SIST EN ISO 23747:2009

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

This International Standard specifies requirements for peak expiratory flow meters (PEFMs) intended for the
assessment of pulmonary function in spontaneously breathing humans.
This International Standard covers all devices that measure peak expiratory flowrate in spontaneously
breathing humans either as part of an integrated lung function device or as a stand-alone device.
Planning and design of products applying to this International Standard should consider the environmental
impact from the product during its life cycle. Environmental aspects are addressed in Annex E.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.

Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)

Diese Internationale Norm legt Anforderungen für Spirometer für den exspiratorischen Spitzenfluss (PEFM)
fest, die zur Beurteilung der Lungenfunktion bei spontan atmenden Menschen bestimmt sind.
Diese Internationale Norm gilt für alle Geräte, die den exspiratorischen Spitzenfluss bei spontan atmenden
Menschen als Teil eines kombinierten Geräts zur Messung der Lungenfunktion oder als Einzelgerät messen.
Bei der Planung und Auslegung von Produkten, für die diese Internationale Norm gilt, sollten die
Umweltauswirkungen des Produkts während seines Lebenszyklus berücksichtigt werden. Umweltgesichtspunkte
werden in Anhang E behandelt.
ANMERKUNG Zusätzliche Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.

Matériel d'anesthésie et de réanimation respiratoire - Débitmètres à débit de pointe expiratoire pour l'évaluation de la fonction pulmonaire chez les êtres humains respirant spontanément (ISO 23747:2007)

L'ISO 23747:2007 spécifie les exigences relatives aux débitmètres permettant le mesurage du débit de pointe expiratoire (PEFM), destinés à l'évaluation de la fonction pulmonaire chez les êtres humains en respiration spontanée.
L'ISO 23747:2007 couvre tous les dispositifs mesurant le débit de pointe expiratoire en tant que partie d'un dispositif intégré de fonctionnement des poumons ou en tant que dispositif indépendant.
Il est préférable que la planification et la conception des produits mettant l'ISO 23747:2007 en application prennent en compte les effets du produit sur l'environnement pendant son cycle de vie. Les aspects environnementaux sont abordés dans l'Annexe E.

Anestezijska in dihalna oprema - Merilniki največjega pretoka zraka med izdihom za oceno funkcije pljuč pri spontano dihajočih ljudeh (ISO 23747:2007)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2009
• Withdrawal Date: 15-Sep-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 15-Sep-2015
• Due Date: 08-Oct-2015
• Completion Date: 16-Sep-2015
• 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: EN ISO 23747:2009 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

Relations

• Replaces: SIST EN ISO 23747:2008 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 23747:2008 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
• Effective Date: 01-Jul-2009
• Replaced By: SIST EN ISO 23747:2015 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
• Effective Date: 01-Oct-2015

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)Matériel d'anesthésie et de réanimation respiratoire - Débitmètres à débit de pointe expiratoire pour l'évaluation de la fonction pulmonaire chez les êtres humains respirant spontanément (ISO 23747:2007)Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 23747:2009SIST EN ISO 23747:2009en01-julij-2009SIST EN ISO 23747:2009SLOVENSKI
STANDARDSIST EN ISO 23747:20081DGRPHãþD



SIST EN ISO 23747:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 23747March 2009ICS 11.040.10Supersedes EN ISO 23747:2007
English VersionAnaesthetic and respiratory equipment - Peak expiratory flowmeters for the assessment of pulmonary function inspontaneously breathing humans (ISO 23747:2007)Matériel d'anesthésie et de réanimation respiratoire -Débitmètres à débit de pointe expiratoire pour l'évaluationde la fonction pulmonaire chez les êtres humains respirantspontanément (ISO 23747:2007)Anästhesie- und Beatmungsgeräte - Spirometer für denexspiratorischen Spitzenfluss zur Bewertung derLungenfunktion bei spontan atmenden Menschen (ISO23747:2007)This European Standard was approved by CEN on 24 February 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 23747:2009: ESIST EN ISO 23747:2009



EN ISO 23747:2009 (E) 2 Contents Page Foreword .3 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4
SIST EN ISO 23747:2009



EN ISO 23747:2009 (E) 3 Foreword The text of ISO 23747:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 23747:2009 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 by publication of an identical text or by endorsement, at the latest by September 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 23747:2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directives. For relationship with EC Directives, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 an
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