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
Spiromètre permettant la mesure du débit de pointe expiratoire
La présente Norme spécifie les exigences relatives aux spiromètres permettant de mesurer les débits de pointe expiratoire (PEFM), destinés à l'évaluation de la fonction pulmonaire chez les êtres 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
- Status
- Withdrawn
- Publication Date
- 03-Jun-2003
- Withdrawal Date
- 14-Jul-2007
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Jul-2007
- Completion Date
- 15-Jul-2007
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 13826:2003 is a standard published by the European Committee for Standardization (CEN). Its full title is "Peak expiratory flow meters". This standard covers: 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.
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.
EN 13826:2003 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13826:2003 has the following relationships with other standards: It is inter standard links to EN ISO 23747:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13826:2003 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 13826:2003 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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
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
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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