EN ISO 26782:2009

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

ISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg.
ISO 26782:2009 applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.

Anästhesie- und Beatmungsgeräte - Spirometer zur Messung des zeitbezogenen forcierten Exspirationsvolumens beim Menschen (ISO 26782:2009)

Diese Internationale Norm legt Anforderungen für Spirometer zur Beurteilung der Lungenfunktion beim Menschen mit einem Körpergewicht über 10 kg fest.
Diese Internationale Norm gilt für ein Spirometer, das zeitbezogene forcierte Exspirationsvolumina entweder als Bestandteil eines integrierten Lungenfunktionsgerätes oder als eigenständiges Gerät, ungeachtet des angewendeten Messverfahrens, misst.
Geräte, die zur kontinuierlichen Überwachung von Patienten vorgesehen sind, liegen außerhalb des Anwendungsbereichs
dieser Internationalen Norm.

Matériel d'anesthésie et de réanimation respiratoire - Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains (ISO 26782:2009)

L'ISO 26782:2009 spécifie les exigences relatives à des spiromètres destinés à l'évaluation de la fonction pulmonaire chez des humains pesant plus de 10 kg.
L'ISO 26782:2009 s'applique à des spiromètres qui mesurent des volumes expiratoires forcés chronométrés, intégrés à un dispositif d'essai de la fonction pulmonaire ou sous forme de dispositif autonome, indépendamment de la méthode de détection utilisée.

Anestezijska in dihalna oprema - Merilniki pretoka zraka (spirometri) za merjenje pospešenega volumna izdiha pri ljudeh (ISO 26782:2009)

Ta mednarodni standard določa zahteve za SPIROMETRE, ki se uporabljajo za ocenjevanje pljučne funkcije pri ljudeh, ki tehtajo več kot 10 kg. Ta mednarodni standard velja za SPIROMETRE, ki merijo pospešeni volumen izdiha in so del vgrajene naprave za pljučno funkcijo ali pa samostojni pripomoček, ne glede na uporabljeno metodo merjenja. Pripomočki, ki se uporabljajo za neprekinjeno spremljanje BOLNIKOV, so izven območja uporabe tega mednarodnega standarda.

General Information

• Status: Published
• Publication Date: 14-Jul-2009
• Withdrawal Date: 20-Mar-2010
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Jul-2009
• Due Date: 07-Apr-2008
• Completion Date: 15-Jul-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

Relations

• Corrected By: EN ISO 26782:2009/AC:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - Technical Corrigendum 1 (ISO 26782:2009/Cor 1:2009)
• Effective Date: 24-Oct-2009

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anestezijska in dihalna oprema - Merilniki pretoka zraka (spirometri) za merjenje pospešenega volumna izdiha pri ljudeh (ISO 26782:2009)Anästhesie- und Beatmungsgeräte - Spirometer zur Messung des zeitbezogenen forcierten Exspirationsvolumens beim Menschen (ISO 26782:2009)Matériel d'anesthésie et de réanimation respiratoire - Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains (ISO 26782:2009)Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 26782:2009SIST EN ISO 26782:2009en01-november-2009SIST EN ISO 26782:2009SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 26782July 2009ICS 11.040.10 English VersionAnaesthetic and respiratory equipment - Spirometers intendedfor the measurement of time forced expired volumes in humans(ISO 26782:2009)Matériel d'anesthésie et de réanimation respiratoire -Spiromètres destinés au mesurage des volumesexpiratoires forcés chronométrés chez les humains (ISO26782:2009)Anästhesie- und Beatmungsgeräte - Spirometer zurMessung des zeitbezogenen forciertenExspirationsvolumens beim Menschen (ISO 26782:2009)This European Standard was approved by CEN on 17 June 2009.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 CEN 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 CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 26782:2009: ESIST EN ISO 26782:2009

Relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 26782:2009

Relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC This standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means to conforming to Essential Requirements of the New Approach Directive 93/42/EEC, Council Directive of 29 March 2007 on the approximation of the laws of the Member States concerning medical devices” (Medical Device Directive).
Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/NotesAll 1, 2, 3
4.1 12.6, 13.1, 13.2, 13.6 f) And via IEC 60601-1 4.2 9.2
5 13.1 And via IEC 60601-1 5.1 10.1, 10.3 And via IEC 60601-1 5.2 4, 10.2 And via IEC 60601-1 5.3 4 And via IEC 60601-1 5.4 13
5.4.1 a) 13.6 d)
5.4.1 b) 13.3 a)
5.4.1 c) 13.3 b), o)
5.4.1 d) 13.3 d)
5.4.1 e) 13.6 n)
5.4.1 f) 13.3 e)
5.4.2 a) 13.3 b)
5.4.2 b) 13.4
5.4.2 c) 13.2, 13.3 e)
5.4.2 d) 13.3 f)
5.4.2 e) 13.3 f)
5.4.2 f) 5, 13.3 i) And via IEC 60601-1 5.4.2 g) 13.3 j)
5.4.2 h) 13.3 k)
5.4.2 i) 8.7, 13.2, 13.3 m)
5.5.1 9.1 And via IEC 60601-1 SIST EN ISO 26782:2009

5.5.1 b) 13.4
5.5.1 c), d), e) 13.6 b)
5.5.1 f) 13.6 a)
5.5.1 h) 13.6 a)
5.5.1 i) 13.6 a), b), n)
5.5.1 j) 13.6 b), d)
5.5.1 k) 13.6 c)
5.5.1 l) 13.6 i)
5.5.1 m) 13.6 k)
5.5.1 n) 13.3 i)
5.5.1 o) 13.6 d)
5.5.1 p) 13.6 c)
5.5.1 q) 13.3 k), 13.6 n)
5.5.1 r) 13.6 q)
5.5.2 13.6 g), h)
6 10.1 And via IEC 60601-1 7 10.2 And via IEC 60601-1 7 10.3 And via IEC 60601-1 7.1 4, 10.1 And via IEC 60601-1 8 4 And via IEC 60601-1 8.2 4, 9.2 And via IEC 60601-1 9.1, 9.2 8.1, 8.5 And via IEC 60601-1 9.3 7.3, 8.4 And via IEC 60601-1 10 7.1 And via IEC 60601-1 10 7.2 And via IEC 60601-1 10 7.3 And via IEC 60601-1 Annex C 6 a)
- 6, 7.5, 7.6, 9.3, 11.3.1, 12.2, 12.5, 12.7.1, 12.7.2, 12.7.3, 12.7.4, 12.7.5 Via IEC 60601-1 NOTE
ERs 13.3 a) and 13.6 h) are not fully addressed.
WARNING — Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
Reference numberISO 26782:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO26782First edition2009-07-15Anaesthetic and respiratory equipment —Spirometers intended for the measurement of time forced expired volumes in humans Matériel d'anesthésie et de réanimation respiratoire — Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains
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ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2009 – All rights reserved
ISO 26782:2009(E) © ISO 2009 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 *Scope.1 2 Normative references.1 3 Terms and definitions.2 4 General requirements.4 4.1 Electrical safety.4 4.2 Mechanical safety.4 5 Identification, marking and documents.4 5.1 Marking of the scale or display.4 5.2 Legibility of markings.5 5.3 Durability of markings.5 5.4 Marking of the spirometer or its packaging.6 5.5 Instructions for use.6 5.6 Technical description.8 6 *Measurement range.8 7 Performance requirements.8 7.1 Accuracy.8 7.2 Recording time.9 7.3 Graphical display aspect ratios.9 7.4 Volume recording.9 7.5 *Start of forced exhalation.9 7.6 *End of forced exhalation.9 7.7 Linearity.9 7.8 Repeatability.9 7.9 Expiratory impedance.10 8 Constructional requirements.10 8.1 Effects of dropping components of a hand-held spirometer or accessory.10 8.2 Calibration.10 8.3 Dismantling and re-assembly.10 9 Cleaning, sterilization and disinfection.10 9.1 Re-usable spirometer and parts.10 9.2 Spirometer and parts requiring processing before use.11 9.3 Spirometer and parts delivered sterile.11 10 Biocompatibility.11 Annex A (informative)
Rationale.
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