ISO 16571:2024/Amd 1
(Amendment)Systems for evacuation of plume generated by medical devices — Amendment 1
Systems for evacuation of plume generated by medical devices — Amendment 1
Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs médicaux — Amendement 1
General Information
- Status
- Not Published
- 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
- 6000 - International Standard under publication
- Start Date
- 04-Apr-2026
- Completion Date
- 18-Apr-2026
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 22-Mar-2025
- Effective Date
- 15-Mar-2025
Overview
ISO 16571:2024/Amd 1 – Systems for evacuation of plume generated by medical devices – Amendment 1 – is an update published by the International Organization for Standardization (ISO). This standard, developed by ISO Technical Committee 121/Subcommittee 6 (ISO/TC 121/SC 6) with Secretariat support from ANSI, specifies important amendments to technical and safety requirements for systems that remove surgical plume produced by medical equipment. Surgical plume evacuation is critical in healthcare facilities for maintaining air quality and minimizing risks to both staff and patients during medical procedures, especially where electrosurgical or energy-based devices are used.
Key Topics
The amendment introduces several clarifications and technical improvements, focusing on:
- Terminology Updates: Modifies or strengthens definitions related to plume evacuation systems and capture devices for enhanced clarity.
- Venturi Usage Restrictions: Prohibits the use of medical gases for generating airflow via venturis above 20 l/min, aiming to prevent potential pipeline depressurization.
- Filtration System Requirements: Establishes the use of ultra-low penetration air (ULPA) filters with ISO 55 U efficiency (as per ISO 29463-1:2024) as a minimum standard.
- Noise Testing Protocols: Mandates dedicated testing of noise levels produced by the flow-generator and its filtration subsystem.
- Subsystem Integration Clauses: Clarifies that when evacuation systems are integrated into other medical equipment, testing and compliance apply specifically to the plume evacuation component.
- Vacuum Source Compliance: Specifies acceptable sources for vacuum generation (mobile, portable, stationary, or pipeline) and ensures compliance with key safety and performance clauses.
- Particle Concentration Guidance: Updates recommendations on particle concentration limits associated with specific electrosurgery tools to refine safety targets.
Applications
Plume evacuation systems are vital in modern clinical environments, with applications including:
- Operating Rooms and Surgical Suites: Ensuring proper removal of hazardous aerosols and particulates generated by medical devices, particularly during procedures utilizing monopolar and bipolar electrosurgery tools.
- Outpatient Clinics and Ambulatory Surgical Centers: Supporting smaller practice settings with effective plume control.
- Medical Device Manufacturing & Integration: Guiding manufacturers on the proper implementation and integration of plume evacuation modules into broader equipment systems.
- Healthcare Facility Compliance: Assisting hospitals and clinics in meeting international safety and air quality standards.
Adhering to the latest amendment ensures protection of healthcare workers from exposure to potentially toxic airborne contaminants and helps organizations maintain regulatory compliance.
Related Standards
The amendments refer to and align with several related international standards relevant to medical gas usage and air filtration, including:
- ISO 29463-1:2024: Specifies the test methods and efficiency classifications for ULPA filters.
- ISO 4135: Defines relevant medical gases in healthcare settings.
- ISO 16571:2024: The main standard on which this amendment is based, providing foundational requirements for plume evacuation systems.
Other related documents and standards may include regional guidelines for surgical smoke evacuation, workplace safety regulations, and additional ISO or IEC standards pertaining to medical device safety and performance.
For comprehensive implementation and ongoing compliance, organizations should consult ISO 16571:2024 and the full text of this latest amendment.
Buy Documents
ISO 16571:2024/FDAmd 1 - Systems for evacuation of plume generated by medical devices — Amendment 1 Released:23. 01. 2026
REDLINE ISO 16571:2024/FDAmd 1 - Systems for evacuation of plume generated by medical devices — Amendment 1 Released:23. 01. 2026
ISO 16571:2024/FDAmd 1 - Systemes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs médicaux — Amendement 1 Released:30. 01. 2026
Get Certified
Connect with accredited certification bodies for this standard

BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.

TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
ISO 16571:2024/Amd 1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Systems for evacuation of plume generated by medical devices — Amendment 1". This standard covers: Systems for evacuation of plume generated by medical devices — Amendment 1
Systems for evacuation of plume generated by medical devices — Amendment 1
ISO 16571:2024/Amd 1 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 16571:2024/Amd 1 has the following relationships with other standards: It is inter standard links to EN ISO 16571:2024/FprA1, ISO 16090-1:2022, ISO 16571:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 16571:2024/Amd 1 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)
FINAL DRAFT
Amendment
ISO 16571:2024/
FDAM 1
ISO/TC 121/SC 6
Systems for evacuation of plume
Secretariat: ANSI
generated by medical devices
Voting begins on:
2026-02-06
AMENDMENT 1
Voting terminates on:
Systèmes d'évacuation des fumées chirurgicales générées par
2026-04-03
l'utilisation de dispositifs médicaux
AMENDEMENT 1
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO 16571:2024/FDAM 1:2026(en) © ISO 2026
FINAL DRAFT
ISO 16571:2024/FDAM 1:2026(en)
Amendment
ISO 16571:2024/
FDAM 1
ISO/TC 121/SC 6
Systems for evacuation of plume
Secretariat: ANSI
generated by medical devices
Voting begins on:
AMENDMENT 1
Voting terminates on:
Systèmes d'évacuation des fumées chirurgicales générées par
l'utilisation de dispositifs médicaux
AMENDEMENT 1
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 16571:2024/FDAM 1:2026(en) © ISO 2026
ii
ISO 16571:2024/FDAM 1:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement t
...
ISO 16571:2024/FDAmd 1
ISO/TC 121/SC 6
Secretariat: ANSI
Date: 2026-01-23
Systems for evacuation of plume generated by medical devices
AMENDMENT 1
Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs médicaux
AMENDEMENT 1
FDIS stage
TTTThhhhiiiis drs drs drs draaaafffftttt i i i is s s s susususubbbbmmmmiiiitttttttteeeed d d d ttttoooo aaaa ppppaaaarrrraaaallellellellel l l l vvvvooootttteeee i i iinnnn IIIISSSSOOOO,,,, CCCCEEEEN.N.N.N.
ISO 16571:2024/FDAmd 1(en)
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: + 41 22 749 01 11
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/TC121/SC6 ISO/DIS 16571Amd1:2025
18/11/25 N222ISO 16571:2024/FDAmd 1(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directiveswww.iso.org/directives).).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patentswww.iso.org/patents. ISO shall not be held responsible for identifying any or all such
patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment,
...
PROJET FINAL
Amendement
ISO 16571:2024/
FDAM 1
ISO/TC 121/SC 6
Systèmes d'évacuation des fumées
Secrétariat: ANSI
chirurgicales générées par
Début de vote:
l'utilisation de dispositifs médicaux
2026-02-06
AMENDEMENT 1
Vote clos le:
2026-04-03
Systems for evacuation of plume generated by medical devices
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO 16571:2024/FDAM 1:2026(fr) © ISO 2026
PROJET FINAL
ISO 16571:2024/FDAM 1:2026(fr)
Amendement
ISO 16571:2024/
FDAM 1
ISO/TC 121/SC 6
Systèmes d'évacuation des fumées
Secrétariat: ANSI
chirurgicales générées par
Début de vote:
l'utilisation de dispositifs médicaux
2026-02-06
AMENDEMENT 1
Vote clos le:
2026-04-03
Systems for evacuation of plume generated by medical devices
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO 16571:2024/FDAM 1:2026(fr) © ISO 2026
ii
ISO 16571:2024/FDAM 1:2026(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir https://www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n’avait pas
reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il y a lieu d’avertir les responsables de la mise en application du présent document que des informations
plus récentes sont susceptibles de figurer dans la base de données
...












Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...