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)

ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.
ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device.
Planning and design of products applying to this International Standard are to 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 23747:2015)

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 MEDIZINPRODUKTE, die den EXSPIRATORISCHEN SPITZENFLUSS bei spontan atmenden Menschen als Teil eines medizinischen Systems 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 23747:2015)

L'ISO 23747:2015 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 23747:2015 couvre tous les dispositifs médicaux mesurant le débit de pointe expiratoire chez les êtres humains en respiratoire spontanée en tant que partie d'un dispositif médical intégré de fonctionnement des poumons ou en tant que dispositif médical indépendant.

Anestezijska in dihalna oprema - Merilniki največjega pretoka zraka med izdihom za oceno funkcije pljuč pri spontano dihajočih ljudeh (ISO 23747:2015)

Ta mednarodni standard določa zahteve za merilnike največjega pretoka zraka (PEFM) med izdihom za oceno funkcije pljuč pri spontano dihajočih ljudeh.
Ta mednarodni standard se uporablja za vse medicinske pripomočke za merjenje največjega pretoka zraka med izdihom za oceno funkcije pljuč pri spontano dihajočih ljudeh kot del integriranega medicinskega pripomočka za pljučno funkcijo ali kot samostojni medicinski pripomoček.
Pri načrtovanju in oblikovanju izdelkov, za katere se uporablja ta mednarodni standard, je treba upoštevati vpliv izdelka na okolje v času njegove življenjske dobe. Okoljski vidiki so obravnavani v dodatku E.
OPOMBA: Dodatni vidiki vpliva na okolje so obravnavani v ISO 14971.

General Information

• Status: Published
• Publication Date: 18-Aug-2015
• Withdrawal Date: 28-Feb-2016
• 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: 6060 - Definitive text made available (DAV) - Publishing
• 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 23747:2015 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)

Relations

• Replaces: 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)
• 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 23747:2015)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 23747:2015)Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 23747:2015SIST EN ISO 23747:2015en01-oktober-2015SIST EN ISO 23747:2015SLOVENSKI
STANDARDSIST EN ISO 23747:20091DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 23747
August 2015 ICS 11.040.10 Supersedes EN ISO 23747:2009English Version
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015)
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 23747:2015)
Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2015) This European Standard was approved by CEN on 13 June 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23747:2015 ESIST EN ISO 23747:2015

Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 23747:2015

Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC By agreement between ISO and CEN, this CEN annex is included in the DIS and the FDIS but will not appear in the published ISO document. This Document 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 14 June 1993 on the approximation of the laws of the Member States concerning medical devices” (Medical Device Directive). Once this document 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 document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC Corresponding essential requirement of Directive 93/42/EEC Clause/subclause of this Document Qualifying remarks/notes 7.1 12, 13 The part of ER 7.1 relating to biophysical or modelling research is not addressed. 7.2 — This relevant ER is not covered by this standard. 7.3 11, 12
7.5 12 The parts of ER 7.5 relating to phthalates are not addressed. 7.6 — This relevant ER is not covered by this standard. 8.1 5.3 f), 11.1
8.3 — This relevant ER is not covered by this standard. 8.4 11.2
8.5 — This relevant ER is not covered by this standard. 8.6 — This relevant ER is not covered by this standard. 8.7 — This relevant ER is not covered by this standard. 9.1 5.2.1 a), 5.4 a)
9.2 4.1, 4.2, 8, 9, 10
10.2 5.1 b), 6
10.3 5.1 a)
12.6 4.1
12.7.1 — This relevant ER is not covered by this standard. 12.7.2 — This relevant ER is not covered by this standard. 12.7.3 — This relevant ER is not covered by this standard. 12.7.4 — This relevant ER is not covered by this standard. 12.7.5 — This relevant ER is not covered by this standard. 12.9 5.1 b), 5.1 c), 5.1 d), 5.1 e), 5.2.1 a)
13.1 5
13.2 5.2.1 c), 5.2.2 b), 5.2.2 c)
13.3 a) 5.2.1 b)
13.3 b) 5.2.2 a)
13.3 c) 5.2.2 b)
13.3 d) 5.2.1 c)
13.3 e) 5.2.2 c)
13.3 f) 5.2.2 d)
13.3 i) 5.2.2 e)
13.3 j) 5.2.2 f)
13.3 k) — This relevant ER is not covered by this standard. 13.3 l) — This relevant ER is not covered by this standard. 13.3 m) 5.2.2 b)
13.4 5.2.2 f), 5.3 a)
13.5 — This relevant ER is not covered by this standard. 13.6 a) [13.3 a] 5.3 b)
13.6 a) [13.3 b] — This relevant ER is not covered by this standard. SIST EN ISO 23747:2015

13.6 a) [13.3 j] — This relevant ER is not covered by this standard. 13.6 a) [13.3 k] — This relevant ER is not covered by this standard. 13.6 a) [13.3 l] — This relevant ER is not covered by this standard. 13.6 a) [13.3 m] — This relevant ER is not covered by this standard. 13.6 b) — This relevant ER is not covered by this standard. 13.6 c) — This relevant ER is not covered by this standard. 13.6 d) 5.3 b), 5.3 c), 5.3 d), 5.3 f), 5.3 h)
13.6 h) 5.3 f) The part of ER 13.6 h) relating to single use is not addressed. 13.6 i) — This relevant ER is not covered by this standard. 13.6 k) 5.3 d)
13.6 l) — This relevant ER is not covered by this standard. 13.6 n) 5.3 i)
13.6 p) 5.3 j)
13.6 q) 5.3 l)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this International Standard. For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery directive. SIST EN ISO 23747:2015

Ðlow meters for the assessment of pulmonary function in spontaneously breathing humansMatériel d’anesthésie et de réanimation respiratoire — Débitmètres à débit de pointe expiratoire pour l’évaluation de la fonction pulmonaire chez les êtres humains respirant spontanémentINTERNATIONAL STANDARDISO23747Second edition2015-08-01Reference numberISO 23747:2015(E)SIST EN ISO 23747:2015

ISO 23747:2015(E) ii © ISO 2015 – All rights reservedCOPYRIGHT PROTECTED DOCUMENT©
ISO 2015, Published in SwitzerlandAll rights reservedä Unless otherwise speci Ðiedá no part of this publication may be reproduced or utilized otherwise in any form or by any meansá electronic or mechanicalá including photocopyingá or posting on the internet or an intranetá without prior written permissionä Permission can be requested from either ISO at the address below or ISOïs member body in the country of the requester.ISO copyright of ÐiceCh. de Blandonnet 8 • CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. [phone]Fax [phone]copyright 7isoäorgwww.iso.orgSIST EN ISO 23747:2015

ISO 23747:2015(E) Foreword .ivIntroduction .v1 Scope .1 t Normative references .1 u Terms and de Ðinitions .1 v General requirements .3 vä s Safety for a RGHO that utilizes electricity .3 vä t Mechanical basic safety for all RGHOU .3 w Identi Ðicationá marking and documents .3 wä s Marking of the scale or display .35.2 Marking of the RGHO or packaging .45.2.1 Marking of the RGHO.45.2.2 Marking of the RGHO packaging .45.3 Instructions for use .55.4 Technical description .56
RGO measurement range .5 y Performance requirements .
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