EN ISO 16571:2024/A1:2026
(Amendment)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)
Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih pripomočkov - Dopolnilo A1 (ISO 16571:2024/Amd 1:2026)
General Information
- Status
- Published
- Publication Date
- 12-May-2026
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 3 - Medical gas supply systems
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 13-May-2026
- Completion Date
- 13-May-2026
Relations
- Consolidated By
ISO 16571:2024/Amd 1:2026 - Systems for evacuation of plume generated by medical devices — Amendment 1 - Effective Date
- 12-Feb-2026
- Amends
EN ISO 16571:2024 - Systems for evacuation of plume generated by medical devices (ISO 16571:2024) - Effective Date
- 17-Mar-2025
Overview
EN ISO 16571:2024/A1:2026 is an important amendment to the international standard for systems used in the evacuation of plume (smoke or vapor) generated by medical devices during surgical and clinical procedures. Issued by CEN and ISO, this standard specifies updated definitions, safety requirements, filtration criteria, and testing methods for plume evacuation systems (PES). These systems protect medical staff and patients from potentially hazardous surgical smoke, improving air quality in healthcare environments.
Key Topics
Active Plume Evacuation Systems (Active PES):
Updated definitions clarify that evacuation can occur via endoscopic or laparoscopic ports using external vacuum sources. Systems can be self-powered or use various vacuum sources (mobile, portable, stationary, pipeline).Capture Device:
The amendment defines capture devices as accessories designed to collect plume at its source and transfer it for filtration. These devices can be single-use or reusable.Filtration Performance:
The filtration subsystem must include a particulate filter assembly achieving at least ultra-low penetration air (ULPA) filter efficiency (ISO 29463-1:2024). Pre-filters or adsorbers may also be integrated to enhance filtration capability.Flow Generation & Noise Testing:
Flow-generating components and their filtration subsystems must undergo noise measurement tests to ensure compliance with comfort and safety levels in clinical settings.System Integration and Scope:
When a PES is integrated with other medical equipment, the updated standard specifies that relevant requirements and testing pertain directly to the PES component.Venturi Use Limitation:
For venturi-type airflow generators exceeding 20 liters/min, the amendment states these must not be powered by medical gases, reducing risks of pipeline depressurization.
Applications
Plume evacuation systems are critical for:
- Operating Rooms & Surgical Suites:
Removing plume during electrosurgery, laser surgery, or energy-based procedures that generate airborne contaminants. - Endoscopic & Laparoscopic Procedures:
The standard offers guidance for ensuring safe plume evacuation within minimally invasive environments. - Healthcare Facility Compliance:
Supporting hospitals and clinics in meeting occupational health and safety regulations by reducing staff and patient exposure to harmful surgical smoke. - Device Manufacturing and Quality Assurance:
Providing clear requirements for medical device manufacturers in the design, testing, and integration of PES components for new medical device systems or upgrades.
Related Standards
ISO 16571:2024:
Base standard for systems and requirements on plume evacuation generated by medical devices.EN ISO 29463-1:2024:
Defines ULPA filter efficiency requirements referenced in the amendment.ISO 4135:
Specifies terms and definitions for medical gases, relevant for venturi device requirements.ICS 11.040.10:
International Classification for Standards covering anesthetic, respiratory, and reanimation equipment.
EN ISO 16571:2024/A1:2026 ensures that medical device plume evacuation systems meet stringent safety, performance, and filtration standards. Adherence to these guidelines promotes staff safety, regulatory compliance, and safe integration of plume evacuation into diverse clinical workflows. For device designers, hospital system integrators, and healthcare quality managers, following this amendment is essential for modern surgical environments.
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Frequently Asked Questions
EN ISO 16571:2024/A1:2026 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/Amd 1:2026)". This standard covers: Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/Amd 1:2026)
Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/Amd 1:2026)
EN ISO 16571:2024/A1:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general; 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 16571:2024/A1:2026 has the following relationships with other standards: It is inter standard links to ISO 16571:2024/Amd 1:2026, EN ISO 16571:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 16571:2024/A1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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