iec test report form template tecnica ce- 50 kn95_1.pdf · report no.:hx2003014394 page: 9 of 23...

Report No.: HX2003014394

Page: 4 of 23

EN149: 2001 + A1: 2009

Clause Requirement + Test Result - Remark Verdict

5 Classification PParticle filtering half masks areclassified according to their filteringefficiency and their maximum totalinward leakage. There are threeclasses of devices:FFP1,FFP2 andFFP3

FFP2 P

6 Designation PParticle filtering half masks meetingthe requirements of this EuropeanStandard shall be designated

P

7 Requirements P

7.1 General PIn all tests all test samples shall meetthe requirements. P

7.2 Nominal values and tolerances PUnless otherwise specified, thevalues stated in this EuropeanStandard are expressed as nominalvalues. Except for temperature limits,values which are not stated asmaxima or minima shall be subject toa tolerance of±5%.

the ambient temperature fortesting shall be (16-32℃,and the temperature limitsshall be subject to anaccuracy of ±1 ℃.

P

7.3 Visual inspection PThe visual inspection shall alsoinclude the marking and theinformation supplied by themanufacturer.

P

7.4 Packaging PParticle filtering half masks shall beoffered for sale packaged in such away that they are protected againstmechanical damage andcontamination before use.

P

7.5 Material PMaterials used shall be suitable towithstand handling and wear overthe period for which the particlefiltering half mask is designed to beused.

P


Page: 5 of 23

EN149: 2001 + A1: 2009


7.6 Cleaning and disinfecting PIf the particle filtering half mask isdesigned for more than a single shift,the materials used shall withstandthe cleaning and disinfecting agentsrecommended by the manufacturer.

P

7.7 Practical performance PThe particle filtering half mask shallundergo practical performance testsunder realistic conditions. Thesegeneral tests serve the purpose ofchecking the equipment forimperfections that cannot bedetermined by the tests describedelsewhere in this standard.

P

7.8 Finish of parts PParts of the device likely to come intocontact with the wearer shall have nosharp edges or burrs.

P

7.9 Leakage P

7.9.1 Total inward leakage P

The laboratory tests shall indicatethat the particle filtering half maskcan be used by the wearer to protectwith high probability against thepotential hazard to be expected.

P

The total inward leakage consists ofthree components: face sealleakage, exhalation valve leakage (ifexhalation valve fitted) and filterpenetration.For particle filtering half masks fittedin accordance with themanufacturer’s information.

P

Total inward leakage shall be notgreater than : P

25％ for FFP1 N11％ for FFP2 FFP2 P5％ for FFP3 N


Page: 6 of 23

EN149: 2001 + A1: 2009


7.9.2 Penetration of filter material PThe penetration of the filter of theparticle filtering half mask shall meetthe requirements.

Sodiumchloride:AR--0.62%;TC--0.57%;SW--0.56%;MS--0.61%

Paraffin oil:AR—2.1%;TC—2.0%;SW—1.8%;MS—1.9%

P

7.10 Compatibility with skin PMaterials that may come into contactwith the wearer’s skin shall not beknown to be likely to cause irritationor any other adverse effect to health.

P

7.11 Flammability P

The material used shall not present adanger for the wearer and shall notbe of highly flammable nature.

When tested, the particlefiltering half mask shall notburn or not to continue toburn for more than 5 s afterremoval from the flame.

P

7.12 Carbon dioxide content of theinhalation air P

The carbon dioxide content of theinhalation air (dead space) shall notexceed an average of 1.0 % (byvolume).

The carbon dioxide:0.62% P

7.13 Head harness P

The head harness shall be designedso that the particle filtering half maskcan be donned and removed easily.

The head harness isadjustable P

7.14 Field of vision PThe field of vision is acceptable ifdetermined so in practicalperformance tests.

P

7.15 Exhalation valve(s) NA particle filtering half mask mayhave one or more exhalationvalve(s), which shall functioncorrectly in all orientations.

N


Page: 8 of 23

EN149: 2001 + A1: 2009


After clogging the inhalation andexhalation resistances shall notexceed

at 95 l/min continuous flow. P

---FFP1: 3 mbar N---FFP2: 4 mbar P---FFP3: 5 mbar N

7.17.3 Filter penetration PAll types (valved and valveless) ofparticle filtering half masks claimedto meet the clogging requirementshall also meet the penetrationrequirements after the treatment.

P

7.18 Demountable parts PAll demountable parts (if fitted) shallbe readily connected and secured,where possible by hand.

P

8 Testing P

8.1 General P

8.2 Visual inspection PThe visual inspection is carried outwhere appropriate by the test houseprior to laboratory or practicalperformance tests.

P

8.3 Conditioning P

8.3.1 Simulated wearing treatment PConditioning by simulated wearingtreatment shall be carried out . P

8.3.2 Temperature conditioning PExpose the particle filtering halfmasks to the following thermal cycle: P

a) for 24 h to a dry atmosphere of(70±3) ℃; P

b) for 24 h to a temperature of (-30±3)℃; P

and allow to return to roomtemperature for at least 4 h betweenexposures and prior to subsequenttesting.

P


Page: 9 of 23

EN149: 2001 + A1: 2009


8.3.3 Mechanical strength PConditioning shall be done inaccordance with EN 143. P

8.3.4 Flow conditioning NA total of 3 valved particle filteringhalf masks shall be tested, one asreceived and two temperatureconditioned .

N

8.4 Practical performance P

8.4.1 General P

A total of 2 particle filtering halfmasks shall be tested: both asreceived.

All tests shall be carried outby two test subjects atambient temperature andthe test temperature andhumidity shall be recorded.

P

a) head harness comfort; P

b) security of fastenings; P

c) field of vision; Pd) any other comments reported by

the wearer on request. P

8.4.2 Walking test PThe subjects wearing normal workingclothes and wearing the particlefiltering half mask shall walk at aregular rate of6 km/h on a levelcourse. The test shall be continuous,without removal of the particlefiltering half mask,for a period of 10min.

P

8.4.3 Work simulation test PThe particle filtering half mask shallbe tested under conditions which canbe expected during normal use.During this test the followingactivities shall be carried out insimulation of the practical use of theparticle filtering half mask.

The test shall be completedwithin a total working time of20min.

P

a) walking on the level withheadroom of (1.3±0.2) m for 5 min; P


Page: 10 of 23

EN149: 2001 + A1: 2009


b) crawling on the level withheadroom of (0.70±0.05) m for 5min;

P

c) filling a small basket withchippings or other suitablematerial from a hopperwhich stands 1,5 m high andhas an opening at the bottom toallow the contents to beshovelled out and a furtheropening at the top where thebasket full of chippings isreturned.

P

The subject shall stoop or kneel ashe wishes and fill the basket withchippings. He shall then lift thebasket and empty the contents backinto the hopper. This shall be done20 times in 10 min.

P

8.5 Leakage P

8.5.1 General test procedure P

8.5.1.1 Total inward leakage PA total of 10 test specimens shall betested: 5 as received and 5 aftertemperature conditioning .For the test, persons shall beselected who are familiar with usingsuch or similar equipment.A panel of ten clean-shaven personsshall be selected covering thespectrum of facial characteristics oftypical usersIt is to be expected that exceptionallysome persons cannot besatisfactorily fitted with a particlefiltering half mask. Such exceptionalsubjects shall not be used for testingparticle filtering half masks.

The total inward leakageshall be tested using sodiumchloride aerosol. P

8.5.1.2 Test equipment P


Page: 11 of 23

EN149: 2001 + A1: 2009


The test atmosphere shall preferablyenter the top of the enclosurethrough a flow distributor, and bedirected downwards over the head ofthe test subject at a minimum flowrate of 0,12 m/s. The concentrationof the test agent inside the effectiveworking volume shall be checked tobe homogeneous. The flow rateshould be measured close to thesubject’s head.

A level treadmill is requiredcapable of working at 6km/h.

P

8.5.1.3 Test procedure PAsk the test subjects to read themanufacturer’s fitting information andif more than one size of particlefiltering half mask is manufactured,ask the test subject to select the sizedeemed by him to be the mostappropriate. If necessary the testsupervisor shall show the testsubjects how to fit theparticle filtering half mask correctly inaccordance with the fittinginformation.

P

a) Ensure the test atmosphere isOFF. P

b) Place the test subject in theenclosure. Connect up the facepiecesampling probe. Have the testsubject walk at 6 km/h for 2 min.Measure the test agent concentrationinside the particle filtering half maskto establish the background level.

P

c) Obtain a stable reading. P

d) Turn the test atmosphere ON. Pe) The subject shall continue to walkfor a further 2 min or until the testatmosphere has stabilized.

P

f) Whilst still walking the subjectshall perform the following exercises: P

1) walking for 2 min without headmovement or talking; P


Page: 12 of 23

EN149: 2001 + A1: 2009


2) turning head from side to side(approx. 15 times), as if inspectingthe walls of a tunnel for 2 min;

P

3) moving the head up and down(approx. 15 times), as if inspectingthe roof and floor for 2 min;

P

4) reciting the alphabet or an agreedtext out loud as if communicatingwith a colleague for 2 min;

P

5) walking for 2 min without headmovement or talking. P

g) Record P

1) enclosure concentration; P2) the leakage over each exercise

period. P

h) Turn off the test atmosphere andwhen the test agent has cleared fromthe enclosure remove the subject.

P

8.5.2 Method P

8.5.2.1 Principle PThe subject wearing the particlefiltering half mask under test walkson a treadmill over which is anenclosure.sampled and analysed during theinhalation phase of the respiratorycycle to determine the NaCl content.The sample is extracted by punchinga hole inthe particle filtering half mask andinserting a probe through which thesample is drawn. The pressurevariation inside the particle filteringhalf mask is used to actuate achange-over valve so that inhaled aironly is sampled. A second probe isinserted for this purpose.

P

8.5.2.2 Test equipment P

8.5.2.2.1 Aerosol generator P


Page: 13 of 23

EN149: 2001 + A1: 2009


The Nacl aerosol shall begenerated from a 2 % solution ofreagent grade NaCl in distilledwater.

P

The type described should beused.This requires an air flow rate of100 l/min at a pressure of 7 bar. Theatomizer and its housing shall befitted into a duct through which aconstant flow of air is maintained. Itmay be necessary to heat ordehumidify the air in order to obtaincomplete drying of the aerosolparticles.

P

8.5.2.2.2 Test agent PThe mean NaCl concentration withinthe enclosure shall be (8 ±4) mg/m3and the variation throughout theeffective working volume shall be notmore than 10 %. The particle sizedistribution shall be 0,02 mm to 2mm equivalent aerodynamicdiameter with a mass mediandiameter of 0,6 mm.

P

8.5.2.2.3 Flame photometer PA flame photometer shall be used tomeasure the concentration of NaClinside the particle filtering half mask.Essential performancecharacteristics for a suitableinstrument are:

P

a) It should be a flame photometerspecifically designed for the directanalysis of NaCl aerosol;

P

b) It should be capable of measuringconcentrations of NaCl aerosolbetween 15 mg/m3 and 5 ng/m3;

P

c) The total aerosol sample requiredby the photometer should not begreater than 15 l/min;

P

d) The response time of thephotometer, excluding the samplingsystem, should not be greater than500 ms;

P


Page: 14 of 23

EN149: 2001 + A1: 2009


e) It is necessary to reduce theresponse to other elements,particularly carbon, the concentrationof which will vary during thebreathing cycle. This will be achievedby ensuring that the band pass widthof the interference filter is no greaterthan 3 nm and that all necessaryside-band filters are included.

P

8.5.2.2.4 Sample selector NA system is required which willswitch the sample to the photometeronly during the inhalation phase ofthe respiratory cycle. During theexhalation phase clean air shall befed to the photometer. The essentialelements of such asystem are:

N

a) An electrically operated valve witha response time of the order of 100ms. The valve should have theminimum possible dead spacecompatible with straight-through,unrestricted flow when open;

N

b) A pressure sensor which iscapable of detecting a minimumpressure change of approx. 0,05mbar and which can be connected toa probe inserted in the cavity of theparticle filtering half mask.

N

c) An interfacing system to actuatethe valve in response to a signalfrom the pressure sensor;

N

d) timing device to record theproportion of the total respiratorycycle during which sampling tookplace.

N

8.5.2.2.5 Sampling probe P


Page: 15 of 23

EN149: 2001 + A1: 2009


The probe shall be fitted securely inan airtight manner to the particlefiltering half mask as near aspossible to the centre line of theparticle filtering half mask. A multiplehole sampling probe is stronglyrecommended. Measures shall betaken to prevent the influence ofcondensation in the sampling probeon the measurement.

P

8.5.2.2.6 Sample pump PIf no pump is incorporated into thephotometer an adjustableflow pump is used to withdraw an airsample from the particle filtering halfmask under test. This pump is soadjusted as to withdraw a constantflow of 1 l/min from the sampleprobe. Dependent on the type ofphotometer it may be necessary todilute the sample with clean air.

P

8.5.2.2.7 Sampling of enclosure concentration PThe enclosure aerosol concentrationis monitored during the tests using aseparate sampling system, to avoidcontamination of the particle filteringhalf mask sampling lines. It ispreferable to use a separate flamephotometer for this purpose.

P

However, time will then be requiredto allow the photometer to return to aclean background.

P

8.5.2.2.8 Pressure detection probe PA second probe is fitted near to thesample probe and is connected tothe pressure sensor.

P

8.5.2.3 Expression of results PThe leakage P shall be calculatedfrom measurements made over thelast 100 s of each of the exerciseperiods to avoid carry over of resultsfrom one exercise to the other.

P


Page: 16 of 23

EN149: 2001 + A1: 2009


8.6 Flammability P

A total of four particle filtering halfmasks shall be tested: two in thestate as received and two aftertemperature conditioning inaccordance with 8.3.2.The single burner test is carried outaccording to the following procedure.

P

The facepiece is put on a metallicdummy head which is motorizedsuch that it describes a horizontalcircle with a linear speed, measuredat the tip of the nose, of (60 ± 5)mm/s.The head is arranged to pass over apropane burner the position of whichcan be adjusted. By means of asuitable gauge, the distance betweenthe top of the burner, and the lowestpart of the facepiece .

P


Page: 17 of 23

EN149: 2001 + A1: 2009


A burner described in ISO 6941 hasbeen found suitable.With the head turned away from thearea adjacent to the burner, thepropane gas is turned on, thepressure adjusted to between 0,2 barand 0,3 bar and the gas ignited. Bymeans of a needle valve and fineadjustments to the supply pressure,the flame heigt shall be set to (40±4)mm. This is measured with a suitablegauge. The temperature of the flamemeasured at a height of (20 ±2) mmabove the burner tip by means of a1,5 mm diameter mineral insulatedthermocouple probe, shall be(800±50)℃.Failure to meet the temperaturerequirement indicates that a faultsuch as a partially blocked burnerexists.

The test shall be repeated toenable an assessment to bemade of all materials on theexterior of the device.

P

8.7 Carbon dioxide content of theinhalation air P

A total of 3 particle filtering halfmasks shall be tested:all 3 as received.The apparatus consists essentially ofa breathing machine with solenoidvalvescontrolled by the breathing machine,a connector, a CO2 flowmeter and aCO2 analyser.The apparatus subjects the particlefiltering half mask to a respirationcycle by the breathing machine.

P

8.8 Strength of attachment of exhalationvalve housing P

A total of three particle filtering halfmasks shall be P


Page: 18 of 23

EN149: 2001 + A1: 2009


tested: one as received, onetemperature conditioned inaccordance with 8.3.2 and one afterthe test described for mechanicalstrength in EN 143.Mount the particle filtering half masksecurely to a fixture as shown inFigure 9. Apply an axial tensile forceof 10 N to the valve for 10 s, andnote the results.

P

8.9 Breathing Resistance P

8.9.1 Test samples and fixture P

8.9.1.1 Valveless particle filtering half masks PA total of 9 valveless particle filteringhalf masks shall be tested:3 asreceived, 3 after temperatureconditioning in accordance with 8.3.2and 3 after the test for simulatedwearing in accordance with 8.3.1

P

8.9.1.2 Valved particle filtering half masks N

8.9.2 Exhalation resistance PSeal the particle filtering half maskon the Sheffield dummy head.Measure the exhalation resistance atthe opening for mouth of the dummyhead using the adapter and abreathing machine adjusted to 25cycles/min and 2.0 l/stroke or acontinous flow 160 l/min.

P

8.9.3 Inhalation resistance PTest the inhalation resistance at 30l/min and 95 l/min continuous flow. P

8.10 Clogging P

8.10.1 Principle P


Page: 19 of 23

EN149: 2001 + A1: 2009


The test aerosol shall be dolomite. Atotal of 3 particle filtering half masksshall be tested: 1 as received and 2after temperature conditioning inaccordance with 8.3.2. The testconsists of subjecting the particlefiltering half maskto a sinusoidal breathing simulation

P

8.10.2 Test equipment PA scheme of a typical apparatus isgiven. The working area of the testchamber has a suggested squaresection of 650 mm. The breathingmachine has a displacement of 2,0l/stroke. The exhaled air shall pass ahumidifier in the exhaled air circuit,such that the exhaled airtemperature, measured at theposition of the sample particlefiltering half mask is (37±2) ℃ and95 % R.H. minimum.

P

8.10.3 Test conditions P---Dust: DRB 4/15 dolomite The sizedistribution of dolomite dust is given. P

8.10.4 Test procedure PConvey dust from the distributor tothe dust chamber where it isdispersed into the air stream of 60m3/h.Fit the sample particle filteringhalf mask in a leaktight manner to adummy head or a suitable filterholder located in the dust chamber.

P

8.10.5 Assessment of clogging PFollowing the exposure, measure thebreathing resistance of the particlefiltering half mask using clean air.Then measure the filter penetrationin accordance with 8.11.

P

8.11 Filter penetration P


Page: 20 of 23

EN149: 2001 + A1: 2009


The device shall be mounted in aleaktight manner on a suitable formerand subjected to the filter penetrationtest, ensuring that components of thedevice that could affect filterpenetration values such as valvesand harness attachment points areexposed to the challenge aerosol.Testing shall be done in accordancewith EN 143.

P

9 Marking P

9.1 Packaging PThe following information shall beclearly and durably marked on thesmallest commercially availablepackaging or legible through it if thepackaging is transparent.

P

9.1.1The name, trademark or othermeans of identification of themanufacturer or supplier.

P

9.1.2 Type-identifying marking. P

9.1.3 Classification: FFP1, FFP2, FFP3. FFP2 P

9.1.4 The number and year of publicationof this European Standard. P

9.1.5

At least the year of end of shelf life.The end of shelf life may be informedby a pictogram, where yyyy/mmindicates the year and month.

P

9.1.6

The sentence‘see informationsupplied by the manufacturer’, atleast in the official language(s) of thecountry of destination, or by usingthe pictogram.

P

9.1.7The manufacturer’s recommendedconditions of storage or equivalentpictogram.

P

9.1.8

The packaging of those particlefiltering half masks passing thedolomite clogging test shall beadditionally marked with the letter"D".

P

9.2 Particle filtering half mask P


Page: 21 of 23

EN149: 2001 + A1: 2009


Particle filtering half masks

complying with this European

Standard shall be clearly and durably

marked with the following:

P

9.2.1The name, trademark or othermeans of identification of themanufacturer or supplier.

P

9.2.2 Type-identifying marking. P

9.2.3 The number and year of publicationof this European Standard. P

9.2.4 The symbols FFP1, FFP2 or FFP3according to class.

FFP2 P

9.2.5

If appropriate the letter D (dolomite)in accordance with cloggingperformance. This letter shall followthe class designation

P

9.2.6

Sub-assemblies and componentswith considerable bearing on safetyshall be marked so thatthey can be identified.

N

10 Information to be supplied by the manufacturer P

10.1

Information supplied by themanufacturer shall accompany everysmallest commercial availablepackage.

P

10.2

Information supplied by themanufacturer shall be at least in theofficial language(s) of the country ofdestination.

P

10.3

The information supplied by themanufacturer shall contain allinformation necessary for trainedand qualified persons on

P

---application/limitations; P

---the meaning of any colour coding; P

---checks prior to use; P---donning, fitting; P---use; P


Page: 22 of 23

EN149: 2001 + A1: 2009


---maintenance (e.g. cleaning,disinfecting), if applicable; P

---storage; P---the meaning of anysymbols/pictograms used of theequipment.

P

10.4

The information shall be clear andcomprehensible. If helpful,illustrations, part numbers, markingshall be added.

P

10.5

Warning shall be given againstproblems likely to be encountered,for example:

P

---fit of particle filtering half mask(check prior to use); P

---it is unlikely that the requirementsfor leakage will be achieved if facialhair passes under the faceseal;

P

---air quality (contaminants, oxygendeficiency); P

---use of equipment in explosiveatmosphere. P

10.6

The information shall providerecommendations as to when theparticle filtering half mask shall bediscarded.

P

iec test report form template tecnica ce- 50 kn95_1.pdf · report no.:hx2003014394 page: 9 of 23...

Documents