EN ISO 16571:2024
(Main)Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
This document applies to all types of plume evacuation systems (PESs), including
a) portable;
b) mobile;
c) stationary, including dedicated central pipelines;
d) PESs integrated into other equipment;
e) PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a) surgical facilities;
b) medical offices;
c) cosmetic treatment facilities;
d) medical teaching facilities;
e) dental clinics;
f) veterinary facilities.
This document provides guidance on the following aspects of PESs:
a) importance;
b) purchasing;
c) design;
d) manufacture;
e) documentation;
f) function;
g) performance;
h) installation;
i) commissioning;
j) testing;
k) training;
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
This document does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination; and
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.
Rauchgasabsaugsysteme für Medizinprodukte (ISO 16571:2024)
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 ist anzuwenden 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 ist nicht anzuwenden für:
a) Anästhesiegas-Fortleitungssysteme (AGSS), die in ISO 7396 2 behandelt werden;
b) medizinische Vakuumsysteme, die in ISO 7396 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 16571:2024)
Le présent document spécifie les exigences et les lignes directrices applicables aux systèmes et équipements utilisés pour évacuer les fumées chirurgicales générées par l’utilisation de dispositifs médicaux.
Le présent document s’applique à tous les types de systèmes d’évacuation des fumées chirurgicales (SEFC), notamment:
a) portables;
b) mobiles;
c) fixes, y compris canalisations centrales dédiées;
d) SEFC intégrés dans d’autres équipements;
e) SEFC pour procédures endoscopiques (par exemple, minimalement invasives, laparoscopiques).
Le présent document s’applique à tous les établissements de soins dans lesquels des SEFC sont utilisés, y compris, entre autres:
a) établissements chirurgicaux;
b) cabinets médicaux;
c) établissements de soins cosmétiques;
d) établissements d’enseignement médical;
e) cliniques dentaires;
f) cliniques vétérinaires.
Le présent document fournit des recommandations sur les aspects suivants des SEFC:
a) importance;
b) achat;
c) conception;
d) fabrication;
e) documentation;
f) fonction;
g) performance;
h) installation;
i) mise en service;
j) essais;
k) formation;
l) utilisation;
m) évaluation des risques;
n) entretien;
o) maintenance.
Le présent document ne s’applique pas aux systèmes suivants:
a) systèmes d’évacuation des gaz anesthésiques (SEGA) abordés dans l’ISO 7396-2;
b) systèmes de vide médical abordés dans l’ISO 7396-1;
c) systèmes de chauffage, ventilation et climatisation (CVC);
d) aspects liés à la sécurité des lasers, autres que la contamination atmosphérique; et
e) aspects liés à l’électrochirurgie, l’électrocautérisation et les outils chirurgicaux mécaniques, autres que la contamination atmosphérique produite par ces équipements découlant de l’interaction avec les tissus ou les matériaux.
Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih pripomočkov (ISO/FDIS 16571:2023)
General Information
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
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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
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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,
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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
...
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