EN 13328-1:2001
(Main)Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance
This part of this European Standard establishes a short-term airborne sodium chloride particle challenge test method for assessing the filtration performance of breathing system filters (BSFs) intended for the filtration of respired gases in humans. The test method is intended for BSFs used with a clinical breathing system.
It is not intended for other types of filter e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, to protect test equipment or for physiological respiratory measurements.
NOTE Non-filtration aspects of BSFs are addressed in prEN 13328-2.
Filter für Atemsysteme zur Anwendung bei Anästhesie une Beatmung - Teil 1: Prüfverfahren mit Salzpartikeln zur Bewertung der Filterleistung
Dieser Teil dieser Europäischen Norm legt ein nur kurze Zeit in Anspruch nehmendes Prüfverfahren fest, bei dem die Beaufschlagung mit luftgetragenen Natriumchloridpartikeln erfolgt. Das Verfahren dient der Bewertung der Filterleistung von Atemsystemfiltern (ASF), die zur Filtration von Atemgasen des Menschen vorgesehen sind. Das Verfahren ist für ASF bestimmt, die im Zusammenhang mit einem klinischen Beatmungssystem angewendet werden.
Es ist nicht anwendbar auf andere Filtertypen, z. B. Filter zum Schutz von Vakuumquellen oder von Leitungen zur Probenahme von Gasen, zur Filtration komprimierter Gase, zum Schutz von Prüfeinrichtungen oder für physiologische Atmungsmessungen.
ANMERKUNG Aspekte von Atemsystemfiltern, die nicht die Filtration betreffen, sind in prEN 13328-2 enthalten.
Filtres des sytèmes respiratoires utilsés en anesthésie et soins respiratoires - Partie 1: Méthode d'essai avec une solution saline pour l'évaluation des performances de filtration
Cette partie de la présente Norme européenne spécifie un essai d'exposition à court terme à des particules de chlorure de sodium en suspension dans l'air pour l'évaluation des performances de filtration des filtres des systèmes respiratoires (« breathing system filter », BSF) prévus pour la filtration des gaz respirés par les êtres humains. La présente méthode d'essai est destinée aux BSF utilisés avec un système respiratoire clinique.
Elle ne s'applique pas aux autres types de filtration, par exemple, à ceux conçus pour protéger les sources de vides ou les tubes d'échantillonnage de gaz, pour filtrer les gaz comprimés, pour protéger le matériel d'essai ou les systèmes de mesure respiratoire physiologique.
NOTE Les propriétés autres que la filtration sont traitées dans le prEN 13328-2.
Sistem dihalnih filtrov za anestezijsko in dihalno uporabo – 1. del: Preskusna metoda s soljo za ocenitev učinkovitosti filtracije
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Standards Content (Sample)
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
EN 13328-1:2001 (E)2ForewordThis European Standard has been prepared by Technical Committee CEN/TC 215"Respiratory and anaesthetic equipment", the secretariat of which is held by BSI.This European Standard shall be given the status of a national standard, either bypublication of an identical text or by endorsement, at the latest by June 2002, andconflicting national standards shall be withdrawn at the latest by June 2002.This European Standard has been prepared under a mandate given to CEN by theEuropean Commission and the European Free Trade Association, and supportsessential requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integralpart of this standard.EN 13328 consists of the following parts under the general title Breathing systemfilters for anaesthetic and respiratory use :— Part 1 : Salt test method to assess filtration performance— Part 2 : Non-filtration aspectsEN 13328-1 gives a test method for the assessment of the filtration performance ofbreathing system filters (BSFs) for anaesthetic and respiratory use. The method isbased on the USA National Institute for Occupational Safety and Health (NIOSH)method for Respiratory Protective Devices (42 CFR Part 84) [1] and uses sodiumchloride particles.Annex A is normative and forms part of this European Standard. Annexes B, C andZA are for information only.According to the CEN/CENELEC Internal Regulations, the national standardsorganizations of the following countries are bound to implement this EuropeanStandard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany,Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.
EN 13328-1:2001 (E)3IntroductionThis European Standard gives a method of test for assessing the filtrationperformance of breathing system filters (BSFs).BSFs are used to reduce the number of particulates, including micro-organisms, ingases delivered to, and exhaled from, patients.BSFs are exposed to various levels of humidity during clinical use. Exposure of theBSF to humidified air to simulate clinical use forms part of this method (see AnnexA), as it is possible that such exposure can influence the filtration performance of theBSF.In the test, the BSF is challenged with sodium chloride particles of the particle sizerange that is considered to be the most penetrating i.e. 0,1 µm to 0,3 µm (seeAnnex B).Experience gained in testing filters for respiratory protective devices has shown thatby using a test aerosol of the most penetrating size range, the greatest penetrationthrough the filter will be shown compared to any size aerosol. Therefore it is notnecessary to subject the filter to a bio-aerosol as a condition of test.It is recognized that transmission of micro-organisms across a filter can occur due to“channelling” and “grow through”. There are at present no accepted methods toquantify this occurrence. This test method is for comparison purposes only and hasno proven clinical relevance. The results are specific to the test method and no riskfactor should be derived from it.
EN 13328-1:2001 (E)41 ScopeThis part of this European Standard establishes a short-term airborne sodiumchloride particle challenge test method for assessing the filtration performance ofbreathing system filters (BSFs) intended for the filtration of respired gases inhumans. The test method is intended for BSFs used with a clinical breathing system.It is not intended for other types of filter e.g. those designed to protect vacuumsources or gas sample lines, to filter compressed gases, to protect test equipment orfor physiological respiratory measurements.NOTE
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
EN 13328-1:2001 (E)53 Test method3.1 Principle3.1.1. The ability of a BSF to remove particles is measured by nebulizing a sodiumchloride solution into an airstream and passing the aerosol produced by the nebulizerthrough the BSF. Annex B gives a further explanation of the particle size terminology.3.1.2 The generation of aerosols from a nebulizer produces particles that arecharged electrostatically. The magnitude of the charge is reduced by mixing theairstream containing the particles with an ionized flow of air so that, when the twoflows are mixed, the particles are neutralized to the Boltzmann equilibrium state.3.1.3 The flows chosen for testing represent the typical flows likely to be encounteredduring the intended use of the BSF.3.1.4 The performance of the BSF is assessed by measuring the penetrationconcentration of sodium chloride particles in the airstream leaving the BSF andcomparing this with the challenge concentration in the airstream entering the BSF.BSFs are tested in the unused state as removed from their packaging and afterconditioning to simulate clinical use.3.2 Test conditionsThe ambient conditions during the tests shall be:
- 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.
EN 13328-1:2001 (E)63.4 Conditioning of BSFsCondition the BSF in accordance with annex A.3.5 Sample sizeThe BSF manufacturer shall document the rationale for the test BSF sample sizechosen in order to demonstrate the filtration efficiency of the BSF.3.6 ProcedureNOTE
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).
EN 13328-1:2001 (E)71235413611129710888Key1
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
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