SIST EN ISO 16571:2024/A1:2026

Rauchgasabsaugsysteme für Medizinprodukte - Änderung 1 (ISO 16571:2024/Amd 1:2026)

Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs médicaux - Amendement 1 (ISO 16571:2024/Amd 1:2026)

Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih pripomočkov - Dopolnilo A1 (ISO 16571:2024/Amd 1:2026)

General Information

• Status: Published
• Public Enquiry End Date: 30-Jul-2025
• Publication Date: 25-May-2026
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 21-May-2026
• Due Date: 26-Jul-2026
• Completion Date: 26-May-2026
• Ref Project: EN ISO 16571:2024/A1:2026 - Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/Amd 1:2026)

Relations

• Amends: SIST EN ISO 16571:2024 - Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
• Effective Date: 01-Jul-2026

Overview

SIST EN ISO 16571:2024/A1:2026 is an important amendment to the international standard ISO 16571:2024, concerning systems for evacuation of plume generated by medical devices. Medical plumes, such as surgical smoke produced during procedures using electrosurgical or laser devices, can pose significant health risks to patients and healthcare personnel. This amendment provides updated requirements and enhanced guidance for system components, terminology, safety, and testing, ensuring better safety, performance, and environmental control in medical settings.

This amendment is published by SIST, the Slovenian Institute for Standardization, in alignment with the ISO Technical Committee 121/Subcommittee 6 (ISO/TC 121/SC 6), focusing on anaesthetic, respiratory, and reanimation equipment.

Key Topics

• Terminology Updates:
  The amendment clarifies and updates critical definitions:

  • Active Plume Evacuation Systems (PES): Systems designed for plume evacuation via endoscopic/laparoscopic ports using an external vacuum source.
  • Capture Devices: Accessories placed to capture plume at the point of generation, available in single-use or reusable forms.

• System Design and Performance:

  • Requirements on the use of venturi devices prohibit their operation with medical gases when generating airflows exceeding 20 liters/min, mitigating risk to pipeline systems.
  • Details regarding the necessary particulate filtration capability, mandating at least ULPA filter ISO 55 U efficiency, as outlined in ISO 29463-1:2024.

• Testing and Compliance:

  • Procedures for noise measurement, accounting for the flow generator and filtration subsystem.
  • Guidelines for testing PES components when integrated within larger systems; only the PES is subject to direct evaluation.

• Operational Guidance:

  • Active PESs may be powered by various vacuum sources, including stationary, portable, or pipeline sources, and must comply with specific requirements regarding safety and noise control.

• Health and Safety Considerations:

  • Particle concentration limits in plume removal based on research findings, confirming that maximum concentrations support effective reduction strategies without setting unrealistic absolute thresholds.

Applications

Proper plume evacuation systems are essential for a wide range of medical procedures where devices generate smoke or aerosols. Key application areas include:

• Operating Rooms: Ensures that hazardous aerosols and particles generated by electrosurgery, laser surgery, or cautery are effectively captured and filtered.
• Endoscopic and Laparoscopic Procedures: Specialized requirements for plume evacuation through minimally invasive surgery ports.
• Hybrid Operating Environments: Integrated systems in advanced surgical suites where safety, air quality, and compliance with infection control guidelines are critical.
• Equipment Manufacturing: Provides manufacturers with updated technical specifications for design, testing, and labeling of new or existing plume evacuation systems.

These updated requirements help hospitals, clinics, and device manufacturers ensure compliance, safeguard occupational health, and enhance the quality and effectiveness of plume management in clinical practice.

Related Standards

For further guidance and complementary requirements, refer to:

• ISO 16571:2024 - Original standard for systems for evacuation of plume generated by medical devices
• ISO 29463-1:2024 - High-efficiency filtration (ULPA filter requirements)
• ISO 4135 - Definition and requirements for medical gases
• EN ISO 16571:2024 - European adoption of the standard
• ICS 11.040.10 - Classification under anaesthetic, respiratory, and reanimation equipment

These standards collectively support a robust framework for the specification, testing, and maintenance of medical plume evacuation systems, addressing both safety and operational performance.

By applying SIST EN ISO 16571:2024/A1:2026, stakeholders contribute to safer surgical environments, improved healthcare outcomes, and regulatory compliance in the use of medical devices that generate plumes.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2026
Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih
pripomočkov - Dopolnilo A1 (ISO 16571:2024/Amd 1:2026)
Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO
16571:2024/Amd 1:2026)
Rauchgasabsaugsysteme für Medizinprodukte - Änderung 1 (ISO 16571:2024/Amd
1:2026)
Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs
médicaux - Amendement 1 (ISO 16571:2024/Amd 1:2026)
Ta slovenski standard je istoveten z: EN ISO 16571:2024/A1:2026
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16571:2024/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2026
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Systems for evacuation of plume generated by medical
devices - Amendment 1 (ISO 16571:2024/Amd 1:2026)
Systèmes d'évacuation des fumées chirurgicales Rauchgasabsaugsysteme für Medizinprodukte -
générées par l'utilisation de dispositifs médicaux - Änderung 1 (ISO 16571:2024/Amd 1:2026)
Amendement 1 (ISO 16571:2024/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 16571:2024; it was approved by CEN on 4 May 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16571:2024/A1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16571:2024/A1:2026) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 16571:2024 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by November 2026,
and conflicting national standards shall be withdrawn at the latest by November 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 16571:2024/Amd 1:2026 has been approved by CEN as EN ISO 16571:2024/A1:2026
without any modification.
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 me
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