SIST EN 13826:2003
(Main)Peak expiratory flow meters
Peak expiratory flow meters
This European Standard specifies requirements for peak expiratory flow meters (PEFM) intended for the assessment of pulmonary function in spontaneously breathing humans.
This European Standard covers all devices that measure peak expiratory flow either as part of an integrated lung function device or as a stand-alone device.
Spirometer für den exspiratorischen Spitzenfluss
Spirometre permettant la mesure du débit de pointe expiratoire
La présente Norme spécifie les exigences relatives aux spirometres permettant de mesurer les débits de pointe expiratoire (PEFM), destinés a l'évaluation de la fonction pulmonaire chez les etres humains en respiration spontanée.
La présente Norme européenne couvre tous les dispositifs permettant de mesurer le débit de pointe expiratoire soit en tant que partie d'un dispositif de fonctionnement des poumons intégré, soit en tant que dispositif indépendant.
Merilniki maksimalnega pretoka zraka med izdihom
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Peak expiratory flow metersMerilniki maksimalnega pretoka zraka med izdihomSpirometre permettant la mesure du débit de pointe expiratoireSpirometer für den exspiratorischen SpitzenflussTa slovenski standard je istoveten z:EN 13826:2003SIST EN 13826:2003en11.040.10ICS:SLOVENSKI
STANDARDSIST EN 13826:200301-september-2003
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13826June 2003ICS 11.040.10English versionPeak expiratory flow metersSpiromètre permettant la mesure du débit de pointeexpiratoireSpirometer für den exspiratorischen SpitzenflussThis European Standard was approved by CEN on 21 April 2003.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,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13826:2003 E
EN 13826:2003 (E)2ContentspageForeword.4Introduction.51Scope.62Normative references.63Terms and definitions.64General requirements.74.1Electrical safety.74.2Mechanical safety.75Identification, marking and documents.75.1Marking of the scale or display.75.2Marking of PEFM or packaging.85.3Accompanying documents.85.4Technical description.96PEFM measurement ranges.97Performance requirements.97.1Error of measurement.97.2Linearity.97.3Resistance to flow.97.4Frequency response.108Dismantling and reassembly.109Effects of mechanical ageing.1010Effects of dropping hand-held PEFM.10Annex A (normative)
Method of determining error, repeatability and resistance to flow of peakexpiratory flow meter output.11A.1Principle.11A.2Apparatus.11A.3Procedure.11A.4Calculations.12A.5Test report.13A.6Pass/ fail criteria.13Annex B (normative)
Method of determining frequency response.14B.1Principle.14B.2Apparatus.14B.3Procedure.14B.4Calculations for frequency response.14B.5Test report.14B.6Pass/ fail criteria.15Annex C (normative)
Test methods for determining the effects of dismantling, ageing anddropping.16C.1Principle.16C.2Apparatus.16C.3Procedures.16C.4Calculation of effects.17C.5 Test report.17
EN 13826:2003 (E)3Annex D (informative)
Rationale for tests and examples of test apparatus.18D.1Introduction.18D.2General.19D.3Apparatus.20Annex ZA (informative)
Clauses of this European Standard addressing Essential Requirements orother provisions of EU Directives.22Bibliography.24
EN 13826:2003 (E)4ForewordThis document (EN 13826:2003) has been prepared by Technical Committee CEN/TC 215 “Respiratory andanaesthetic equipment”, the secretariat of which is held by BSI.This European Standard shall be given the status of a national standard, either by publication of an identicaltext or by endorsement, at the latest by December 2003, and conflicting national standards shall be withdrawnat the latest by December 2003.This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.Annexes A, B and C are normative and form part of this European Standard.Annexes D and ZA are informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark,Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
EN 13826:2003 (E)5IntroductionThe development of a standard for peak expiratory flow (PEF) measurement is considered essential toenhance the ability of clinicians to diagnose and monitor lung conditions by ensuring that all devices for suchpurposes meet minimum levels for safety and performance. An agreed standard means that peak expiratoryflow meters (PEFM) can be tested to meet the same standards with the latest accepted methods. Cliniciansand patients can then be confident that these PEFM are fit for the purpose.The American Thoracic Society has been foremost in proposing initial standards for testing PEFM [1]. Theyhave proposed 26 waveforms for testing PEF that are deemed representative signals to check that thesePEFM can correctly measure PEF.The work of Miller et al [2] first showed the problem of PEFM inaccuracy and they have recently defined thepopulation characteristics of the PEF profile [3] and demonstrated the limitations of pump systems for testingPEFM [4]. The European Respiratory Society has published a comprehensive statement on PEF [5].EN 13826 is based on the best currently available evidence concerning the methods and signals suited for thepurpose of testing PEFM [2]. This standard is applicable to devices that are designed either to measure PEF,or to record many other indices of lung function in addition to PEF.
EN 13826:2003 (E)61 ScopeThis European Standard specifies requirements for peak expiratory flow meters (PEFM) intended for theassessment of pulmonary function in spontaneously breathing humans.This European Standard covers all devices that measure peak expiratory flow either as part of an integratedlung function device or as a stand-alone device.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications.These normative references are cited at the appropriate places in the text, and the publications are listedhereafter. For dated references, subsequent amendments to or revisions of any of these publications apply tothis European Standard only when incorporated in it by amendment or revision. For undated references thelatest edition of the publication referred to applies (including amendments).EN 60601-1:1990, Medical electrical equipment. Part 1: General requirements for safety (IEC 60601-1:1988).EN 980:1996, Graphical symbols for use in the labelling of medical devices.3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply:3.1measurement rangeset of values of measurands for which the error of a measuring instrument is intended to lie within specifiedlimits3.2peak expiratory flow meterdevice for measurement of peak expiratory flowNOTEThe abbreviation PEFM is used throughout the document.3.3peak expiratory flowmaximum flow measured at the mouth during an expiration delivered with maximal force starting immediatelyafter achieving maximum lung inflationNOTEThe abbreviation PEF is used throughout the document.3.4BTPSbody temperature (37 °C), at the measured pressure and saturated with water vapourNOTE:BTPS is the abbreviation for Body Temperature, Pressure and Saturated water vapour.
EN 13826:2003 (E)73.5dwell timetime for which flow is in excess of 90% of the achieved PEFNOTEThe abbreviation DT is used throughout this standard.3.6rise timetime taken for flow to rise from 10% to 90% of the achieved PEFNOTEThe abbreviation RT is used throughout this standard.4 General requirements4.1 Electrical safetyPEFM that are defined as Medical Electrical Equipment (see sub-clause 2.2.15 of EN 60601-1:1990) shall, inaddition to the requirements in this European Standard, meet the applicable requirements in EN 60601-1 andamendments 1 and 2.The environmental conditions given in clause 7.1 of this European Standard replace those given in sub-clause10.2.1 of EN 60601-1:19904.2 Mechanical safetyRough surfaces, sharp corners and edges, which can cause injury or damage shall be avoided or covered. Inparticular, attention shall be paid to flange or frame edges and the removal of burrs.Compliance is checked by inspection.5 Identification, marking and documents5.1 Marking of the scale or displayThe scale or display of the PEFM shall be clearly and legibly marked with the following:a) The scale or display shall be marked in units of litres per second or litres per minute;b) for PEFM with a graduated scale the increment between any two adjacent graduation lines shall representa difference in peak flow no greater than 10 l/min (0,15 l/s) at flows of 700 l/min (11 l/s) or below,and 20 l/min (0,3 l/s) at flows above 700 l/min (11l/s). For PEFM with a digital display the incremental stepshall be no greater than 5 l/min or 0,02 l/s.NOTE5 l/min and 0,02 l/s are not exact equivalents because digital displays do not usually register to three decimalplaces.c) the numbering and graduation lines on a scale or digital display shall be clearly legible with normal vision.(i.e. a visual acuity of 1, corrected if necessary, at a distance of 0,5 m and at an ambient illuminance inthe range 100 Lx to 1500 Lx);d) the numbering on a scale shall appear at intervals no greater than 50 l/min (1,0l/s) up to 700 l/min(11,0 l/s) and 100 l/min (1,7 l/s) thereafter;e) the numbering on a scale or digital display shall not exceed the measurement range. (see clause 6).
EN 13826:2003 (E)85.2 Marking of PEFM or packaging5.2.1 Marking of the PEFMThe PEFM and/or its components shall be clearly and legibly marked with the following:a) an arrow showing the direction of flow for any user detachable components that are flow directionsensitive unless designed in such a way that prevents incorrect assembly;b) the name or trademark and address of the manufacturer;c) where appropriate, either the serial number or batch code preceded by the symbol for “BATCHCODE”(see symbol 4.3 of EN 980:1996).5.2.2 Marking of the packagingThe following shall be marked on the packaging:a) details to enable the user to identify the PEFM and the contents of the packaging;b) if appropriate, the symbol for “STERILE” (see symbols 4.6, 4.7 and 4.10 in EN 980:1996);c) if appropriate, the symbol for “USE BY” (see symbol 4.2 in EN 980:1996);d) if appropriate, an indication that the PEFM is for single patient use;e) any special storage and/or handling instructions;f) the intended purpose of the PEFM.5.3 Accompanying documentsThe accompanying documents shall include the following:a) the intended purpose of the PEFM including any restrictions for its use;b) a statement, if applicable, that the performance of the PEFM can be affected by the patient spitting orcoughing into the PEFM during expiration or by extremes of temperature, humidity and altitude;c) if the PEFM is intended to be dismantled by the user, the correct method of reassembly;d) details of what the user should do if unusual readings are obtained;e) recommended storage conditions;f) methods of cleaning, disinfection and sterilization, if appropriate;g) the highest resistance to flow within the measurement range of the PEFM and the flow at which thisoccurs;h) details of the nature and frequency of any maintenance and/or calibration needed to ensure that thePEFM operates properly and safely.
EN 13826:2003 (E)95.4 Technical descriptionThe technical description shall include the following:a) specification of the signal input/output part, if applicable;b) error of the measured value (see 7.1);c) a statement to the effect that the values displayed by the instrument are expressed as BTPS values;d) any correction factors to be applied for changes in ambient conditions.6 PEFM measurement rangesThe range shall be from no greater than 60 l/min (1,0 l/s) to not less than 800 l/min (13,3 l/s) and expressed atBTPS conditions.7 Performance requirements7.1 Error of measurementWhen tested in accordance with annex A, the maximum permissible error for flow in the measurement rangeshall be:± 10 l/min (± 0,15 l/s) or 10 % of the reading whichever is the greater. This applies under the followingenvironmental conditions: ambient temperature range from 10 °C to 35 °C; relative humidity range from 30 % RH to 75 % RH; altitude range from 0 m to 1 400 m (atmospheric pressure range from 1060 hPa to 850 hPa.NOTEThe maximum permissible error values do not take into account the error limits of the test apparatus specifiedin annex A.7.2 LinearityWhen tested in accordance with annex A, the difference between the mean error at any two consecutive testflows (see annex A) shall not exceed 5 % of the larger of the two test flows.NOTEThe linearity tolerances do not take into account the error limits of the test apparatus specified in annex AWhen tested in accordance with annex A and under ambient conditions, the span of the PEFM readings atany set peak flow in the measurement range shall not vary by more than 10 l/min (0,15 l/s) or 5 % of the meanof the readings, whichever is the greater.NOTEThe repeatability tolerances do not take into account the tolerances of the test apparatus specified in annex A.7.3 Resistance to flowWhen tested in accordance with annex A the resistance to flow across the measurement range of the PEFMshall not exceed 0,35 kPa/l/s (0,006 kPa/l/min).
EN 13826:2003 (E)107.4 Frequency responseWhen tested in accordance with annex B the difference between the indicated PEF values of the PEFM forProfiles A and B (see A 2.2, B 2.2 and Figure B1) shall for identical reference PEF not exceed 15 l/min (0,25l/s) or 12% whichever is the greater.NOTE
The frequency response tolerances do not take into account the error limits of the test apparatus specified inannex B8 Dismantling and reassembly8.1If intended for dismantling by the user, the PEFM shall be designed or marked to indicate correctreassembly when all parts are mated.8.2When tested in accordance with annex C after dismantling and reassembly in accordance with themanufacturer’s instructions, the PEFM shall meet the requirements of clause 7 and its readings shall not havechanged by more than 10 % or 10 l/min (0,15 l/s), whichever is the greater.9 Effects of mechanical ageingIf the PEFM has moving parts as part of the flow sensing/indicating system then after being tested ina
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