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/FDAmd1:2026)

General Information

• Status: Published
• Publication Date: 12-May-2026
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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
• Ref Project: SIST EN ISO 16571:2024/kFprA1:2026 - Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/FDAmd1:2026)

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.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16571:2024/oprA1:2025
01-julij-2025
Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih
pripomočkov - Dopolnilo A1 (ISO 16571:2024/DAM 1:2025)
Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO
16571:2024/DAM 1:2025)
Rauchgasabsaugsysteme für Medizinprodukte - Änderung 1 (ISO 16571:2024/DAM
1:2025)
Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs
médicaux - Amendement 1 (ISO 16571:2024/DAM 1:2025)
Ta slovenski standard je istoveten z: EN ISO 16571:2024/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 16571:2024/oprA1:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 16571:2024/oprA1:2025

SIST EN ISO 16571:2024/oprA1:2025
DRAFT
Amendment
ISO 16571:2024/
DAM 1
ISO/TC 121/SC 6
Systems for evacuation of plume
Secretariat: ANSI
generated by medical devices
Voting begins on:
AMENDMENT 1
2025-05-26
Systèmes d'évacuation des fumées chirurgicales générées par Voting terminates on:
l'utilisation de dispositifs médicaux 2025-08-18
AMENDEMENT 1
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO 16571:2024/DAM 1:2025(en)
SIST EN ISO 16571:2024/oprA1:2025
DRAFT
ISO 16571:2024/DAM 1:2025(en)
Amendment
ISO 16571:2024/
DAM 1
ISO/TC 121/SC 6
Systems for evacuation of plume
Secretariat: ANSI
generated by medical devices
Voting begins on:
AMENDMENT 1
Systèmes d'évacuation des fumées chirurgicales générées par Voting terminates on:
l'utilisation de dispositifs médicaux
AMENDEMENT 1
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be rep
...