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)

ISO 23747:2007 specifies requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans.
ISO 23747:2007 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.

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: 03-Mar-2009
• Withdrawal Date: 18-Aug-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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: 19-Aug-2015
• Completion Date: 19-Aug-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: 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)

Relations

• Replaces: EN ISO 23747:2007 - 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
• Replaced By: 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: 26-Aug-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

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

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. 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. 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. - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All 1, 2, 3 And via IEC 60601-1 4.1 12.6 And via IEC 60601-1, Clauses 4, 8 4.2 9.2 And via IEC 60601-1, Clauses 4, 5, 9, and Subclauses 8.9.1.5, 12.2, 15.2 5 5, 13.1 And via IEC 60601-1, Clauses 4, 7 and Subclauses 7.2.17, 7.9.3.1, 15.3.7,16.2 5.1 a) 10.3 And via IEC 60601-1, Subclause 7.4.3 5.1 b) 10.1, 10.2, 12.9 And via IEC 60601-1, Clause 4 and Subclauses 7.4, 7.5, 7.6, 7.8, 12.1, 12.2 5.1 c) 12.9 And via IEC 60601-1, Clause 4, and Subclauses 7.4, 7.5, 7.6, 7.8, 12.2 5.1 d) 12.9 And via IEC 60601-1, Clause 4, and Subclauses 7.4, 7.5, 7.6, 7.8, 12.2 5.1 e) 12.9 And via IEC 60601-1, Clause 4, and Subclauses 7.4, 7.5, 7.6, 7.8, 12.2 5.2.1 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 5.2.1 a) 9.1, 12.9 And via IEC 60601-1, Clauses 4, 14, 16, and Subclauses 7.4, 7.5, 7.6, 7.8, 8.2, 8.3, 8.5.2, 8.5.5, 8.6.6, 8.10.3, 8.10.4, 9,11.2.2, 11.4, 11.5, 12.2 5.2.1 b) 13.3 a) And via IEC 60601-1, Subclause 7.2.2 5.2.1 c) 13.2, 13.3 d) And via IEC 60601-1, Subclauses 7.2, 7.4, 7.5, 7.6 SIST EN ISO 23747:2009

5.2.1 d) 13.6 n)
5.2.2 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 5.2.2 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 5.2.2 a) 13.3 b) And via IEC 60601-1, Subclause 7.2.2 5.2.2 b) 8.3, 8.7, 13.2, 13.3 c) And via IEC 60601-1, Subclauses 7.2, 7.4, 7.5, 7.6, 11.6.7 5.2.2 c) 13.3 e)
5.2.2 d) 13.2, 13.3 f) And via IEC 60601-1, Subclauses 7.2.1, 7.4, 7.5, 7.6 5.2.2 e) 13.3 i) And via IEC 60601-1, Subclause 7.2.17 5.2.2 f) 13.4 And via IEC 60601-1, Subclauses 7.9.2.1, 16.2 5.3 7.5 (3rd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 5.3 13.6 a) And via IEC 60601-1, Subclauses 7.9.1, 7.9.2, 16.2 5.3 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard
13.6 (q) This relevant Essential Requirement is not addressed in this European Standard 5.3 c) 13.6 d) And via IEC 60601-1, Subclauses 7.9.2.6, 7.9.2.8, 7.9.2.9, 7.9.2.13, 7.9.2.16, 9.8.1, 16.2 5.3 d) 13.6 b), 13.6 k) And via IEC 60601-1, Subclauses 7.9.2.1, 7.9.2.2 ,7.9.2.9,16.2 5.3 e) 13.6 i)
5.3 f) 7.6, 8.1, 13.6 h) And via IEC 60601-1, Subclauses 7.9.2.6, 7.9.2.8, 7.9.2.9, 7.9.2.12, 7.9.2.14, 11.3, 11.6.1, 11.6.7, 11.6.8, 13.1.2, 13.2.6, 16.2 5.4 a) 9.1, 13.6 b) And via IEC 60601-1, Clauses 4, 14, 16, and Subclauses 7.9.2.1, 7.9.2.2 ,7.9.2.9, 8.2, 8.3, 8.5.2, 8.5.5, 8.6.6, 8.10.3, 8.10.4, 9,11.2.2, 11.4, 11.5, 16.2 5.4 b) 10.1, 13.6 p) And via IEC 60601-1, Clause 4 and Subclause 12.1 5.4 c) 10.1, 13.6 l) And via IEC 60601-1, Clause 4 and Subclause 12.1 SIST EN ISO 23747:2009

5.4 d) 10.1, 13.6 l) And via IEC 60601-1, Clause 4 and Subclause 12.1 6 10.1, 10.2 And via IEC 60601-1, Clause 4 and Subclauses 12.1, 12.2 - 6a)
This relevant Essential Requirement is not addressed in this European Standard 7 3, 10.1 And via IEC 60601-1, Clause 4 and Subclauses 11.1, 12.1 8 4, 9.2, 10.1 And via IEC 60601-1, Clauses 4, 5, 9, 15 and Subclauses 7.9, 8.9.1.5, 12.1, 12.2, 15.2 9 4, 9.2, 10.1 And via IEC 60601-1, Clauses 4, 5, 9, 15 and Subclauses 7.9, 8.9.1.5, 12.1, 12.2, 15.2 10 4, 9.2 And via IEC 60601-1, Clauses 4, 5, 9, 15 and Subclauses 7.9, 8.9.1.5, 12.2, 15.2 11.1 4, 7.3, 8.1, 8.5 And via IEC 60601-1, Clauses 4, 15 and Subclauses 7.9, 11.2, 11.4, 11.5, 11.6, 11.7, 16.2 11.2 8.4 And via IEC 60601-1, Subclause 11.6.7 12 4, 7.1, 7.3, 7.5 And via IEC 60601-1, Clauses 4, 9, 15, and Subclauses 7.9, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 13.1.2, 13.2.6, 15.2 13 7.1 And via IEC 60601-1, Clause 9,and Subclauses 11.2, 11.3, 11.4, 11.5, 11.6.8, 11.7, 15.2 12, 13 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard — 7.2 Via IEC 60601-1, Subclauses 11.6.6, 11.6.7, 11.7, 15.3.7, 16.2 — 9.3 Via IEC 60601-1, Clause 4, and Subclauses 8.11.6, 11.2, 11.3, 11.4, 11.5, 13.1.2, 15.4.3.5 — 11.3.1 Via IEC 60601-1, Clauses 4, 10, and Subclause 12.4.5.1 — 12.5 Via IEC 60601-1, Clauses 4, 17 — 12.7.1 Via IEC 60601-1, Clauses 4, 9, and Subclause 15.3 — 12.7.2 Via IEC 60601-1, Clause 4 and Subclause 9.6 — 12.7.3 Via IEC 60601-1, Clause 4 and Subclause 9.6 SIST EN ISO 23747:2009

— 12.7.4 Via IEC 60601-1, Clause 4, and Subclauses 8.10.3, 8.10.4, 8.11 — 12.7.5 Via IEC 60601-1, Clause 4, and Subclauses 8.11.4, 11.1, 15.4.1, 16.9.1, 16.9.2.1 — 12.8.2 Via IEC 60601-1, Clause 4, and Subclauses 7.8, 12.3, 12.4 — 13.3 m) Via IEC 60601-1, Subclauses 6.4, 7.2.17 — 13.5 Via IEC 60601-1, Subclauses 7.2.2, 7.2.4 — 13.6 c) Via IEC 60601-1, Subclauses 7.9.2.6, 7.9.2.8, 7.9.2.9, 7.9.2.14, 16.2 — 13.6 f) Via IEC 60601-1, Subclause 7.9.2.2 a The following comments relating to clauses and subclauses of IEC 60601-1:2005 describe the consequences of the general normative reference to IEC 60601-1:2005 made in the requirement 4.1 of the present standard.
Warning – Other requirements and other EU Directives may be applicable to the products falling within the scope of this International standard.
Reference numberISO 23747:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO23747First edition2007-07-15Anaesthetic and respiratory equipment —Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans 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
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ii © ISO 2007 – All rights reserved
ISO 23747:2007(E) © ISO 2007 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 General requirements.2 4.1 Safety for PEFMs that utilize electricity.2 4.2 Mechanical safety for all PEFMs.2 5 Identification, marking and documents.2 5.1 Marking of the scale or display.2 5.2 Marking of PEFM or packaging.
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