EN ISO 16571:2024/prA1

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)

Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih pripomočkov - Dopolnilo A1 (ISO 16571:2024/DAM 1:2025)

General Information

• Status: Not Published
• Publication Date: 20-Dec-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: 4060 - Closure of enquiry - Enquiry
• Start Date: 18-Aug-2025
• Completion Date: 18-Aug-2025
• Ref Project: SIST EN ISO 16571:2024/oprA1:2025 - Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/DAM 1:2025)

Relations

• 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/prA1 is Amendment 1 to ISO 16571:2024, published by CEN/ISO. It addresses systems for evacuation of plume generated by medical devices (surgical smoke / plume) and updates definitions, performance limits and test requirements for plume evacuation subsystems (PES). The amendment is circulated as a draft for review and clarifies filtration, airflow generation, capture devices and testing expectations for manufacturers, healthcare providers and regulators.

Key Topics and Requirements

• Definitions and system types
  • Clarifies active PES (systems whose evacuation is accomplished through endoscopic or laparoscopic ports by an external vacuum source).
  • Defines capture device as the accessory that captures plume near the generation site and transfers it into tubing (single‑use or reusable).
• Filtration subsystem
  • Requires a particulate filtration assembly using ULPA performance referenced to ISO 29463-1:2024 (Table 1) and allows additional pre‑filters and adsorbers.
• Airflow generation and venturi use
  • Limits use of venturi-driven airflow: venturis shall not be driven with any medical gas if used to generate PES airflow greater than 20 L/min (see rationale in A.17).
• Testing and performance
  • Mandates noise testing for the combined flow‑generator and filtration subsystem.
  • When a PES is integrated into other equipment, testing in Clause 5.2 applies only to the PES component.
• Integration and source requirements
  • Active PES may be self‑powered or use mobile/portable/stationary/pipeline vacuum sources; those sources must comply with specified clauses.
• Informative rationale
  • Annex notes summarize research on particle concentration from electrosurgery tools and safety considerations around venturi use and pipeline depressurization.

Applications and Users

• Who uses this standard:
  • Medical device and evacuation-system manufacturers designing surgical smoke evacuators, capture devices, filtration modules and vacuum sources.
  • Biomedical engineers and procurement specialists specifying equipment performance and acceptance testing for hospitals and outpatient surgery centers.
  • Infection control, occupational health and safety teams implementing controls for surgical smoke exposure.
  • Regulatory and conformity assessment bodies referencing performance and testing requirements during certification and audits.
• Typical applications:
  • Design and testing of operating-room smoke evacuation units, integrated plume evacuation components in surgical systems, and portable suction-based capture systems for endoscopic and laparoscopic procedures.

Related Standards

• ISO 29463-1:2024 (ULPA/filtration efficiency standard referenced)
• ISO 4135 (definition of medical gas, referenced for venturi requirements)
• ISO/TC 121/SC 6 is the responsible technical committee for medical suction and evacuation systems.

Keywords: evacuation of plume, surgical smoke, plume evacuation system, ULPA filter, capture device, venturi, filtration subsystem, medical devices, ISO 16571 amendment.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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)
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
...