

ISO 16571:2024/Amd 1:2026 – Systems for Evacuation of Plume Generated by Medical Devices is an important amendment to the international standard that addresses the enhancement of safety features, definitions, and performance criteria for plume evacuation systems (PES) used in healthcare environments. This amendment, developed by the ISO Technical Committee 121, Subcommittee 6 (ISO/TC 121/SC 6), in collaboration with relevant European standardization bodies, strengthens requirements to ensure the effectiveness of systems designed to control and remove surgical plume generated by medical devices.

Surgical plume, consisting of gaseous by-products produced during medical procedures (such as laser surgery or electrosurgery), poses risks to patient safety and occupational health. This amendment updates system definitions, technical requirements, and test methods, ensuring that medical device manufacturers, healthcare providers, and facility managers can implement improved plume management solutions.

Key Topics

• Updated Definitions: Adjustments to terminology and the scope of components such as capture devices and filtration systems, improving clarity for manufacturers and users.
• Filtration Requirements: Enhanced criteria for particulate filter assemblies, mandating the use of ultra-low penetration air (ULPA) filters meeting ISO 29463-1:2024 standards, ensuring optimal plume filtration performance.
• Venturi Usage: Specification that venturis in PES must not be driven by medical gases if gas flow exceeds 20 l/min, mitigating risks to medical gas supply infrastructure.
• Noise Testing: Clear guidelines for evaluating noise generated by the flow-generator and filtration subsystems to address occupational safety and comfort.
• Integrated Component Testing: Clarification that performance testing requirements apply specifically to the PES component when integrated into multi-function medical devices.
• Source Requirements: Stipulation that the vacuum source for active PES must meet defined system requirements, whether it is stationary, mobile, or pipeline-based.
• Plume Particle Concentration: Research-backed limits on particle concentration in monopolar and bipolar electrosurgery plume, aiding risk assessment for exposure.

Applications

• Healthcare Facilities: Assists hospitals, surgical centers, and clinics in selecting and maintaining compliant plume evacuation systems, ensuring a safer environment for patients and staff.
• Medical Device Manufacturers: Provides clear requirements for the design, testing, and integration of plume evacuation subsystems in new medical equipment.
• Occupational Safety: Enhances efforts to control airborne contaminants in operating rooms, reducing health risks associated with surgical smoke for clinical staff.
• Regulatory Compliance: Facilitates adherence to national and international safety regulations, supporting procurement and installation of certified plume evacuation solutions.

Related Standards

• ISO 16571:2024 - Original standard for systems for evacuation of plume generated by medical devices.
• ISO 29463-1:2024 - High-efficiency air filtration standard referenced for ULPA filter requirements.
• ISO 4135 - Defines medical gas terminologies cited in the amendment.
• IEC Standards - For related electrotechnical requirements in medical equipment.
• CEN/TC 215 - European standards closely aligned with ISO requirements for respiratory and anaesthetic equipment.

Implementing ISO 16571:2024/Amd 1:2026 supports advanced risk management practices, promotes patient and staff safety, and aligns medical facilities with the latest international best practices for surgical plume management.

Standards Content (Sample)

International
Standard
ISO 16571
Second edition
Systems for evacuation of plume
2024-03
generated by medical devices
AMENDMENT 1
AMENDMENT 1
2026-05
Systèmes d'évacuation des fumées chirurgicales générées par
l'utilisation de dispositifs médicaux
AMENDEMENT 1
Reference number
ISO 16571:2024/Amd.1:2026(en) © ISO 2026

ISO 16571:2024/Amd.1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 16571:2024/Amd.1:2026(en)
Foreword
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This document was prepared by Tech
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Norme
internationale
ISO 16571
Deuxième édition
Systèmes d'évacuation des fumées
2024-03
chirurgicales générées par
l'utilisation de dispositifs médicaux
AMENDEMENT 1
2026-05
AMENDEMENT 1
Systems for evacuation of plume generated by medical devices
AMENDMENT 1
Numéro de référence
ISO 16571:2024/Amd.1:2026(fr) © ISO 2026

ISO 16571:2024/Amd.1:2026(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2026
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse
ii
ISO 16571:2024/Amd.1:2026(fr)
Avant-propos
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Le présent document a été élaboré par le comité technique ISO/TC 121, Matériel d’ane
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