ISO 16571:2014
(Main)Systems for evacuation of plume generated by medical devices
Systems for evacuation of plume generated by medical devices
ISO 16571:2014 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. ISO 16571:2014 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).
Systèmes de gaz médicaux — Systemes d'évacuation des effluents gazeux générés par l'utilisation de dispositifs medicaux
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INTERNATIONAL ISO
STANDARD 16571
First edition
2014-03-15
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
Reference number
©
ISO 2014
© ISO 2014
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Published in Switzerland
ii © ISO 2014 – All rights reserved
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 5
5 Design requirements . 6
5.1 Components . 6
5.2 Connectors . 6
5.3 Supply system for central plume evacuation . 8
6 Indicating systems . 8
7 Plume extraction system pipeline . 8
7.1 Mechanical integrity . 8
7.2 Pressures and flows . 8
7.3 Shut-off valves . 9
8 System components . 9
8.1 Capture device . 9
8.2 Transfer tubing — Kinking .10
8.3 Filtration system .10
8.4 Flow-generating device .10
8.5 Exhaust system .10
8.6 Control system.11
8.7 Pipelines, tubing, and other components .11
9 Terminal units .11
10 Marking and colour coding .12
10.1 Marking .12
10.2 Colour coding .12
11 Pipeline installation .12
12 Testing, commissioning, and certification of the PES.12
12.1 General requirements for tests .12
12.2 Noise testing .12
12.3 Tests, inspections, and checks of a fixed (local stationary or central) PES .13
12.4 Tests, inspections, and checks of portable and mobile PES .14
13 Information to be supplied by the manufacturer .15
13.1 General .15
13.2 Instructions for use .15
13.3 Operational management information .16
Annex A (informative) Types of plume evacuation systems .17
Annex B (informative) Healthcare facility policies and procedures .23
Annex C (informative) Typical plume capture devices and transfer tubings .26
Annex D (informative) Risk management checklist .27
Annex E (informative) Operational management .28
Annex F (informative) Rationale .29
Annex G (informative) Example of procedure for testing and commissioning for a
central system .30
Annex H (informative) Guidelines for flow-generating devices consisting of fans or blowers .32
Bibliography .33
iv © ISO 2014 – All rights reserved
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
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, electrosurgical
generators, broadband light sources, ultrasonic instruments, etc. or mechanical surgical tools such
as bone saws, high speed drills, and reamers. New technologies in cutting and sealing can result in
[85]
less plume generation (see Reference ) but plume remains a hazard. Energy-based contact with
articles such as tubing, swabs, and skin preparation solutions will produce additional chemicals. This
International Standard 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: viable bacteria (including multi-resistant strains), viruses,
cellular debris (including DNA), airborne chemicals, particulates, ultrafine particles, aerosols, gases,
vapours, and fumes (including fumes from metals). In vitro studies of bacterial and viral contamination
have found viable Escherichia coli, Staphylococcus aureus, human papillomavirus (HPV), hepatitis viruses
(HVB, HVC), and human immunodeficiency virus (HIV) in plume. The gases in plume can include toxic
substances such as benzene, formaldehyde, and hydrogen cyanide. Plume can also contain aerosolized
blood (plasma, cells, or fragments of cells) and blood-borne pathogens.
Plume thus poses a hazard to exposed persons. It can transmit infection, or have mutagenic or carcinogenic
effects. Plume can also cause irritation of the mucous membranes, eyes, respiratory system, and skin.
Additionally, plume reduces the clinician’s ability to clearly see the operative field, resulting in unsafe
operating conditions.
This International Standard 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 International Standard.
This International Standard seeks to ensure that plume generated in healthcare facilities is not
evacuated through the medical vacuum or anaesthetic gas scavenging systems. For this reason, type-
specific components are specified for terminal units
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