Tiêu chuẩn iso 16900 12 2016

© ISO 2016 Respiratory protective devices — Methods of test and test equipment — Part 12 Determination of volume averaged work of breathing and peak respiratory pressures Appareils de protection respi[.]

Respiratory pr otecti ve devic es —

Part 12:

Ap ar ils de protection re spiratoire — Méth des d’essai et

é uipement d’essai —

Partie 12: Déte mination du tra ail r spiratoire en fnction

du v lume re spiratoire et déte mination de s pic s de pr ssions

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

F reword i v

Introduction vi

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms an definitions 1

4 Prereq isites 2

5 General test r equirements 2

6 Principle 2

7 A pparatus 3

7.1 Br eathing machine/meta olc simulator arr ang ement 3

7.2 R PD headform/RPD torso 3

7.3 Pr es ur e measur ement 3

7.4 Volume measurement .3

7.5 Data acq isition 4

8 Test pr oc edure 4

9 Calculation of wor k of br eathing (WOB) 5

9.1 General 5

9.2 Calculations 5

9.2.1 Wor k of breathing

5 9.2.2 Volume a verag ed pr es ure 6

9.2.3 Elastanc 6

10 Test rep r t 7

A nne x A (normative) A pplcation of u c er tainty of me surement 8

A nne x B (informative)Pres ure-v lume plots and metho of calculatio of wor k of breathing 10

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b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly car ied out

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org nizations, g ove nmental an non-g ove nmental, in laison with ISO, also take part in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sponsible for identifying any or al such p t ent right Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction an / r

on the ISO ls of p t ent de larations r c ived ( e www.iso.org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT) se the fol owing URL: F or word - Sup lementary information

The committ ee r sp nsible for this document is ISO/TC 94, Pe s on l s afet y — Protec ti ve clothin a d

eq ipment, Subcommitt ee SC 1 , R es piratory protec ti ve dev ic es

ISO 1 9 0 consis s of the fol owing part , u de the g ene al title R es pirator y protec ti ve dev ic es —

Meth ds o tes t a d tes t eq ipment:

— Part 1: Dete min tio o inward leaka e

— Part 2 : Dete min tio o br athin r s i s ta c e

— Part 3 : Dete min tion o p rticle fite penetratio

— Part 4: Deter mi nat i on o g s fi lter ca aci ty a d mi grat i on, desor pt i on a d carb n mo o i de

d yn mi c test ing

— Part 5: B reathin machine, meta olc s imulator, RPD headfrms a d tors o, to l s a d ve ific atio to l s

— Part 6 : Mecha ic al r s i s ta c e/s tr n th o c omp nent a d c on ec tio s

— Part 7: Prac tic al pe frma c e tes t meth d

— Part 8: Meas ur ment o RPD air flow rates o as s i s ted fite in RPD

— Part 9: Dete min tion o c arb n diox ide c ontent o the in aled g s

— Part 10: R es i s ta c e to ig ition,flame, radia t heat a d heat

— Part 1 : Dete min tio o field o v i s io

— Part 12 : Dete min tio o v lume -a e a ed work o br athin a d peak r s pirator y pr s s ur s

— Part 13: RPD us in r gene ated br ath ble g s a d s pec ial a plc atio minin esc ape RPD: Co s olidated

tes t fr g s c onc entration, tempe atur , h midit y, work o br athin , br athin r s i s ta c e, elas ta c e

a d duratio

— Part 14 : Meas ur ment o s ou d level

This part of ISO 1 9 0 is int en ed as a sup lement t o the r spirat ory prot ective devic s (RPD )

pe formanc s an ard Tes methods ar spe ified for complet e devic s or p rt of devic s that ar

int en ed t o comply with the pe formanc s an ards If deviations from the t es method given in this

p rt of ISO 1 9 0 ar ne es ary, these deviations wi bespe ified in the pe formanc s an ards

The folowing def initions a ply in u de s an ing how t o implement an ISO Int ernational Stan ard an

othe normative ISO delve a les (TS, PAS, IWA):

— “ hal” in icat esa r q ir men

— “ hould” indicat es a r commen ation;

— “ ma ”is used t o in icat e that something is pe mitt ed;

— “can” is used t o in icat e that something is p s ible, for ex mple, that an org nization or in ivid al

is a le t o do something

3.3.1 of the ISO/IEC Dir ctives, Part 2 ( ixth edition, 2 1 ) def ines a r q ir ment as an “ex r s ion in

the cont ent of a document conveying c it eria t o be fulf iled if complanc with the document is t o be

claimed an from w hich no deviation is pe mitt ed.”

3.3.2 of the ISO/IECDir ctives, Part 2 ( ixth edition, 2 1 )defines a r commen ation as an “ex r s ion

in the cont ent of a document conveying that among seve al p s ibi ities, one is r commen ed as

p rticularly suita le, without mentioning or ex clu ing othe s, or that a c rtain course of action is

pr fe r d, but not ne es ariy r q ir d, or that ( in the neg tive form) a c rtain p s ibi ty or course of

action is depr cat ed, but not prohibit ed.”

Respiratory protecti ve devic es — Methods oftest and test

Part 12:

This part of ISO 1 9 0 spe ifies the t es methods for det ermining the volume-a e ag ed work of

br athing an peak r spirat ory pr s ur s imp sed b the r spirat ory prot ective devic (RPD )

Elas ic work, elas ic phy siolo ical efe t , an information on phy siolo ical efe t of work of br athing

(WOB) ar spe ified in ISO 1 976-4 an ar not inclu ed in this t es method

2 Normati ve r eferences

The folowing document , in w hole or in p rt, ar normatively r fe enc d in this document an ar

in ispensa le for it a pl cation F or dat ed r fe enc s, only the edition cit ed a pl es F or u dat ed

r fe enc s, the lat es edition of the r fe enc d document ( inclu ing any amen ment )a pl es

ISO 1 9 2, R es piratory protec tive dev ices — Te ms , de initions, gra hic al sy mb l s a d u it o

meas ur ment

ISO 1 9 0-5,

1)

R es piratory protec ti ve devic es — Meth ds o tes t a d tes t eq ipment — Part 5: B reathin

machine,meta olc s imulator, RPD headfrms a d tors o, to ls a d ve ific ation to ls

3 Terms and definitions

F or the purp ses of this document, the t erms an definitions given in ISO 1 9 2 an the folowing a ply

3.1

bre thing frequency

n mbe of br aths taken in a min t e

Note 1t o entry: Expres ed in bre ths per min t e

3.2

elastance

E

pr s ur chang e r sulting from a v lume chang e

Note 1t o entry: Expres ed in k a l

v lume-averag ed pres ure

WOB /V

T

work for a br ath divided b it tidal v lume (3.3)

Not e 1t o entry: Expres ed in k a

Note 2 to entry: T e W OB/V

Tcan b determined separately for an inspiration, for an e piration, or for a

whole bre th

4 Prerequisites

The pe formanc s an ard shal in icat e the con itions of the t es This inclu es the folowing:

a) n mbe of spe imens;

b) o e ating paramet ers spe ific t o RPD;

c) sele tion an ty es of sup ort such as RPD headform/t orso;

d) any prior con itioning or t es ing;

e) min t e venti ation;

f) t empe atur () at w hich t es s ar t o be pe formed

5 General test requirements

Unles othe wise spe ified, the v alues s ated in this p rt of ISO 1 9 0 ar ex r s ed as nominal v alues

Except for tempe atur lmit , v alues which ar not s ated as ma ima or minima shal be subje t t o a

tole anc of ± % Unles othe wise spe ified, the ambient tempe atur for t es ing shal be betwe n 1 °C

an 3 °C an (5 ± 3 ) % RH Any tempe atur lmit spe ified shal be subje t to an ac uracy of± °C

Whe e the as es ment of the pas / fai c it erion depen s on a measur ment, an u c rtainty of

measur ment as spe if ied in An ex A shal be r p rt ed

6 Principle

The RPD is f itt ed t o a headform/t orso and is o e at ed at the man factur r’ s minimum con ition, u les

spe ified othe wise b the pe formanc s an ards

The br athing machine or meta ol c simulat or, as a pl ca le, is o e at ed at a combination of tidal

v lume an br athing fr q ency, in ac ordanc with the r lev nt pe formanc s andard The work of

br athing is calculat ed from r corded measur ment of v lume an pr s ur These r cordings wi l

also pro ide peak pr s ur s v lues

Valdation of work of br athing measur ment an calculations is pe formed using the ve if ication

orif ic s as spe ified in ISO 1 9 0-5

Valdation of thecor e t u ctioning of the br athing machine /meta olc simulat or is pe formed using

the v ldation orific s spe if ied in ISO 1 9 0-5 Valdation is satis act ory w hen the WOB calculations

give r sult w hich ar in ac ordanc with the data shown in Ta le1

7 A pparatus

7.1 Breathing machine/metabol c simulator arrang ement

A br athing machine or meta olc simulat or me ting the spe ifications of ISO 1 9 0-5shal be used An

ex mple of a setup is shown in Figur 1

Key

1 he dform or other suitable mechanism to hold RPD u der test

2 br eathing machine

3 displacement sensor

4 pr es ure pick p in the airwa y opening

5 pr es ure transd cer, if separate fr om 4

6 data acq isition device

NOTE Double-he ded ar ows an single-he ded ar ows in icat e the motion of the bre thing machine piston

an the direction of g s flow, respectively

Figure 1 Simpl fied s hematic of a setu to me sure wor k of bre thing

7.2 RPD headform/RPD tor so

Ap ro riat e RPD headform/RPD t orso, as spe if ied in ISO 1 9 0-5, shal be used F or RPD with

r spirat ory int erfac Clas E ( e the pe formanc s an ards), it can be ne es ary, depen ing on the

design, t o adjus the t es setup t o simulat e the v lume taken up b the arms an legs of the wear r

be a use it can afe t he g s flow manag ement of the RPD It can be ne es ary t o ada t he RPD t o alow

plac ment of sensors an pro es

7.3 Pres ur e measurements

A dife ential pr s ur transd c r measur s the positive an neg tive pr s ur s r lative t o ambient

pr s ur g ene at ed d ring br athing This r spirat ory pr s ur shal be measur d using a pr s ur

pick p in the RPD headform or mouthpie e at achment as spe ified in ISO 1 9 0-5 The pr s ur

measur ment sy st em shal be a le t o measur at r q encies upt o 5 Hz with les than 3 dB damping

7.4 Volume me sur ements

The v lume shal be det ermined from pist on displac ment w hich is measur d using a displac ment

sensor mount ed on the br athing machine

7.5 Data ac quisition

Pr s ur an v lume signals shal be acq ir d at a minimum of 1 0 Hz pe channel

8 Test pr oc edur e

8.1 Use the r elev nt v ldation orific s as desc ibed in ISO 1 90 -5 to confirm that the measured wor k

of breathing (WOB) fr om the tes sys em being used is within the toleranc s shown in Ta le 1

8.2 Fit the respiratory inte fac or complete R PD, in ac or danc with the information sup led b

the manufactur er, to the a propriate siz of R PD headform/torso, and o erate the R PD as g iven b the

pr er eq isites The r espiratory inte fac should be sealed to the headform wher e a plca le (tight itting )

8.3 C n e t the br eathing cir cuit to the RPD headform/torso

8.4 If a pl ca le, activ te the RPD in ac or danc w ith the information sup led b the man factur er

and immediately start the tes an o erate asspe ified in Clause 4

8.5 C le t data at minute ventilations as g iven b the pr er eq isites A fte stabi zation, for any 1

conse utive br eaths, pe form ensemble a verag ing of these breaths, calculate the wor k of br eathing an

the peak inspiratory and the peak ex piratory pres ur es

8.6 Remo e the RPD from the headform/torso and r epeat 8.2 to 8.5 for the r eq ir ed n mbe of tes

spe imens

8.7 Repeat 8.1

Table 1 — Volume averag ed pres ure (WOB/V

T) values for the two verificatio orifices

Asymmet y is c lculated as the absolute value of the diferenc betw een one an the ratio of pe k e piratory pres ure

an pe k inspiratory pres ure, e pres ed in per c nt

NOTE The verif ication proced re identif ies whether or not the bre thing machine is capa le of delivering

ac epta le work of bre thing results Where work of bre thing results are not within the ac epta le limits, it

in icates a fault in the bre thing machine or meta olic simulat or an pipework Common faults that can cause a

deviation of the work of bre thing results from the values given in Ta le 1 inclu e the fol owing:

— a le k in the system;

— to man sharp b n s or right angle elb ws in the pipework;

— flow restrictions in the pipework;

— incor ect wave form (not sin soidal);

— incor ect calculations

9 Calculation of wor k ofbreathing (WOB)

Work of br athing (WOB) is calculat ed o e the a e ag ed br athing cycles an is calculat ed from the

pr s ur dife enc betwe n the airwa o ening an out ide of theRPD an the v lume

A pr s ur -v lume plot is shown in Figur 2 The volume is plott ed along a is A and the pr s ur is

plott ed along a is B Point C an D r pr sent the v lume at the s art an en of inspiration, i.e p int

of no flow The inspiration fol ow s the lne CGD an the ex iration folow s the l ne DHC The tidal v lume

E volume at he start of inspiration K pe k-to-pe k pr es ur e

F volume at en of inspiration

NOTE T e pres ure at point C is shown as zero, but it can b positive, zero, or ne ative

Figure 2 Typical pres ure-v lume plot for an RPD with flow resistance and elastance

9.2 Calculations

9.2.1 Wor k of breathing

The work of br athing (WOB) is calculat ed separat ely for the inspiration (WOB

in) an the ex iration

9.2.2 Volume averag ed pres ure

Theinspirat ory v lume a e ag ed pr s ur (WOB

in/V

T) is calculat ed as shown in F ormula (2):

V

Theex irat ory volume a e ag ed pr s ur (WOB

e/V

T) is calculat ed as shown in F ormula (3):

V

The t otal v lume a e ag ed pr s ur (WOB/V

T) is calculat ed as the t otal work of br athing divided b

the tidal volume (WOB

tot/V

T) as shown in F rmula (4 ):

V

In Figur 2, p int G isthe lowes pr s ur d ring inspiration Point H is thehighes pr s ur d ring the

ex iration The peak pr s ur d ring an inspiration is the dife enc betwe n the pr s ur s at p int

G an C ( hown as I) The peak pr s ur d ring an ex iration is the dife enc betwe n the pr s ur s

at point H an D ( hown as J) The o e al peak-t o-peak pr s ur (K) is the dife enc betwe n the

pr s ur s at p int Han G

Thetidal v lume, V

T, is calculat ed as shown in F ormula (5):