SIST EN ISO 23747:2015

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



SIST EN ISO 23747:2015



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



EN ISO 23747:2015 (E) 2 Contents Page European foreword .3 Annex ZA (informative)
Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 23747:2015



EN ISO 23747:2015 (E) 3 European foreword This document (EN ISO 23747:2015) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. 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 23747:2009. 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 EU Directive(s). For relationship with EU Directive(s), 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, 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 the United Kingdom. Endorsement notice The text of ISO 23747:2015 has been approved by CEN as EN ISO 23747:2015 without any modification. SIST EN ISO 23747:2015



EN ISO 23747:2015 (E) 4 Annex ZA (informative)
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
SIST EN ISO 23747:2015



EN ISO 23747:2015 (E) 5 Corresponding essential requirement of Directive 93/42/EEC Clause/subclause of this Document Qualifying remarks/notes 9.3 — This relevant ER is not covered by this standard. 10.1 5.1 b), 5.4 b), 5.4 c), 5.4 d), 6, 7, 8, 9
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



EN ISO 23747:2015 (E) 6 Corresponding essential requirement of Directive 93/42/EEC Clause/subclause of this Document Qualifying remarks/notes 13.6 a) [13.3 c] — This relevant ER is not covered by this standard. 13.6 a) [13.3 f] — This relevant ER is not covered by this standard. 13.6 a) [13.3 i] 5.3 e)
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



EN ISO 23747:2015 (E) 7 Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this Document (according to article 3 of amended Directive 93/42/EEC) EHSR of 2006/42/EC Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes 1.1.4 – This relevant EHSR is not covered by this standard. 1.2.2 – This relevant EHSR is not covered by this standard. 1.5.4 – This relevant EHSR is not covered by this standard. 3.6.2 – This relevant EHSR is not covered by this standard.
SIST EN ISO 23747:2015



SIST EN ISO 23747:2015



© ISO 2015Anaesthetic and respiratory equipment — Peak expiratory
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. +41 22 749 01 11Fax +41 22 749 09 47copyright 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 .67.1 Error of measurement .6 yä t Linearity .6 yä u Resistance to
Ðlow .6 yä v Frequency response .6 z Dismantling and reassembly .6 { Effects of mechanical ageing .6 s r Effects of dropping a handæheld RGO .7 s s Cleaningá sterilizationá and disinfection .711.1 Reusable RGHO and parts .711.2
RGHO and parts delivered sterile.7 s t Compatibility with substances .7 s u Biocompatibility .7Annex A (informative) Rationale for tests and examples of test apparatus .8Annex B (normative) Determination of errorá repeatabilityá and resistance to RGO output .11Annex C (normative) Determination of frequency response .14Annex D (normative) Test methods for determination of the effectsof dismantlingá ageing and dropping .16Annex E (informative) Environmental aspects .18Annex F (informative) Reference to the Essential Principles .20Annex G (informative) .24Bibliography .25© ISO 2015 – All rights reserved iiiContents PageSIST EN ISO 23747:2015



ISO 23747:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards through ISO technical committeesä Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be notedä This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rightsä ISO shall not be held responsible for identifying any or all such patent rightsä Details of any the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO speci Ðic terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword æ Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment.ISO 23747:2007), which has been technically revisedä iv © ISO 2015 – All rights reservedSIST EN ISO 23747:2015



ISO 23747:2015(E)IntroductionThe development of a standard for RGCM GRTCT HNTCG (RGH) measurement is considered important for clinicians to use in diagnosing and monitoring lung and airway conditions by ensuring that all OGFECN FGEGU for such purposes meet minimum levels for safety and performanceä An agreed standard means that a RGCM GRTCT HN OGGT (RGHO) can be tested to meet the same requirements with the latest accepted methodsä Clinicians and patients can then be con Ðident that a RGHO is
Ðit for the purposes for which it is intendedäThe American Thoracic Society has been foremost in proposing initial standards for testing a RGHO (see Reference [15RGH, which are deemed suitable for checking that a RGHO can correctly measure RGH.The work of Miller et al. (see Reference [18RGHO inaccuracy and they have subsequently de Ðined the population characteristics of the RGH21]) and demonstrated limitations of pump systems for testing a RGHO (see Reference [20]). The European Respiratory Society has published a comprehensive statement on RGH (see Reference [21]).This International Standard is based on the best currently available evidence concerning the methods and waveforms suited for testing a RGHO (see Reference [17]).Throughout this International Standard, text for which a rationale is provided in Annex A, is indicated In this International Standardá the following print types are usedã Requirements and de Ðinitionsã roman typeä— Test speci Ôicationsã italic typeä— Informative material appearing outside of tables, such as notes, examples and references: in smaller typeä Normative text of tables is also in a smaller typeä TGTOU FGHPGF P JU RCTEWNCT UCPFCTF T CU PGFã UOCNN ECRCNU RGä © ISO 2015 – All rights reserved vSIST EN ISO 23747:2015



SIST EN ISO 23747:2015



Anaesthetic and respiratory equipment — Peak expiratory
Ðlow meters for the assessment of pulmonary function in spontaneously breathing humans1 ScopeThis International Standard speci Ðies requirements for a RGCM GRTCT HN OGGT (RGHO) intended for the assessment of pulmonary function in spontaneously breathing humansäThis International Standard covers all OGFECN FGEGU that measure RGCM GRTCT HNTCG in spontaneously breathing humans either as part of an integrated lung function OGFECN FGEG or as a stand-alone OGFECN FGEG.Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycleä Environmental aspects are addressed in Annex E.NOTE Additional aspects of environmental impact are addressed in ISO 14971. t Normative referencesThe following documentsá in whole or in partá are normatively referenced in this document and are indispensable for its applicationä For dated referencesá only the edition cited appliesä For undated ISO 10993-1:2009, Biological evaluation of medical devices Part
wã Evaluation and testing within a risk management processISO 14937:2009, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesISO 15223-1:2012, Medical devices Symbols to be used with medical device labelsá labelling and information to be supplied
wã General requirementsIEC 60601-1:2005+A1:2012, Medical electrical equipment Part
wã General requirements for basic safety and essential performance u Terms and de ÐinitionsFor the purposes of this documentá the following terms and de Ðinitions applyäNOTE An alphabetized index of de Ðined terms is found in Annex G.3.1DR 3.2FGNN OGFtime for which the expiratory
Ðlowrate is in excess of
{ r
¨ of the achieved RGHINTERNATIONAL STANDARD ISO 23747:2015(E)© ISO 2015 – All rights reserved 1SIST EN ISO 23747:2015



ISO 23747:2015(E)3.3OCPCETGTnatural or legal person with responsibility for the designá manufactureá packagingá or labelling of a OGFECN FGEGá assembling a systemá or adapting a OGFECN FGEG before it is placed on the market or put into serviceá regardless of whether these operations are carried out by that person or on that personïs behalf by a third partyNote
s to entryã Attention is drawn to the fact that the provisions of national or regional regulations can apply to the de Ðinition of manufactureräNote
t to entryã For a de Ðinition of labellingá see ISO 11] 3.4OGFECN FGEGany instrumentá apparatusá implementá machineá applianceá implantá in vitro reagent or calibrator, softwareá materialá or other similar or related articleá intended by the OCPWHCEWTGT (3.3) to be used, — diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosisá monitoringá treatmentá alleviation of or compensation for an injuryá investigationá replacementá modi Ðicationá or support of the anatomy or of a physiological processá— supporting or sustaining life,— control of conception,— disinfection of OGFECN FGEGU, providing information for medical purposes by means of in vitro examination of specimens derived from the human bodyáand which does not achieve its primary intended action in or on the human body by pharmacologicalá immunologicalá or metabolic meansá but which may be assisted in its function by such meansäNote
s to entryã TReference [15]. 3.5OQFGN QT RG TGGTGPEGcombination of
Ðiguresá lettersá or both used to identify a particular model of OGFECN FGEG (3.4
x r x r sæ sã t r r wá de Ðinition
uä x xá modi Ðiedã îequipment’ was replaced by îOGFECN FGEGï]3.6RGCM GRTCQT NQTCGRGmaximum
Ðlowrate measured at the mouth during an expiration delivered with maximal force starting immediately after achieving maximum lung in Ðlation3.7RGCM GRTCQT NQ OGGTRGOOGFECN FGEG (3.4) for measurement of 3.6) 2 © ISO 2015 – All rights reservedSIST EN ISO 23747:2015



ISO 23747:2015(E)3.8TGRQPDNG QTICPCQPentity accountable for the use and maintenance of a OGFECN FGEG (3.4)Note
s to entryã The accountable entity can beá for exampleá a hospitalá an individual clinicianá or a laypersonä In home use applications, the patient, operator, and TGURPUDNG TICPCP can be one and the same person.Note
t to entryã Education and training is included in òuseäó
x r x r sæ sã t r r wá de Ðinition
uä s r sá modi Ðiedã îan OG GSWROGP or an OG UUGOï was replaced by îa OGFECN FGEGï.]3.9TG OGTtime taken for
Ðlowrate to rise from
s r
¨ to
{ r 3.6) v General requirements vä s Safety for a RGO that utilizes electricityA RGHO that utilizes electrical power shall meet the requirements of IEC 60601-1:2005+A1:2012, in addition to the requirements in this International Standard.NOTE 1 IEC 60601–1 requires a RGHO to comply with IEC
xelectromagnetic compatibilityäNOTE 2 IEC 60601–1 requires a RGHO to comply with IEC
xNOTE 3 IEC 60601–1 requires a RGHO intended for use in the home healthcare environment to comply with IEC 60601–1-11.NOTE 4 IEC 60601–1 requires a RGHO intended for use in the emergency medical services environment to comply with IEC Check compliance by application of the tests of IEC 60601-1:2005+A1:2012ä vä t Mechanical basic safety for all RGORough surfacesá sharp cornersá and edgesá which can cause injury or damage shall be avoided or coveredä Particular attention shall be paid to
Ðlange or frame edges and the removal of burrsäCheck compliance by inspectionä w Identi Ðicationá marking and documents wä s Marking of the scale or displayThe scale or display of the RGHO shall be marked clearly and legibly as followsä The scale or display shall be marked in units of litres per second or litres per minuteäb) For a RGHO with a graduated scaleá the increment between adjacent graduations shall represent a difference in peak
Ðlowrate no greater than
s r l l l lor belowá and
t r l l l lRGHO with a digital displayá the incremental steps shall be no greater than
w
NOTE Litres per minute and litres per second are not exact equivalents because digital displays do not usually register to three decimal placesä © ISO 2015 – All rights reserved 3SIST EN ISO 23747:2015



ISO 23747:2015(E) The numbering and graduation lines on a scale or digital display shall be clearly legible with normal a distance of 0,5 m and at an ambient luminance in the range 100 lx to 1 500 lx].d) The numbering on a scale shall appear at intervals no greater than 50 l/min (0,83 l/s) up to 700 l/min (11,67 l/s) and 100 l/min (1,67 l/s) above 700 l/min (11,67 l/s). The numbering on a scale or digital display shall not exceed the measurement rangeäNOTE Clause 6 contains additional requirements.Check compliance by inspection and functional testingä wä t Marking of the RGO or packaging wä tä s Marking of the RGOThe RGHO an arrow showing the direction of
Ðlow for any userædetachable components that are
Ðlowædirectionæsensitive unless designed in such a way that prevents incorrect assemblyâb) the name or trade name and address of— the OCPWHCEWTGTá and— where the OCPWHCEWTGT does not have an address within the locale, an authorized representative within the locale, to which the TGURPUDNG TICPCP can referâ where appropriateá an identi Ðication reference to the batch codeá preceded by the word îLOTïá or serial numberá or symbol
wä sä w or
wä sä y from ISO
s w t t uæ sã t r s tâd) indications with regard to proper disposal, as appropriate.Check compliance by inspectionä wä tä t Marking of the RGO packagingThe
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