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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 2024
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ii
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
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
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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
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) PE
...