BS ISO 16900-12-2016 Respiratory protective devices Methods of test and test equipment Determination of volume-averaged work of breathing and peak respiratory pressures《呼吸保护装置 试验方法.pdf

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1、BS ISO 16900-12:2016Respiratory protective devices Methods of test and testequipmentPart 12: Determination of volume-averagedwork of breathing and peak respiratorypressuresBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS ISO 16900-12:2016 BRITISH STANDARDNational f

2、orewordThis British Standard is the UK implementation of ISO16900-12:2016.The UK participation in its preparation was entrusted to TechnicalCommittee PH/4, Respiratory protection.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does no

3、t purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 78313 5ICS 13.340.30Compliance with a British Standard cannot confer immunity fromlegal oblig

4、ations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 May 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 16900-12:2016 ISO 2016Respiratory protective devices Methods of test and test equipment Part 12

5、: Determination of volume-averaged work of breathing and peak respiratory pressuresAppareils de protection respiratoire Mthodes dessai et quipement dessai Partie 12: Dtermination du travail respiratoire en fonction du volume respiratoire et dtermination des pics de pressions respiratoiresINTERNATION

6、AL STANDARDISO16900-12First edition2016-05-15Reference numberISO 16900-12:2016(E)BS ISO 16900-12:2016ISO 16900-12:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be r

7、eproduced 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 ISOs member body in the country of the reque

8、ster.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 16900-12:2016ISO 16900-12:2016(E)Foreword ivIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Prerequisites 2

9、5 General test requirements . 26 Principle 27 Apparatus . 37.1 Breathing machine/metabolic simulator arrangement 37.2 RPD headform/RPD torso . 37.3 Pressure measurements . 37.4 Volume measurements . 37.5 Data acquisition . 48 Test procedure 49 Calculation of work of breathing (WOB) . 59.1 General .

10、59.2 Calculations 59.2.1 Work of breathing . 59.2.2 Volume averaged pressure 69.2.3 Elastance . 610 Test report . 7Annex A (normative) Application of uncertainty of measurement 8Annex B (informative) Pressure-volume plots and method of calculation of work of breathing 10 ISO 2016 All rights reserved

11、 iiiContents PageBS ISO 16900-12:2016ISO 16900-12:2016(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 through ISO technical committees

12、. 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 Intern

13、ational 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 diffe

14、rent 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

15、 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

16、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 Technical Barriers to Trade (TBT) s

17、ee the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 15, Respiratory protective devices.ISO 16900 consists of the following parts, under the general title Respiratory pro

18、tective devices Methods of test and test equipment: Part 1: Determination of inward leakage Part 2: Determination of breathing resistance Part 3: Determination of particle filter penetration Part 4: Determination of gas filter capacity and migration, desorption and carbon monoxide dynamic testing Pa

19、rt 5: Breathing machine, metabolic simulator, RPD headforms and torso, tools and verification tools Part 6: Mechanical resistance/strength of components and connections Part 7: Practical performance test method Part 8: Measurement of RPD air flow rates of assisted filtering RPD Part 9: Determination

20、 of carbon dioxide content of the inhaled gas Part 10: Resistance to ignition, flame, radiant heat and heat Part 11: Determination of field of vision Part 12: Determination of volume-averaged work of breathing and peak respiratory pressures Part 13: RPD using regenerated breathable gas and special a

21、pplication mining escape RPD: Consolidated test for gas concentration, temperature, humidity, work of breathing, breathing resistance, elastance and durationiv ISO 2016 All rights reservedBS ISO 16900-12:2016ISO 16900-12:2016(E) Part 14: Measurement of sound level ISO 2016 All rights reserved vBS IS

22、O 16900-12:2016ISO 16900-12:2016(E)IntroductionThis part of ISO 16900 is intended as a supplement to the respiratory protective devices (RPD) performance standard. Test methods are specified for complete devices or parts of devices that are intended to comply with the performance standards. If devia

23、tions from the test method given in this part of ISO 16900 are necessary, these deviations will be specified in the performance standards.The following definitions apply in understanding how to implement an ISO International Standard and other normative ISO deliverables (TS, PAS, IWA): “shall” indic

24、ates a requirement; “should” indicates a recommendation; “may” is used to indicate that something is permitted; “can” is used to indicate that something is possible, for example, that an organization or individual is able to do something.3.3.1 of the ISO/IEC Directives, Part 2 (sixth edition, 2011)

25、defines a requirement as an “expression in the content of a document conveying criteria to be fulfilled if compliance with the document is to be claimed and from which no deviation is permitted.”3.3.2 of the ISO/IEC Directives, Part 2 (sixth edition, 2011) defines a recommendation as an “expression

26、in the content of a document conveying that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred, but not necessarily required, or that (in the negative form) a certain possibility or course

27、of action is deprecated, but not prohibited.”vi ISO 2016 All rights reservedBS ISO 16900-12:2016INTERNATIONAL STANDARD ISO 16900-12:2016(E)Respiratory protective devices Methods of test and test equipment Part 12: Determination of volume-averaged work of breathing and peak respiratory pressures1 Sco

28、peThis part of ISO 16900 specifies the test methods for determining the volume-averaged work of breathing and peak respiratory pressures imposed by the respiratory protective device (RPD).Elastic work, elastic physiological effects, and information on physiological effects of work of breathing (WOB)

29、 are specified in ISO 16976-4 and are not included in this test method.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated referenc

30、es, the latest edition of the referenced document (including any amendments) applies.ISO 16972, Respiratory protective devices Terms, definitions, graphical symbols and units of measurementISO 16900-5,1)Respiratory protective devices Methods of test and test equipment Part 5: Breathing machine, meta

31、bolic simulator, RPD headforms and torso, tools and verification tools3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 16972 and the following apply.3.1breathing frequencynumber of breaths taken in a minuteNote 1 to entry: Expressed in breaths per minu

32、te.3.2elastanceEpressure change resulting from a volume changeNote 1 to entry: Expressed in kPa/l.3.3tidal volumeVTsize of a breathNote 1 to entry: Expressed in litres.1) To be published. ISO 2016 All rights reserved 1BS ISO 16900-12:2016ISO 16900-12:2016(E)3.4volume-averaged pressureWOB/VTwork for

33、a breath divided by its tidal volume (3.3)Note 1 to entry: Expressed in kPa.Note 2 to entry: The WOB/VTcan be determined separately for an inspiration, for an expiration, or for a whole breath.4 PrerequisitesThe performance standard shall indicate the conditions of the test. This includes the follow

34、ing:a) number of specimens;b) operating parameters specific to RPD;c) selection and types of support such as RPD headform/torso;d) any prior conditioning or testing;e) minute ventilation;f) temperature(s) at which tests are to be performed.5 General test requirementsUnless otherwise specified, the v

35、alues stated in this part of ISO 16900 are expressed as nominal values. Except for temperature limits, values which are not stated as maxima or minima shall be subject to a tolerance of 5 %. Unless otherwise specified, the ambient temperature for testing shall be between 16 C and 32 C and (50 30) %

36、RH. Any temperature limits specified shall be subject to an accuracy of 1 C.Where the assessment of the pass/fail criterion depends on a measurement, an uncertainty of measurement as specified in Annex A shall be reported.6 PrincipleThe RPD is fitted to a headform/torso and is operated at the manufa

37、cturers minimum condition, unless specified otherwise by the performance standards.The breathing machine or metabolic simulator, as applicable, is operated at a combination of tidal volume and breathing frequency, in accordance with the relevant performance standard. The work of breathing is calcula

38、ted from recorded measurements of volume and pressure. These recordings will also provide peak pressures values.Validation of work of breathing measurements and calculations is performed using the verification orifices as specified in ISO 16900-5.Validation of the correct functioning of the breathin

39、g machine/metabolic simulator is performed using the validation orifices specified in ISO 16900-5. Validation is satisfactory when the WOB calculations give results which are in accordance with the data shown in Table 1.2 ISO 2016 All rights reservedBS ISO 16900-12:2016ISO 16900-12:2016(E)7 Apparatu

40、s7.1 Breathing machine/metabolic simulator arrangementA breathing machine or metabolic simulator meeting the specifications of ISO 16900-5 shall be used. An example of a setup is shown in Figure 1.Key1 headform or other suitable mechanism to hold RPD under test2 breathing machine3 displacement senso

41、r4 pressure pickup in the airway opening5 pressure transducer, if separate from 46 data acquisition deviceNOTE Double-headed arrows and single-headed arrows indicate the motion of the breathing machine piston and the direction of gas flow, respectively.Figure 1 Simplified schematic of a setup to mea

42、sure work of breathing7.2 RPD headform/RPD torsoAppropriate RPD headform/RPD torso, as specified in ISO 16900-5, shall be used. For RPD with respiratory interface Class E (see the performance standards), it can be necessary, depending on the design, to adjust the test setup to simulate the volume ta

43、ken up by the arms and legs of the wearer because it can affect the gas flow management of the RPD. It can be necessary to adapt the RPD to allow placement of sensors and probes.7.3 Pressure measurementsA differential pressure transducer measures the positive and negative pressures relative to ambie

44、nt pressure generated during breathing. This respiratory pressure shall be measured using a pressure pickup in the RPD headform or mouthpiece attachment as specified in ISO 16900-5. The pressure measurement system shall be able to measure at frequencies up to 50 Hz with less than 3 dB damping.7.4 Vo

45、lume measurementsThe volume shall be determined from piston displacement which is measured using a displacement sensor mounted on the breathing machine. ISO 2016 All rights reserved 3BS ISO 16900-12:2016ISO 16900-12:2016(E)7.5 Data acquisitionPressure and volume signals shall be acquired at a minimu

46、m of 100 Hz per channel.8 Test procedure8.1 Use the relevant validation orifices as described in ISO 16900-5 to confirm that the measured work of breathing (WOB) from the test system being used is within the tolerances shown in Table 1.8.2 Fit the respiratory interface or complete RPD, in accordance

47、 with the information supplied by the manufacturer, to the appropriate size of RPD headform/torso, and operate the RPD as given by the prerequisites. The respiratory interface should be sealed to the headform where applicable (tight fitting).8.3 Connect the breathing circuit to the RPD headform/tors

48、o.8.4 If applicable, activate the RPD in accordance with the information supplied by the manufacturer and immediately start the test and operate as specified in Clause 4.8.5 Collect data at minute ventilations as given by the prerequisites. After stabilization, for any 10 consecutive breaths, perfor

49、m ensemble averaging of these breaths, calculate the work of breathing and the peak inspiratory and the peak expiratory pressures.8.6 Remove the RPD from the headform/torso and repeat 8.2 to 8.5 for the required number of test specimens.8.7 Repeat 8.1.Table 1 Volume averaged pressure (WOB/VT) values for the two verification orificesMinute ventilationBreathing frequencyTidal volumeOrifice A Orifice B(VT) WOB/VTMaximum asymmetryaWOB/VTMaximum asymmetryal/min min1l kPa % kPa %10 0,3 10,0 1,0 0,06 0,