SIST 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)
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 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 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 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 16571:2024)
Celovita revizija trenutno objavljene različice iz leta 2014. Razširjeno področje uporabe vključuje sisteme za odsesavanje hlapov za endoskopijo (npr. minimalno invazivni posegi, laparoskopija).
Področje uporabe je zdaj naslednje:
Ta standard določa zahteve in smernice v zvezi z zasnovo, izdelavo, nameščanjem, delovanjem, zmogljivostjo, vzdrževanjem, servisiranjem, dokumentiranjem, preskušanjem in začetkom uporabe opreme za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih pripomočkov. Uporablja se za:
a) premične in mobilne sisteme za odsesavanje hlapov;
b) lokalne nepremične sisteme za odsesavanje hlapov;
c) namenske centralne cevovodne sisteme za sisteme za odsesavanje hlapov; ter
d) sisteme za odsesavanje hlapov v sklopu druge opreme (npr. laserska oprema).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Sistemi za odsesavanje hlapov, ki nastanejo zaradi uporabe medicinskih
pripomočkov (ISO 16571:2024)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
Rauchgasabsaugsysteme für Medizinprodukte (ISO 16571:2024)
Systèmes d'évacuation des fumées chirurgicales générées par l'utilisation de dispositifs
médicaux (ISO 16571:2024)
Ta slovenski standard je istoveten z: EN ISO 16571:2024
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.
EN ISO 16571
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Systems for evacuation of plume generated by medical
devices (ISO 16571:2024)
Systèmes d'évacuation des fumées chirurgicales Rauchgasabsaugsysteme für Medizinprodukte (ISO
générées par l'utilisation de dispositifs médicaux (ISO 16571:2024)
16571:2024)
This European Standard was approved by CEN on 1 March 2024.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16571:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 16571:2024) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2024, and conflicting national standards shall
be withdrawn at the latest by October 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 16571:2024 has been approved by CEN as EN ISO 16571:2024 without any modification.
International
Standard
ISO 16571
Second edition
Systems for evacuation of plume
2024-03
generated by medical devices
Systèmes d'évacuation des fumées chirurgicales générées par
l'utilisation de dispositifs médicaux
Reference number
ISO 16571:2024(en) © ISO 2024
ISO 16571:2024(en)
© ISO 2024
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
ISO 16571:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 7
4.1 Components .7
4.2 Systems .7
4.3 Capture device .8
4.4 Transfer tubing .9
4.5 Filtration subsystem .9
4.6 Control subsystem .9
4.7 Flow-generator .9
4.8 Exhaust subsystem .10
4.9 Colour coding .10
5 Portable and mobile system requirements . 10
5.1 General requirements .10
5.2 Acoustic noise test .10
5.3 Ingress protection . 12
6 Stationary and pipeline system requirements .12
6.1 Stationary plume evacuation systems . 12
6.2 Design . 12
6.3 Flow-generators . 13
6.4 Exhausts . 13
6.5 Flow-generator controls . 13
6.6 Pipeline .14
6.7 Terminal units .14
6.8 Commissioning and testing .14
7 Endoscopic and laparoscopic system requirements .15
7.1 Active PESs . 15
7.2 Passive PESs . 15
Annex A (informative) Rationale . 17
Annex B (informative) Plume evacuation system implementation .20
Annex C (normative) Plume removal efficiency test method .23
Annex D (normative) Colour coding .29
Annex E (normative) Information to be supplied to the healthcare facility .32
Annex F (informative) Acoustic testing muffler design .35
Bibliography .37
iii
ISO 16571:2024(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 need
...
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