EN ISO 16571:2024

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
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
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 needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 16571:2014), which has been technically
revised.
The main changes are as follows:
— the scope has been expanded to include endoscopic systems and there are therefore significant changes
throughout.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 16571:2024(en)
Introduction
Certain surgical, diagnostic, and therapeutic techniques can generate noxious airborne contaminants
(plume) as by-products, particularly from procedures that include the cutting, ablation, cauterization, or
mechanical manipulation of target tissue by energy-based devices such as lasers, electrosurgery generators,
broadband light sources, and ultrasonic instruments. Energy-based contact with articles such as tubing,
swabs, and skin preparation solutions can produce additional chemicals. This document was developed in
response to awareness of the potential hazards to patients and staff of plume generated by these techniques
in healthcare settings.
Plume can contain a variety of contaminants: airborne chemicals, particulates, ultrafine particles, aerosols,
gases, vapours, volatile organic compounds, tissue fragments, cellular material and blood-borne pathogens,
posing a hazard to exposed persons. Additionally, plume reduces the clinician’s ability to clearly see the
operative field, resulting in unsafe operating conditions.
This document specifies requirements for systems for evacuation of plume generated in healthcare facilities.
It is intended for those persons involved in the design, construction, inspection, and operation of healthcare
facilities. Those persons involved in the design, manufacture, installation, testing, and use of equipment and
components for plume evacuation systems should also be aware of the contents of this document.
This document provides the information needed to capture, filter, and remove surgical plume.
The objectives of this document are to ensure the following:
a) continuous extraction at specified pressures and flows;
b) use of suitable materials for all components of the system;
c) provision of monitoring indicators and alarm systems;
d) correct rating of filtration systems;
e) correct indication of filter life;
f) correct marking and labelling;
g) electrical and environmental testing;
h) correct installation;
i) testing, commissioning, and certification;
j) provision of guidance on operational management;
k) appropriate manufacturer’s instructions for use, training, service, and maintenance.

v
International Standard ISO 16571:2024(en)
Systems for evacuation of plume generated by medical devices
1 Scope
1.1 This document specifies requirements and guidelines for systems and equipment used to evacuate
plume generated by medical devices.
1.2 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).
1.3 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.
1.4 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;
ISO 16571:2024(en)
l) use;
m) risk assessment;
n) servicing;
o) maintenance.
1.5 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
1)
ISO 3744:— , Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 7396-2, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
ISO 7779:2018, Acoustics — Measurement of airborne noise emitted by information technology and
telecommunications equipment
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15900, Determination of particle size distribution — Differential electrical mobility analysis for aerosol
particles
ISO 20417, Medical devices — Information to be supplied by the manufacturer
2)
ISO 29463-1:— , High efficiency filters and filter media for removing particles from air — Part 1: Classification,
performance, testing and marking
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
1) Under preparation. Stage at the time of publication: ISO/FDIS 3744:2024.
2) Under preparation. Stage at the time of publication: ISO/FDIS 29463-1:2024.

ISO 16571:2024(en)
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
active PES
PES whose evacuation is accomplished through endoscopic or laparoscopic ports by external vacuum source
or a closed loop filtration system
3.2
adsorber
device that removes volatile organic compounds or specified gases from a gas stream by a process of
adsorption
EXAMPLE Activated carbon filter.
[SOURCE: ISO 4135:2022, 3.1.4.2]
3.3
anaesthetic gas scavenging system
AGSS
complete system which is connected to the exhaust port(s) of a breathing system or to other equipment for
the purpose of conveying expired and/or excess anaesthetic gases and vapours to an appropriate place of
discharge
[SOURCE: ISO 7396-2:2007, 3.11]
3.4
capture device
accessory that captures the plume near the site of generation and passes it into the transfer tubing. A capture
device can be single use or reusable
3.5
connector
fitting to join two or more components
[SOURCE: ISO 4135:2022, 3.1.4.5]
3.6
control terminal
PES pipeline end point which includes elements of the systems such as filters, flow controls, etc. integrated
into the terminal
3.7
design flow
specified as the flow which the PES is intended to deliver at the terminal units
3.8
design vacuum
specified as the vacuum which the PES is intended to deliver at the terminal units
3.9
designer
natural or legal person who lays out, sizes and specifies the constituent parts of the pipeline PES as they will
be installed
3.10
dilution ratio
amount of aerosol dilution applied to a sample flow to avoid particle meter saturation

ISO 16571:2024(en)
3.11
electrocautery
surgical technique to cauterize tissue by means of an instrument heated by an electric current for therapeutic
purposes
3.12
electrosurgery
surgical technique that uses a radiofrequency electric current passing through the patient to cut, ablate, or
coagulate tissue for therapeutic purposes
Note 1 to entry: Electrosurgery is also known as high frequency (HF) surgery or surgical diathermy.
3.13
filtration subsystem
part of the overall plume evacuation system which separates the plume from the air
3.14
flow-generator
part of a plume evacuation system that provides flow and vacuum for evacuating plume
3.15
installer
natural or legal person with responsibility for the on-site assembly of pipeline PES
3.16
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, and labelling of a device
before it is placed on the market under their own name, regardless of whether these operations are carried
out by that person or on their behalf by a third party
3.17
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material
or other similar or related article, intended by the manufacturer to be used, alone or in combination, for
human beings, for one or more of the specific medical purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,
— providing information by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its function by such means
Note 1 to entry: Products which can be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 14971:2019, 3.10]

ISO 16571:2024(en)
3.18
medical supply unit
permanently installed medical electrical equipment intended to supply electric power, lighting, and/or
medical gases and/or liquids, plume evacuation systems, and anaesthetic gas scavenging systems to medical
areas of a healthcare facility
Note 1 to entry: Medical supply units can include medical electrical equipment or medical electrical systems or
parts thereof. Medical supply units can also consist of modular sections for electrical supply, lighting for therapy or
illumination, communication, supply of medical gases and liquids, plume evacuation systems, and anaesthetic gas
scavenging systems. Some typical examples of medical supply units are bed head services modules, ceiling pendants,
beams, booms, columns, pillars, cabinetry, concealed compartments on or in a wall, and prefabricated walls.
Note 2 to entry: Examples of configurations are given in ISO 11197:2019, Figures 201.103, 201.104 and 201.105.
[SOURCE: ISO 11197:2019, 201.3.201]
3.19
mobile
term referring to transportable equipment that, once installed and placed into service, is intended to be
moved from one location to another while supported by its own wheels or equivalent means
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.65]
3.20
mobility diameter
diameter of a spherical particle with the same electrical mobility as the (potentially non-spherical) particle
in question
[SOURCE: ISO 28439:2011, 3.3 — modified]
3.21
operations management
process for infrastructure maintenance, monitoring and event management
[SOURCE: ISO/IEC TS 22237-7:2018, 3.1.14]
3.22
passive PES
PES whose plume evacuation is accomplished through endoscopic or laparoscopic ports by internal pressure
3.23
pipeline system
portion of a centralised PES between the terminal unit(s) and the supply system
3.24
plume
noxious airborne contaminants generated as by-products, particularly by procedures that rely on the
ablation, cauterization, mechanical manipulation, or thermal desiccation of target tissue by devices such
as lasers, electrosurgical or electrocautery devices, broadband light sources, ultrasonic instruments, or
surgical tools such as bone saws, high speed drills, and reamers
Note 1 to entry: Plume can include visible or invisible aerosol particles, smoke, or gases.
3.25
plume evacuation system
PES
device for capturing, transporting, and filtering plume and exhausting the filtered product
Note 1 to entry: Plume evacuation systems can also be called smoke evacuators, laser plume evacuators, plume
scavengers, and local exhaust ventilators (LEVs).

ISO 16571:2024(en)
3.26
portable
term referring to transportable equipment that, once installed and placed into service, is intended to be
moved from one location to another while being carried by one or more persons
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.85]
3.27
pre-filter
device intended to protect filtration equipment from damage by preventing the intake of large particles
and/or moisture
3.28
simple terminal
PES pipeline end points to which other devices (filters, flow controls, etc.) will connect. They are typically
valves which are open when connected and closed when disconnected
3.29
single fault condition
condition of equipment in which a single means for reducing a risk is defective or a single abnormal condition
is present
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.116]
3.30
single use
referring to a product intended to be used once and then discarded
3.31
source of supply
portion of the supply system with associated control equipment which supplies the pipeline system
[SOURCE: ISO 7396-1:2016, 3.62]
3.32
stationary plume evacuation system
PES
permanently installed PES which is part of the infrastructure of the building and includes a supply system, a
pipeline system, and terminal unit(s), and that conveys the plume to the outside of the building
3.33
supply system
assembly which supplies the pipeline system and which includes all sources of supply
[SOURCE: ISO 7396-1:2016, 3.64]
3.34
terminal unit
inlet assembly in a plume evacuation pipeline system at which the operator makes connections and
disconnections
[SOURCE: ISO 9170-1:2017, 3.18 — modified: adapted for plume evacuation systems]
3.35
transfer tubing
tubing or hose connecting the capture device to the filtration subsystem. Where no other device is used, the
transfer tube may also act as the capture device
3.36
transport air
air moving through a test apparatus intended to carry test aerosol past a sampling probe

ISO 16571:2024(en)
3.37
transportable
term referring to equipment that, once installed and placed into service, is intended to be moved from one
place to another whether or not connected to a supply and without an appreciable restriction of range
EXAMPLE Mobile equipment and portable equipment.
[SOURCE: IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, 3.130]
3.38
ultra-low penetration air filter
ULPA filter
filter meeting the requirements for ISO 29463-1 Group U
4 General requirements
All pressures in this document are positive gauge pressures, including a descriptor relative to local
atmospheric pressure, and are measured in kPa (see Annex E).
EXAMPLE 1 15 kPa pressure means 15 kPa above local atmospheric pressure.
EXAMPLE 2 15 kPa vacuum means 15 kPa below local atmospheric pressure.
4.1 Components
4.1.1 PESs shall comprise the following:
a) a capture device;
b) a filtration subsystem;
c) a control subsystem;
d) a flow-generator, except for a passive PES.
4.1.2 PESs may include the following:
a) a terminal unit;
b) transfer tubing;
c) an exhaust subsystem.
NOTE The arrangement of these components can vary and a single device can incorporate multiple functions.
4.2 Systems
4.2.1 A PES shall, when installed, extended, modified, commissioned, operated, and maintained in
accordance with the instructions of the manufacturer or designer, present no risks that are not reduced to an
acceptable level using risk management procedures in accordance with ISO 14971 and which are connected
with their intended application, in normal condition and in single fault condition.
NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
situations can remain undetected over a period of time and as a consequence can lead to an unacceptable risk. In
that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control
measures need to be determined within the risk management process to deal with such situations.
Check conformity by inspection of the risk management file.

ISO 16571:2024(en)
4.2.2 Type tests different from those described in this document can be used, if an equivalent degree
of compliance can be demonstrated. However, in the event of dispute, the test arrangements and methods
described in this document shall be used as the reference methods.
4.2.3 Medical gas connections (see A.1 for rationale).
4.2.3.1 PES shall not be connected to medical vacuum. Only active PES may be connected to medical
vacuum pipeline systems. See 7.1 for additional active PES requirements.
4.2.3.2 PES components may only be connected to dedicated plume evacuation pipeline systems when
applicable.
4.2.3.3 PES’s shall not be connected to AGSS or general room ventilation systems.
4.2.3.4 If venturis are used to generate the PES airflow, they shall not be driven with any medical gas.
4.2.4 IEC 62366-1 applies to any medical device components of the PES
Check conformity by inspection of the usability engineering file.
4.2.5 Means should be provided to minimize the risk of liquids and solids from entering the filtration
system and flow-generator (see A.2 for rationale)
4.2.6 The resolution and accuracy of all measuring devices used for testing shall be appropriate for
the values to be measured. All measuring devices used for certification shall be calibrated at appropriate
intervals.
4.3 Capture device
4.3.1 Capture device plume removal efficiency shall be at least 90 % when tested according to Annex C
(see A.3 for rationale). Any manufacturer claiming compliance shall provide the following operating test
conditions in the instructions for use (see E.1.2):
a) capture device distance and orientation with respect to the operative site;
b) capture device settings, if adjustable;
c) minimum flow rate through the capture device, or description of the plume evacuation system required
to generate sufficient flow, including
i) transfer tubing diameter, length and style (or manufacturer’s part number)
ii) quantity and style of connectors
iii) prefilters, ULPA filters and adsorbers
iv) flow-generator with setting(s)
v) exhaust port adapters or extension tubing
d) annular cavity sleeve inner diameter and depth to operative site, if applicable (see Figure C.5);
e) details of any other relevant component not listed above.
4.3.2 Capture devices integrated with monopolar electrosurgical handpieces shall be tested for plume
removal efficiency as a general capture device, at minimum (see Figure C.1).

ISO 16571:2024(en)
4.3.3 Flammability risks shall be considered in capture device material selection.
Check conformity by inspection of the risk management file.
4.3.4 The capture device should include a means to prevent attachment to intact tissue or a means to break
the vacuum (see A.4 for rationale).
4.4 Transfer tubing
Tubing design shall consider restriction and occlusion risk (see A.5 for rationale).
Check conformity by inspection of the risk management file.
4.5 Filtration subsystem
4.5.1 The filtration subsystem shall comprise a particulate filter assembly that provides ultra-low
3)
penetration air (ULPA) filter efficiency per ISO 29463-1:— , Table 1 as a minimum, and can include a pre-
filter and/or an adsorber.
Check conformity by visual inspection and inspection of the technical file.
4.5.2 Means shall be provided to indicate when a filtration subsystem change is required. If filtration
subsystems lose effectiveness over time, the PES shall indicate when filtration subsystem components should
be replaced through either markings or audio or visual indications.
Check conformity by visual inspection.
4.5.3 The filtration subsystem shall be designed such that a user is not required to touch a biohazardous
surface during filter removal and installation (i.e., the user should not be directly in contact with the
contaminated filter components).
Check conformity by visual inspection.
4.5.4 The filtration subsystem shall contain an adsorber when the outlet flow is into the operating room.
4.6 Control subsystem
Control subsystem:
a) shall include an ON-OFF device;
b) shall enable user-adjustable flow control from zero (OFF) to maximum.
Check conformance by visual inspection.
NOTE A wide range of control devices (e.g. electronic footswitches, pneumatic footswitches, sensor devices, and
direct cable connections) can be used with PESs. A remote-control feature can be coupled with the activation device of
the laser or electrosurgical unit.
4.7 Flow-generator
Provided that unacceptable risk is not introduced, and the PES continues to meet the requirements of this
document, the flow-generating device can be used to power other systems.
Check conformity by inspection of the risk management file.
NOTE The flow-generating device is usually used only to power the plume evacuation system.
3) Under preparation. Stage at the time of publication: ISO/FDIS 29463-1:2024.

ISO 16571:2024(en)
4.8 Exhaust subsystem
Exhaust subsystem:
a) shall be marked with the symbol ISO 7000-1605, Exhaust gas;
b) should be designed to reduce the risk of blockage;
Check conformity by inspection of the technical and risk management files.
4.9 Colour coding
If colour coding is used, they shall comply with Annex D.
NOTE Markings and/or colour coding can be required based on the manufacturer’s risk management or usability
engineering.
5 Portable and mobile system requirements
5.1 General requirements
Portable and mobile plume evacuation systems shall comply with the applicable requirements for basic safety
and essential performance specified in IEC 60601-1.
5.2 Acoustic noise test
5.2.1 The intent of this testing is to understand noise from the flow-generator with a filtration subsystem.
Variations in system designs shall be taken into consideration in the design of the test.
4)
5.2.2 Acoustic testing shall be conducted in accordance with ISO 3744:— .
5.2.3 Verify that the time-averaged sound pressure level of the background noise is at least 6 dB below the
PES under test, per ISO 3744:—, 4.4.1.
5.2.4 Testing shall include at least 10 positions distributed about the hemisphere described in ISO 3744:—,
Figure B.1. To avoid near field issues, the measurement radius r shall be twice the characteristic source
dimension, d , and not less than 1 m. Typically, the reflecting plane for mobile PES devices will be the test
o
environment floor. For portable PES devices, the reflecting plane shall be the standard test table described in
5.2.6. The 10 positions should be evenly distributed about the hemispherical measurement surface.
5.2.5 The PES device shall be operated in the worst case setting for acoustic noise. Further, the
measurement duration shall be 30 s and include PES device operation through the least favourable condition
for a given setting to simulate real-world use cases.
5.2.6 For a mobile PES device, it should be positioned in the centre of the test environment (see Figure 5.1).
Attach the most favourable transfer tubing size with respect to noise that can be normally applied (e.g.
22 mm × 1,8 m long smooth bore flexible tubing) to the PES device. The transfer tubing shall be routed such
that the noise generated by it is minimized. This should be handled by routing the transfer tubing inlet to the
outside of the test chamber. A transfer tubing extension may be applied to reach outside the test chamber.
Otherwise, for both laboratory or outdoor testing, the transfer tubing inlet may be routed into a muffler as
described in Annex F at a minimum distance of 3 m from the geometric centre of the PES device.
5.2.7 For a portable PES device, it shall be positioned on a standard test table like that represented in
the example shown in Figure 5.2. The standard test table shall conform to ISO 7779:2018, Annex A. This
4) Under preparation. Stage at the time of publication: ISO/FDIS 3744:2024.

ISO 16571:2024(en)
arrangement should then be positioned in the centre of the test environment (see example setup illustration
in Figure 5.1). Attach the most favourable transfer tubing size with respect to noise that can normally be
applied (e.g. 22 mm × 1,8 m long, smooth bore flexible tubing) to the PES device. The transfer tubing shall
be routed such that the noise generated by it is minimized. This should be handled by routing the transfer
tubing inlet to the outside of the test chamber. A transfer tubing extension may be applied to reach outside
the test chamber.
Otherwise, for both laboratory or outdoor testing, the transfer tubing inlet may be routed into a muffler, as
described in Annex F, placed under the test table as shown in the setup example of Figure 5.2.
Key
1 reference box for PES device under test 4 sound chamber pass-through
2 transfer tubing 5 hemi-anechoic sound chamber
3 transfer tubing extension 6 measurement hemisphere perimeter
7 measurement Radius r
Figure 5.1 — Mobile PES positioned in test environment

ISO 16571:2024(en)
a) Example standard test table b) Example portable PES positioned in test envi-
based on ISO 7779:2018, Annex A ronment on test table and with a muffler
Figure 5.2 — Example of standard test table set up
5.2.8 Calculate the A-weighted sound pressure level averaged over the measurement surface according to
ISO 3744:—, 8.2.2.
5.2.9 The instructions for use shall state the sound pressure level calculated in 5.2.7 and associated flow-
generator setting.
5.3 Ingress protection
Enclosures of portable and mobile plume evacuation systems shall provide at least an IP21 degree of protection
(see A.6 for rationale).
Conformity shall be checked per IEC 60529.
6 Stationary and pipeline system requirements
6.1 Stationary plume evacuation systems
6.1.1 Subclause 6.1 shall be applicable to any plume system where the flow-generator(s) are mounted to or
in the building structure or on or in a medical supply unit, such that tubing and/or a pipeline and termi
...