T-CSTM 00387E-2021 英文版 复用式日常防护口罩

ICS59.080.30CCSW55

T/CSTM00387E—2021

Reusabledailyprotectivemask

复用式日常防护口罩

(EnglishTranslation)

Issueddate:2021-12-03Implementationdate：2022-03-03

IssuedbyChineseSocietyforTesting&Materials，Zhongguancun

T/CSTM00387E-2021

Foreword

ThisEnglishdocumentwastranslatedfromT/CSTM00387-2020byCSTM/FC99(TheintegratedfieldtechnicalcommitteeofChineseSocietyforTesting&Materials).IncaseofanydoubtaboutthecontentsofEnglishtranslation,theChineseoriginalshallbeconsideredauthoritative.

ThisdocumentisdraftedinaccordancewiththerulesgiveninGB/T1.1-2020(Directivesforstandardization-Part1:Rulesforthestructureanddraftingofstandardizingdocuments).

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.Theissuingbodyofthisdocumentshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.

ThisdocumentwasproposedbyCSTM/FC99(TheintegratedfieldtechnicalcommitteeofChineseSocietyforTesting&Materials).

ThisdocumentwaspreparedbyCSTM/FC99(TheintegratedfieldtechnicalcommitteeofChineseSocietyforTesting&Materials).

T/CSTM00387E-2021

Reusabledailyprotectivemask

1Scope

Thisdocumentspecifiesthetermsanddefinitions,classification,technicalrequirements,testmethod,inspectionrules,packaging,marking,storageandtransportofreusabledailyprotectivemask.

Thisdocumentisapplicabletoreusableprotectivemaskwhichwearsindailylifetofilterparticleintheairandblockdust,smoke,droplet,microorganisms,pollen,catkins,etc.

Thisdocumentisnotapplicabletorespiratoryprotectiveequipmentwhichuseintheconditionsofanaerobicenvironment,underwateroperation,escape,firefighting,medicaltreatmentorotherspecialindustries.

Thisdocumentisnotapplicabletorespiratormaskforinfantsandchildren.

2Normativereferences

Thefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.

GB2890-2009Respiratoryprotection-Non-poweredair-purifyingrespirators

GB/T2912.1Textiles-Determinationofformaldehyde-Part1:Freeandhydrolyzedformaldehyde(waterextractionmethod)

GB/T7573Textiles-DeterminationofpHofaqueousextract

GB/T14233.1-2008Testmethodsforinfusion,transfusion,injectionequipmentsformedicaluse-Part1:Chemicalanalysismethods

GB15979-2002Hygienicstandardfordisposablesanitaryproducts

GB/T17592Textiles-Determinationofthebannedazocolourants

GB/T29865Textiles-Testsforcolourfastness-Colourfastnesstorubbing-SmallareasGB/T32610-2016Technicalspecificationofdailyprotectivemask

GB/T38413-2019Textiles-Testmethodsforfiltrationofparticulatematter

3Termsanddefinitions

Forthepurposesofthisdocument,thetermsanddefinitionsgiveninGB/T18664-2002,GB/T38413-2019andthefollowingapply.Foreaseofuse,thefollowingalsoincludesthetermsanddefinitionsinGB/T18664-2002andGB/T38413-2019.

3.1

particle

T/CSTM00387E-2021

particularmatterthatsuspendedintheairintheformofsolid,liquidorsolid-liquid(i.e.dust,smoke,fog,microorganism)

[Source:GB/T18664-2002,3.1.15]

3.2

particulatematter

PM2.5

particularmatterthathaveanaerodynamicequivalentdiameterof2.5μmorlessinambientair[Source:GB/T38413-2019,3.1]

3.3

filtrationefficiency

abilityofthemaskmaterialtofilteroutparticulatematterunderspecifiedtestconditions(expressedaspercentages)

[Source:GB/T32610—2016,3.2]

3.4

filtrationresistance

staticpressuredifferencebeforeandaftermaskfiltrationunderspecifiedtestconditions[Source:GB/T38413-2019,3.3]

3.5

articleprotectiveperformance

abilityofthemasktofilterparticulatematterunderspecifiedtestconditions(expressedaspercentages)[Source:GB/T32610—2016,3.3]

4Classification

Accordingtotheusage,reusabledailyprotectivemasksaredividedintoreusablePM2.5dailyprotectivemaskandreusableordinarydailyprotectivemask.

5Technicalrequirements

5.1Generalrequirements

5.1.1Themaskshallbeabletocovertheuser’snoseandmouthandshallhavegoodtightness.

5.1.2Themaskshallbenopeculiarsmell,allrawmaterialsofthemaskshallbeharmlesstopeople.

5.1.3Themaskshallnothaveanysharpedgesortips,andshallnotcauseinjurytotheuser.

5.1.4Themaskshallbeeasytowearandtakeoff,havenoobviousconstrictionortendernessduringuse,themaskshallnothavenoticeableeffecttoheadmovements.

T/CSTM00387E-2021

Note:Themanufacturermayensurethattheproductmeetsthegeneralrequirementsbyacceptingtheinspectionorprovidingatestreport.

5.2Appearancequalityrequirement

Thesurfaceofthemaskshallnothavedamage,oilstain,deformationandotherobviousdefects.Formaskswithexhalationvalve,theexhalationvalveshallnotbevisiblybrokenorabouttofalloff.

5.3Internalqualityrequirements

InternalqualityrequirementsseeTable1.

Table1Internalquality

Items

Requirements

ReusablePM2.5dailyprotectivemask

Reusableordinarydailyprotectivemask

Filtrationefficiencyofparticulatematter/%

≥95

≥90

Particleprotectiveperformance/%

≥85

—

Inhalationresistance/Pa

≤210（21mmH2O）

—

Exhalationresistance/Pa

≤210（21mmH2O）

—

Filtrationresistance/Pa

—

≤160（16mmH2O）

Breakingstrengthofmaskbandandthejointofmaskbandandmaskbody/N

≥20

Fastnessofexhalationvalvea

Noslippage,fractureanddeformation

Microorganism

Coliform

Shallnotbedetected

PseudomonasAeruginosa,StaphylococcusAureusandStreptococcusHemolyticus

Shallnotbedetected

Totalfungal

colonies/（cfu/g）

≤100

Totalbacterial

colonies/（cfu/g）

≤200

Colorfastnesstodryrubbingb/level

≥4

Colorfastnesstowetrubbingc/level

≥4

T/CSTM00387E-2021

pHValue

4.0~8.5

Formaldehydecontent/（mg/kg）

≤20

Decomposablecarcinogenic

aromaticaminedyesb,c/（mg/kg）

Forbidden

Residualquantityofepoxyethaned/(μg/g）

≤10

Visualfielde

Lowervisualfield

≥35°

Binocular

visualfield

≥65%

aOnlythemaskwithexhalationvalveareassessed.

bOnlythedyeingandprintingpartsoftheouterlayerofthemaskareassessed.

COnlythedyeingandprintingpartsoftheinnerlayerofthemaskareassessed.

dOnlymaskstreatedwithethyleneoxideareassessed.eOnlythree-dimensionmasksareassessed.

5.4Reuserequirement

5.4.1Appearancequality

Afterprocessingunderthereusemethodandreusablenumberoftimesprovidedbythemanufacturer,appearancequalityshallmeettherequirementof5.2.

5.4.2Innerquality

5.4.2.1ReusablePM2.5dailyprotectivemask

Afterprocessingunderthereusemethodandreusablenumberoftimesprovidedbythemanufacturer,filtrationefficiencyofparticulatemattershallbe90%orover,theparticleprotectiveperformance,exhalationresistance,inhalationresistance,breakingstrengthofmaskbandandthejointofmaskbandandmaskbody,fastnessofexhalationvalve,andmicrobiologicalindicatorsshallmeetthecorrespondingrequirementsinTable1.

5.4.2.2Reusableordinarydailyprotectivemask

Afterprocessingunderthereusemethodandreusablenumberoftimesprovidedbythemanufacturer,filtrationefficiencyofparticulatemattershallbe85%orover,thefiltrationresistance,breakingstrengthofmaskbandandthejointofmaskbandandmaskbody,fastnessofexhalationvalve,andmicrobiologicalindicatorsshallmeetthecorrespondingrequirementsinTable1.

T/CSTM00387E-2021

6Testmethod

6.1Reusetreatment

Themaskshallbetreatedunderthereusemethodandthereusablenumberoftimesidentifiedbythemaskmanufacturer.

AnnexAshowsseveralreusemethodsforreference.

6.2Appearanceinspection

Take10maskstocarryoutthevisualinspection.Theinspectionlightshouldbenormalnaturallight;ifadoptingfluorescentlighting,theilluminationshouldnotbelessthan400lx.

6.3Filtrationefficiencyofparticulatematter

6.3.1Samplequantityandrequirements

Take9masks,amongthem,3masksamplesshallnotprocessanypretreatment,3masksamplesshallprocesshumidityandtemperaturetreatmentaccordingto7.2inGB/T38413-2019and3masksamplesshallbereusetreatedaccordingto6.1.

6.3.2Inspectionmethod

TheinspectionshallbeperformedinaccordancewiththerulesgiveninGB/T38413-2019.Photometerwithoutscabbardgasprotectionisalsoapplicablewhenitcouldmeetthemeasurementrangeandaccuracy.Setthegasflowat85L/min,andthetestmediumissodiumchloride(NaCl)particles.ForreusablePM2.5dailyprotectivemask,itshalltesttheloadingfiltrationefficiency,andtheloadingmassis30mg.Forreusableordinarydailyprotectivemask,itshalltestthenotloadedfiltrationefficiency(Namely,thepre-testfiltrationefficiencytestedin9.3.1.2ofGB/T38413-2019).

6.3.3ResultCalculation

6.3.3.1Initial

Calculatetheaveragefiltrationefficiencyof3sampleswithoutpretreatmentand3sampleswithpretreatmentofhumidityandtemperatureseparately,andtakesmallervalueasthetestresult.

6.3.3.2Reuse

Taketheaveragefiltrationefficiencyof3reusetreatedsamplesastestresult.

T/CSTM00387E-2021

6.4Particleprotectiveperformance

6.4.1Samplequantityandrequirements

Take9masks,3masksamplesshallnotprocessanypretreatment,3masksamplesshallprocesshumidityandtemperaturepretreatmentaccordingto7.2inGB/T38413-2019,and3masksamplesshallbereusetreatedaccordingto6.1.

6.4.2Inspectionmethod

TheinspectionshallbeperformedinaccordancewiththeAnnexBinGB/T32610-2016.Thetestmediumissodiumchloride(NaCl)particles.

6.4.3ResultCalculation

6.4.3.1Initial

Calculatetheaverageparticleprotectiveperformanceof3sampleswithoutpretreatmentand3sampleswithpretreatmentofhumidityandtemperatureseparately,andtakesmallervalueasthetestresult.

6.4.3.2Reuse

Taketheaverageparticleprotectiveperformanceof3reusetreatedsamplesastestresult.

6.5Inhalationresistanceandexhalationresistance

6.5.1Samplequantityandrequirements

Take9masks,3masksamplesshallnotprocessanypretreatment,3masksamplesshallprocesshumidityandtemperaturepretreatmentaccordingto7.2inGB/T38413-2019,and3masksamplesshallbereusetreatedaccordingto6.1.

6.5.2Inspectionmethod

TheinspectionshallbeperformedinaccordancewiththerulesinGB/T32610-2016,6.7,6.8.

6.5.3ResultCalculation

6.5.3.1Initial

T/CSTM00387E-2021

Calculatetheaverageinhalationresistanceandexhalationresistanceof3sampleswithoutpretreatmentand3sampleswithpretreatmentofhumidityandtemperatureseparately,andtakebiggervalueasthetestresult.

6.5.3.2Reuse

Taketheaverageinhalationresistanceandexhalationresistanceof3reusetreatedsamplesastestresult.

6.6Filtrationresistance

6.6.1Samplequantityandrequirements

Take9masks,3masksamplesshallnotprocessanypretreatment,3masksamplesshallprocesshumidityandtemperaturepretreatmentaccordingto7.2inGB/T38413-2019,and3masksamplesshallbereusetreatedaccordingto6.1.

6.6.2Inspectionmethod

TheinspectionshallbeperformedinaccordancewiththerulesgiveninGB/T38413-2019.Setthegasflowat85L/min,thetestmediumissodiumchloride(NaCl)particles.Testtheinitialresistance.

6.6.3ResultCalculation

6.6.3.1Initial

Calculatetheaverageinitialresistanceof3sampleswithoutpretreatmentand3sampleswithpretreatmentofhumidityandtemperatureseparately,andtakebiggervalueasthetestresult.

6.6.3.2Reuse

Taketheaverageinitialresistanceof3reusetreatedsamplesastestresult.

6.7Breakingstrengthofmaskbandandthejointofmaskbandandmaskbody

6.7.1Samplequantityandrequirements

Take9masks,3masksamplesshallnotprocessanypretreatment,3masksamplesshallprocesshumidityandtemperaturepretreatmentaccordingto7.2inGB/T38413-2019and3masksamplesshallbereusetreatedaccordingto6.1.

6.7.2Inspectionmethod

T/CSTM00387E-2021

TheinspectionshallbeperformedinaccordancewiththerulesinGB/T32610-2016,6.9.

6.7.3Resultpresentationandcalculation

6.7.3.1Resultpresentation

Calculatethebreakingstrengthoftwobandsoneachsample,andtakesmallervalueasthetestresult.

6.7.3.2ResultCalculation

6.7.3.2.1Initial

Calculatetheaveragebreakingstrengthof3sampleswithoutpretreatmentand3sampleswithpretreatmentofhumidityandtemperatureseparately,adtakesmallervalueasthetestresult.

6.7.3.2.2Reuse

Taketheaveragebreakingstrengthof3reusetreatedsamplesastestresult.

6.8Fastnessofexhalationvalve

ThetestoffastnessofexhalationvalveshallbeperformedinaccordancewiththerulesgiveninGB/T32610-2016,6.10.

6.9Microbiologicalindicator

ThetestofmicrobiologicalindicatorshallbeperformedinaccordancewiththeAnnexBinGB15979-2002.

6.10Colorfastnesstorubbing

ThetestofcolorfastnesstorubbingshallbeperformedinaccordancewiththerulesgiveninGB/T29865.Thesampleofcolorfastnesstodryrubbingiscutfromtheouterlayerofthemask,andthecolorfastnesstowetrubbingiscutfromthecontactlayerbetweenthemaskandface.

6.11pHvalue

ThetestofpHvalueshallbeperformedinaccordancewiththerulesgiveninGB/T7573.ThesampleofpHvalueiscutfromthecontactlayerbetweenthemaskandface.

6.12FormaldehydeContent

T/CSTM00387E-2021

ThetestofformaldehydecontentshallbeperformedinaccordancewiththerulesgiveninGB/T2912.1.

6.13Decomposablecarcinogenicaromaticaminedyes

ThetestofdecomposablecarcinogenicaromaticaminedyesshallbeperformedinaccordancewiththerulesgiveninGB/T17592.

6.14Residualquantityofepoxyethane

ThetestofresidualquantityofepoxyethaneshallbeperformedinaccordancewiththerulesofClause9giveninGB/T14233.1—2008.Takeparallelsamplesfortesting,andcutthesamplesfromthebodyofthemask.Ifoneofthetestresultsisqualifiedandtheotherisunqualified,theaveragecalculationshallnotbeallowed.Weshalltakesamplesandtestagainandadoptthehighestvalueasthetestresults.Theresultsareexpressedintermsofrelativecontentwithonedecimalplacereserved.

6.15Visualfield

ThetestofvisualfieldshallbeperformedinaccordancewiththerulesgiveninGB2890—2009,6.8.

7InspectionRules

7.1Sampling

Productsofthesamevarietyandspecification(model)withthesamedeliverybatchnumbershallberegardedasaninspectionlot.Thecorrespondingnumberofsamplesshallberandomlyselectedfromeachinspectionlotaccordingtothetestrequirements,andthisnumbershallatleastmeettherequirementsofvarioustestsinClause6.Whenthedeliveryquantityofthesamedeliverybatchismorethan100,000,thesamplingnumbershallbedoubled.

7.2Qualityevaluation

7.2.1Evaluationofappearancequality

Thetestofappearancequalityshallbeperformedinaccordancewiththerulesgivenin6.2,atleast8ormoresamplesshallmeettherequirementsof5.2and5.4.1,otherwisenotqualified.

7.2.2Evaluationofinternalquality

Theinternalqualityshallmeettherequirementsof5.3and5.4.2,otherwisenotqualified.

7.2.3Resultevaluation

T/CSTM00387E-2021

Iftheappearancequalityandinternalqualitybotharequalified,thisbatchofproductscanbeevaluatedasqualified,otherwisenotqualified.

8Packaging,label,storageandtransport

8.1Packaging

Themasksshallbeofferedforsalepackagedinsuchawaythattheyarewellsealedandtakenouteasily.Themasksshallbeprotectedagainstcontaminationbeforeuse.

8.2Label

Theminimumsalespackageshallbeprovidedwithqualifiedinspectionmarksandclearlyidentifiablelabelwhichshallincludebutnotlimitedtothefollowing:

a)Nameandaddressofthemanufacturer;

b)Productname(reusablePM2.5dailyprotectivemaskorreusableordinarydailyprotectivemask);

c)Mainrawmaterials;

d)Executivestandardnumber;

e)Theprocessingmethodofproductreuse;

f)Reusabletimes;

g)Productspecifications(suchassmall,medium,largeorsize,etc.);

h)Instructionsforuse(wearingmethod,precautions,etc.);

i)Productiondateandstorageperiod;

j)Ifdisinfectionmethodisadopted,thedisinfectionmethodshallbeindicated.

8.3Storage&Transport

Duringstorageandtransport,theproductsshallbesealed,freefromdamage,contaminationanddamp,andattentionshallbepaidtofire,rain,acidandalkali,andavoiddirectsunlight.

T/CSTM00387E-2021

AnnexA

Processingmethodofreuse

（Informative）

A.1Soakingwith75%medicalalcoholmethod

Soakthemaskinthe75%concentrationofmedicalethanolsolution,whichisinaccordancewiththerulesgivenintheGB/T26373Hygienicstandardforalcoholdisinfectants,afteritisfullyinfiltrated,takeitoutanddrynaturally.

A.2Hightemperaturedryingmethod

Placethemaskflatlyin