SIST EN 13328-1:2002

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performanceFiltres des sytemes respiratoires utilsés en anesthésie et soins respiratoires - Partie 1: Méthode d'essai avec une solution saline pour l'évaluation des performances de filtrationFilter für Atemsysteme zur Anwendung bei Anästhesie une Beatmung - Teil 1: Prüfverfahren mit Salzpartikeln zur Bewertung der Filterleistung11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SIST EN 13328-1:2002enTa slovenski standard je istoveten z:EN 13328-1:200101-maj-2002SIST EN 13328-1:2002SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13328-1December 2001ICS 11.040.10English versionBreathing system filters for anaesthetic and respiratory use -Part 1: Salt test method to assess filtration performanceThis European Standard was approved by CEN on 29 June 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13328-1:2001 E

Non-filtration aspects of BSFs are addressed in prEN 13328-2.2 Terms and definitionsFor the purposes of this European Standard, the following terms and definitionsapply:2.1breathing system filterdevice intended to reduce transmission of particulates including micro-organisms inbreathing systemsNOTE
Referred to in this European Standard as ‘BSF’; (plural ‘BSFs’).2.2challenge concentrationCconcentration of sodium chloride particles in the airstream as it enters the BSF2.3penetration concentrationPconcentration of sodium chloride particles in the airstream leaving the BSF2.4penetration valuePVconcentration of sodium chloride particles passing through the BSF as a percentageof the concentration in the challenge2.5filtration efficiency percent100 minus the penetration value

- temperature: (23 ± 2) °C;
- relative humidity: (60 ± 15) %;- pressure: (96 ± 10) kPa.3.3 Apparatus3.3.1 Flowmeter, with an error limit of ± 5 % of the actual value to be measured.3.3.2 Sodium chloride aerosol generator, capable of generating an aerosol at(25 ± 5) °C and relative humidity of (30 ± 10) % with a concentration from10 mg-3 to 20 mg-3 which has been neutralized to the Boltzmann equilibriumstate.NOTE
Suitable equipment is Model 8118A sodium chloride aerosol generator, TSI Inc., POBox 64394, St. Paul, MN 55164, USA.1)3.3.3 Scanning mobility particle sizer, or equivalent instrument.NOTE
Suitable equipment is Model 3936 scanning mobility particle sizer, TSI Inc., PO Box64394, St. Paul, MN 55164, USA.1)3.3.4 Suitable forward-light-scattering photometer, or equivalent instrument.NOTE
Suitable equipment is Model AFT 8130, TSI Inc., PO Box 64394, St. Paul, MN 55164,USA.1)
1) This information is given for the convenience of users of this standard and does not constitute anendorsement by CEN of the product named.

Rationales for various aspects of this method are given in annex C.3.6.1 Set the flow through the test apparatus (see Figure 1) to the appropriate valuefor the intended use of the BSF given in Table 1, using the flowmeter (3.3.1).3.6.2 Using the aerosol generator (3.3.2), generate a sodium chloride aerosol at(25 ± 5) °C and relative humidity of (30 ± 10) % with a concentration from 10 mg-3to 20 mg-3 which has been neutralized to the Boltzmann equilibrium state.3.6.3 Using the scanning mobility particle sizer (3.3.3), confirm that the sodiumchloride test aerosol has a particle size distribution with a count median diameter of(0,075 ± 0,020) µm and a geometric standard deviation not exceeding 1,86 at thespecified test conditions.NOTE 1
A particle size distribution with a count median diameter of 0,075 µm and ageometric standard deviation of 1,86 has a mass median aerodynamic diameter (MMAD) of0,26 µm. See annex B.NOTE 2
This is a calibration step and only needs to be performed as recommended by themanufacturer of the test equipment.3.6.4 Without a BSF attached, interconnect the two photometers (3.3.4) and measurethe challenge concentration at the upstream photometer. Check that the challengeconcentration at the downstream photometer is ± 2,5 % of this value each time theapparatus is switched on, when the airflow is changed and after the BSF sample size(3.5) has been tested.3.6.5 Fit a BSF in the unconditioned state to the test apparatus. Test the BSF usingthe flow direction stated by the manufacturer. If the flow direction is not stated,perform the test with the airstream entering the BSF at the machine port.3.6.6 Repeat 3.6.2.3.6.7
Measure the challenge concentration (C) and penetration concentration (P)whilst continuing the test until an aerosol mass of (0,2 ± 0,1) mg for adult BSFs or(0,1 ± 0,05) mg for paediatric BSFs has contacted the BSF.3.6.8 Repeat 3.6.5 to 3.6.7 using a BSF in the conditioned state (see 3.4).

Compressed air8
To vacuum2
Aerosol generator9
BSF under test3
Neutralizer10
Downstream photometer4
Mixing chamber11
Flowmeter5
Exhaust12 Flow control valve6
Switching valve7
Upstream photometer13
Position for scanning mobility particlesizer, when usedFigure 1 - Apparatus for testing BSF4 Calculation and expression of test resultsFor the BSFs tested, calculate the penetration value (PV) from the followingexpression:PV = P/C x 100whereP is the penetration concentration, determined in accordance with 3.6;C is the challenge concentration, determined in accordance with 3.6.Table 1 – Flow rates for testing BSFsBSF intended useFlow ratel-1paediatric15adult30

- temperature: (23 ± 2) °C;
- relative humidity: (60 ± 15) %;
- pressure: (96 ± 10) kPa.A.3 ApparatusA.3.1 Inspiratory limb humidity generator [see Figure A.1a)], to increase thetemperature and relative humidity of the inspired air if required (see A.4).A.3.2 Breathing system [see Figure A.1b)], consisting of an inspiratory limb, a Y-piece with a patient connection port, and an expiratory limb, having one-way valvesplaced at the ends of the breathing system limbs to ensure uni-directional flowthrough the breathing system.A.3.3 Humidity-generating patient model (see Figure A.1c), consisting of;a) an insulated chamber, the internal temperature of which is maintained at(37 ± 1) °C;b) a heated water bath, maintained at (37 ± 1) °C, through which air is bubbled inboth directions;c) a rigid reservoir containing a 2 l reservoir bag;d) a reciprocating piston/bellows pump.

1) oC and the relativehumidity to
90 % and place the BSF at position A. A.4.2.2 To simulate use with a hot water humidifier, set the mean temperature at theinlet to the Y-piece to (38
1) oC and the relative humidity to
90 % and place theBSF at position B.A.4.3 With the inspiratory limb humidity generator removed from the breathingsystemA.4.3.1 To simulate use in a non-rebreathing system, place the BSF at position A.A.4.3.2 To simulate use in the expiratory limb of a breathing system, place the BSFat position C.A.5 ProcedureA.5.1 Set up the apparatus and operate the humidity-generating patient model,ensuring that the water bath temperature has stabilized at (37
1) oC. For theconditioning requirements specified in A.4.2, operate the inspiratory limb humiditygenerator until the temperature and humidity measured at position 1 of Figure A.1have reached the specified values. Set the patient model parameters according tothe intended use of the BSF, as given in Table A.1.A.5.2 Fit the BSF in the breathing system at the position required to simulate itsintended use, as given in A.4 and Figure A.1.A.5.3 O
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