1、BSI Standards PublicationBS ISO 16571:2014Systems for evacuation ofplume generated by medicaldevicesBS ISO 16571:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 16571:2014. The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/
2、6, Medical gas supply systems.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institutio
3、n 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 74675 8ICS 11.040.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2014.Amendments/corrigend
4、a issued since publicationDate Text affectedBS ISO 16571:2014 ISO 2014Systems for evacuation of plume generated by medical devicesSystmes de gaz mdicaux Systemes dvacuation des effluents gazeux gnrs par lutilisation de dispositifs medicauxINTERNATIONAL STANDARDISO16571First edition2014-03-15Referenc
5、e numberISO 16571:2014(E)BS ISO 16571:2014ISO 16571:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, i
6、ncluding 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 ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41
7、 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 16571:2014ISO 16571:2014(E) ISO 2014 All rights reserved iiiContents PageForeword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 55 Design requirements 65.1 Compo
8、nents . 65.2 Connectors 65.3 Supply system for central plume evacuation 86 Indicating systems 87 Plume extraction system pipeline 87.1 Mechanical integrity . 87.2 Pressures and flows 87.3 Shut-off valves . 98 System components . 98.1 Capture device . 98.2 Transfer tubing Kinking 108.3 Filtration sys
9、tem . 108.4 Flow-generating device 108.5 Exhaust system 108.6 Control system 118.7 Pipelines, tubing, and other components . 119 Terminal units 1110 Marking and colour coding .1210.1 Marking 1210.2 Colour coding 1211 Pipeline installation .1212 Testing, commissioning, and certification of the PES121
10、2.1 General requirements for tests 1212.2 Noise testing . 1212.3 Tests, inspections, and checks of a fixed (local stationary or central) PES 1312.4 Tests, inspections, and checks of portable and mobile PES 1413 Information to be supplied by the manufacturer 1513.1 General 1513.2 Instructions for use
11、 1513.3 Operational management information . 16Annex A (informative) Types of plume evacuation systems .17Annex B (informative) Healthcare facility policies and procedures 23Annex C (informative) Typical plume capture devices and transfer tubings 26Annex D (informative) Risk management checklist 27A
12、nnex E (informative) Operational management 28Annex F (informative) Rationale 29Annex G (informative) Example of procedure for testing and commissioning for a central system 30BS ISO 16571:2014ISO 16571:2014(E)iv ISO 2014 All rights reservedAnnex H (informative) Guidelines for flow-generating device
13、s consisting of fans or blowers .32Bibliography .33BS ISO 16571:2014ISO 16571:2014(E)ForewordISO (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 thro
14、ugh 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 collabor
15、ates 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 c
16、riteria 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
17、 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 na
18、me 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 ISOs adherence to the WTO principles in the Technic
19、al Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. ISO 2014 All rights reserved vBS ISO 16571:2014ISO 16571:2014(E)Introduction
20、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, electrosurgi
21、cal 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 less plume generation (see Reference85) but plume remains a hazard. Energy-based contact with ar
22、ticles 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
23、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 v
24、iable 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 (pla
25、sma, 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 th
26、e clinicians 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, inspecti
27、on, 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
28、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 and for other connectors which are intended to be used by the operator.The objectives of this Interna
29、tional Standard are to ensure the following:a) non-interchangeability with other products or pipeline systems by design;b) continuous extraction at specified pressures and flows;c) use of suitable materials for all components of the system;d) provision of monitoring indicators and alarm systems;e) c
30、orrect rating of filtration systems;f) correct indication of filter life;g) correct marking and labelling;h) electrical and environmental testing;i) correct installation;j) testing, commissioning, and certification;k) provision of guidance on operational management;l) appropriate manufacturers instr
31、uctions for use, training, service, and maintenance.vi ISO 2014 All rights reservedBS ISO 16571:2014ISO 16571:2014(E)Annex F contains rationale statements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning that led to the requ
32、irements and recommendations that have been incorporated into this International Standard. The clauses and subclauses marked with * after their number have corresponding rationale contained in Annex F. It is considered that knowledge of the reasons for the requirements will not only facilitate the p
33、roper application of this International Standard, but will expedite any subsequent revisions. ISO 2014 All rights reserved viiBS ISO 16571:2014BS ISO 16571:2014Systems for evacuation of plume generated by medical devices1 Scope1.1 This International Standard specifies requirements and guidelines for
34、 the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices.NOTE A plume evacuation system (PES) can be a functionally independent component of a medical device that
35、 has other functions.1.2 This International Standard is applicable toa) portable and mobile plume evacuation systems,b) local stationary plume evacuation systems,c) dedicated central pipeline systems for plume evacuation systems, andd) plume evacuation systems integrated into other equipment (e.g. l
36、aser equipment).1.3* This International Standard does not apply to active and passive devices used to evacuate plume generated during invasive (e.g. laparoscopic or endoscopic) procedures.1.4 This International Standard does not apply to the following:a) anaesthetic gas scavenging systems (AGSSs) wh
37、ich 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;NOTE Some other aspects of laser safety are covered by IEC 60825 (see Reference7).e) aspec
38、ts of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are
39、 indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3744:2010, Acoustics Determination of sound power levels and sound energy levels of noise sources usi
40、ng sound pressure Engineering methods for an essentially free field over a reflecting planeISO 5359, Low-pressure hose assemblies for use with medical gasesISO 7396-1:2007, Medical gas pipeline systems Part 1: Pipelines for compressed medical gases and vacuumISO 11197, Medical supply unitsISO 14971,
41、 Medical devices Application of risk management to medical devicesINTERNATIONAL STANDARD ISO 16571:2014(E) ISO 2014 All rights reserved 1BS ISO 16571:2014ISO 16571:2014(E)IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC 61672-1, Ele
42、ctroacoustics Sound level meters Part 1: SpecificationsIEC 62366, Medical devices Application of usability engineering to medical devicesEN 1041, Information supplied by the manufacturer of medical devicesEN 1822-1, High efficiency air filters (HEPA and ULPA) Classification, performance testing, mar
43、kingEN 13348, Copper and copper alloys Seamless, round copper tubes for medical gases or vacuum3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1adsorberdevice that removes volatile organic compounds and odours from a gas streamEXAMPLE Activated c
44、arbon filter.3.2capture devicehose, tube, funnel, or other accessory that provides the inlet to the plume evacuation system at the site of plume generation3.3central plume evacuation systempermanently installed PES which includes a supply system, a pipeline system, and terminal unit(s), and that con
45、veys the plume to the outside of the building3.4diversity factorfactor which represents the maximum proportion of terminal units in a defined clinical area which will be used at the same time, at flow rates defined in agreement with the management of the healthcare facility and according to this Int
46、ernational Standard3.5electrocauterysurgical technique that uses an electrically heated device to cut, ablate, or coagulate tissue for therapeutic purposesNote 1 to entry: Electrosurgery is also known as high frequency (HF) surgery or surgical diathermy.3.6electrosurgerysurgical technique that uses
47、a radiofrequency electric current passing through the patient to cut, ablate, or coagulate tissue for therapeutic purposes3.7flow-generating devicepart of a plume evacuation system that provides flow and vacuum for evacuating plume3.8junction pointconnection point between the inlet tubing to the flo
48、w-generating device and the PES pipelineNote 1 to entry: See Figure A.3.2 ISO 2014 All rights reservedBS ISO 16571:2014ISO 16571:2014(E)3.9local stationary plume evacuation systempermanently installed PES that includes a flow-generating device and terminal unit and that vents the filtered plume insi
49、de the room3.10manufacturernatural or legal person with responsibility for the design, manufacture, packaging, and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party3.11medical deviceany instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic
