prEN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023)

Full revision of currently published 2014 version.  Additionally, expand scope to include plume evacuation systems for endoscopic procedures (e.g. minimally invasive, laparoscopic).
The scope is now the following:
This Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. It is applicable to:
a) portable and mobile plume evacuation systems,
b) local stationary plume evacuation systems,
c) dedicated central pipeline systems for plume evacuation systems, and
d) plume evacuation systems integrated into other equipment (e.g. laser equipment).

Rauchgasabsaugsysteme für Medizinprodukte (ISO/DIS 16571:2023)

1.1 Dieses Dokument legt Anforderungen und Richtlinien für Systeme und Geräte fest, die zur Absaugung von Rauch, der von Medizinprodukten erzeugt wird, verwendet werden.
1.2 Dieses Dokument gilt für alle Arten von Rauchgas-Absaugsystemen (PES), einschließlich
a) tragbaren;
b) fahrbaren;
c) stationären, einschließlich spezieller zentraler Rohrleitungen;
d) in andere Geräte integrierte PES;
e) PES für endoskopische Verfahren (z.B. minimal-invasiv, laparoskopisch).
1.3 Dieses Dokument gilt für alle Gesundheitseinrichtungen, in denen PES eingesetzt werden, einschließlich, aber nicht beschränkt auf
a) chirurgische Einrichtungen;
b) medizinische Praxen;
c) Einrichtungen für kosmetische Behandlungen;
d) medizinische Lehreinrichtungen;
e) zahnärztliche Kliniken;
f) tierärztliche Einrichtungen.
1.4 Dieses Dokument enthält Anleitungen zu den folgenden Aspekten von PES:
a) Wichtigkeit;
b) Beschaffung;
c) Planung;
d) Herstellung;
e) Dokumentation;
f) Funktion;
g) Leistung;
h) Installation;
i) Inbetriebnahme;
j) Prüfung;
k) Schulung;
l) Gebrauch;
m) Risikobewertung;
n) Instandhaltung;
o) Wartung.
1.5 Dieses Dokument gilt nicht für:
a) Anästhesiegas-Fortleitungssysteme (AGSS), die in ISO7396-2 behandelt werden;
b) medizinische Vakuumsysteme, die in ISO7396-1 behandelt werden;
c) Anlagen für Heizung, Lüftung und Klimatisierung (HVAC);
d) andere Aspekte der Lasersicherheit als luftgetragene Schmutzstoffe; und
e) Aspekte der Elektrochirurgie, Elektrokauterisation und der mechanischen chirurgischen Instrumente mit Ausnahme von luftgetragenen Schmutzstoffen, die von diesen Geräten durch die Interaktion mit Gewebe oder Materialien verursacht werden.

Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs médicaux (ISO/DIS 16571:2023)

Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih pripomočkov (ISO/DIS 16571:2023)

General Information

• Status: Not Published
• Publication Date: 02-Dec-2024
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 08-Sep-2023
• Due Date: 05-Mar-2024
• Completion Date: 08-Sep-2023
• Ref Project: oSIST prEN ISO 16571:2023 - Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023)

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 16571:2023
01-april-2023
Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih
pripomočkov (ISO/DIS 16571:2023)
Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023)
Rauchgasabsaugsysteme für Medizinprodukte (ISO/DIS 16571:2023)
Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs
médicaux (ISO/DIS 16571:2023)
Ta slovenski standard je istoveten z: prEN ISO 16571
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 16571:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 16571:2023

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oSIST prEN ISO 16571:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16571
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-01-31 2023-04-25
Systems for evacuation of plume generated by medical
devices
Systèmes de gaz médicaux — Systemes d'évacuation des effluents gazeux générés par l'utilisation de
dispositifs medicaux
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16571:2023(E)
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. © ISO 2023

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oSIST prEN ISO 16571:2023
ISO/DIS 16571:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16571
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:

Systems for evacuation of plume generated by medical
devices
Systèmes de gaz médicaux — Systemes d'évacuation des effluents gazeux générés par l'utilisation de
dispositifs medicaux
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 16571:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 16571:2023
ISO/DIS 16571:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Ter
...