ISO 16571-2024 Systems for evacuation of plumegenerated by medical devices

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Systems for evacuation of plume

generated by medical devices

Systèmes d'évacuation des fumées chirurgicales générées par

I'utilisation de dispositifs médicaux

Reference number

ISO 16571:2024(en)

International

Standard

ISO 16571

Second edition

2024-03

◎ISO 2024

ISO16571:2024(en)

@ISO 2024

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

or ISO's member body in the country of the requester.

ISO copyright office

CP401·Ch.de Blandonnet 8

CH-1214 Vernier,Geneva

Phone:+41227490111

Email:copyright@iso.org

Website: www.iso.org

Published in Switzerland

iii

ISO16571:2024(en)

Contents Page

Foreword......................................................................................................................................................................iv

Introduction............................................................................................................................................................... V

1 Scope ............................................................................................................................................................... 1

2 Normative references ...................................................................................................................................

3 Terms and definitions ..................................................................................................................................

4 General requirements ...................................................................................................................................

4.1 Components............................................................................................................................................

4.2 Systems ...............................................................................................................................................

4.3 Capture device......................................................................................................................................

4.4 Transfer tubing ...................................................................................................................................

4.5 Filtration subsystem ...........................................................................................................................

4.6 Control subsystem...............................................................................................................................

4.7 Flow-generator.......................................................................................................................................

4.8 Exhaust subsystem............................................................................................................................10

4.9 Colour coding...................................................................................................................................... 10

5Portable 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

AnnexA(informative) Rationale........................................................................................................................... 17

Annex B(informative) Plume evacuation system implementation................................................................20

Annex C(normative) Plume removal efficiency test method ....................................................................... 23

Annex D(normative) Colour codin...................................................................................................................... 29

Annex E(normative) Information to be supplied to the healthcare facility............................................... 32

Annex F (informative) Acoustic testing muffler design ................................................................................... 35

Bibliography ................................................ ……………………………………………………………………………… 37

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标签： #ISO #16571

摘要：

SystemsforevacuationofplumegeneratedbymedicaldevicesSystèmesd'évacuationdesfuméeschirurgicalesgénéréesparI'utilisationdedispositifsmédicauxReferencenumberISO16571:2024(en)InternationalStandardISO16571Secondedition2024-03◎ISO2024iiISO16571:2024(en)COPYRIGHTPROTECTEDDOCUMENT@ISO2024Allrightsreserved.U...

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ISO 16571-2024 Systems for evacuation of plumegenerated by medical devices

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