DIN 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.pdf

1、December 2015 English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!%Izr“2388779www.din.d

2、eDIN EN ISO 23747Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015);English version EN ISO 23747:2015,English translation of DIN EN ISO 23747:2015-12Ansthesie- und Beatmungsgerte Spirometer fr

3、den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2015);Englische Fassung EN ISO 23747:2015,Englische bersetzung von DIN EN ISO 23747:2015-12Matriel danesthsie et de ranimation respiratoire Dbitmtres dbit de pointe expiratoire pour lvaluation

4、 de la fonction pulmonaire chez les tres humains respirant spontanment (ISO 23747:2015);Version anglaise EN ISO 23747:2015,Traduction anglaise de DIN EN ISO 23747:2015-12SupersedesDIN EN ISO 23747:2009-07www.beuth.deDocument comprises 38 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the

5、German-language original shall be considered authoritative.12.15DIN EN ISO 23747:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 23747:2015) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Tech

6、nical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat; BSI, United Kingdom). The responsible German body involved in its preparation was DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-01

7、 AA Ansthesie und Beatmung. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 128-30 DIN ISO 128-30 ISO 128-34 DIN ISO 128-34 ISO 128-40 DIN ISO 128-40 ISO 128-44 DIN ISO 128-44 ISO 690 DIN ISO 690 ISO 10993-1 DIN EN ISO 10993-1 ISO 13485

8、 DIN EN ISO 13485 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 IEC 60027 (all parts) DIN EN 60027 (all parts) IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) Amendments This standard differs from DIN EN ISO 23747:2009-07 as follows: a) requirements for marking and ins

9、tructions for use have been revised; b) the drop test has been revised for clarity; c) Equation D.1 in Annex D for calculating the effects of dismantling and re-assembling, mechanic ageing or dropping has been corrected; d) the standard has been editorially revised. Previous editions DIN EN 13826: 2

10、003-09 DIN EN ISO 23747: 2007-10, 2009-07 DIN EN ISO 23747:2015-12 3 National Annex NA (informative) Bibliography DIN ISO 128-30, Technical drawings General principles of presentation Part 30: Basic conventions for views DIN ISO 128-34, Technical drawings General principles of presentation Part 34:

11、Views on mechanical engineering drawings DIN ISO 128-40, Technical drawings General principles of presentation Part 40: Basic conventions for cuts and sections DIN ISO 128-44, Technical drawings General principles of presentation Part 44: Sections on mechanical engineering drawings DIN ISO 690, Info

12、rmation and documentation Guidelines for bibliographic references and citations to information resources DIN EN 60027 (all parts), Letter symbols to be used in electrical technology DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential

13、performance DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14937, Sterilization of health care products General re

14、quirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with me

15、dical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 23747:2015-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23747 August 2015 ICS 11.040.10 Supersedes EN ISO 23747:2009English Version Anaesthetic and

16、respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2015) Matriel danesthsie et de ranimation respiratoire - Dbitmtres dbit de pointe expiratoire pour lvaluation de la fonction pulmonaire chez les tres humains resp

17、irant spontanment (ISO 23747:2015) Ansthesie- und Beatmungsgerte - Spirometer fr 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/

18、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 Cent

19、re 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

20、 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, Netherl

21、ands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All right

22、s of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 23747:2015 EIntroduction 1 Scope .2 Normative references 3 Terms and definitions .4 General requirements .4.1 Safety for a pefm that utilizes electricity 4.2 Mechanical basic safety for all pe

23、fms 5 Identification, marking and documents .5.1 Marking of the scale or display .5.2 Marking of the pefm or packaging .5.2.1 Marking of the pefm5.2.2 Marking of the pefm packaging 5.3 Instructions for use .5.4 Technical description 6 pefm measurement range .7 Performance requirements 7.1 Error of m

24、easurement .7.2 Linearity .7.3 Resistance to flow 7.4 Frequency response 8 Dismantling and reassembly 9 Effects of mechanical ageing .10 Effects of dropping a hand-held pefm 11 Cleaning, sterilization, and disinfection .11.1 Reusable pefm and parts .11.2 pefm and parts delivered sterile.12 Compatibi

25、lity with substances 13 Biocompatibility Annex A (informative) Rationale for tests and examples of test apparatus .Annex B (normative) Determination of error, repeatability, and resistance to pefm output 15Annex C (normative) Determination of frequency response .18Annex D (normative) Test methods fo

26、r determination of the effectsof dismantling, ageing and dropping .Annex E (informative) Environmental aspects .Annex F (informative) Reference to the Essential Principles 24Annex G (informative) Terminology Alphabetized index of defined terms .2Bibliography Contents PageEN ISO 23747:2015 (E) DIN EN

27、 ISO 23747:2015-12 2European foreword . 3 Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC 2933455577777888999101010101010101111111111111220228European foreword This document (EN ISO 23747:2015) has been prepared by Technical Committe

28、e 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 te

29、xt 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 respo

30、nsible 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

31、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, C

32、zech 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 King

33、dom. Endorsement notice The text of ISO 23747:2015 has been approved by CEN as EN ISO 23747:2015 without any modification. EN ISO 23747:2015 (E) DIN EN ISO 23747:2015-12 3 IntroductionThe development of a standard for peak expiratory flowrate (pef) measurement is considered important for clinicians

34、to use in diagnosing and monitoring lung and airway conditions by ensuring that all medical devices for such purposes meet minimum levels for safety and performance. An agreed standard means that a peak expiratory flow meter (pefm) can be tested to meet the same requirements with the latest accepted

35、 methods. Clinicians and patients can then be confident that a pefm is fit for the purposes for which it is intended.The American Thoracic Society has been foremost in proposing initial standards for testing a pefm (see Reference 15). They have proposed 26 waveforms suitable for testing pef, which a

36、re deemed suitable for checking that a pefm can correctly measure pef.The work of Miller et al. (see Reference 18) first showed the problem of pefm inaccuracy and they have subsequently defined the population characteristics of the pef profile (see Reference 21) and demonstrated limitations of pump

37、systems for testing a pefm (see Reference 20). The European Respiratory Society has published a comprehensive statement on pef (see Reference 21).This International Standard is based on the best currently available evidence concerning the methods and waveforms suited for testing a pefm (see Referenc

38、e 17).Throughout this International Standard, text for which a rationale is provided in Annex A, is indicated by an asterisk (*).In this International Standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appear

39、ing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. Terms defined in this particular standard or as noted: small capitals type.EN ISO 23747:2015 (E) DIN EN ISO 23747:2015-12 4 1 ScopeThis International Standard specifies

40、 requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.This International Standard covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lun

41、g 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 environmenta

42、l impact are addressed in ISO 14971.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the refer

43、enced document (including any amendments) applies.ISO 10993-1:2009, Biological evaluation of medical devices Part 1: 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 d

44、evelopment, validation and routine control of a sterilization process for medical devicesISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirementsIEC 60601-1:2005+A1:2012, Medical electrical equipment Part 1

45、: General requirements for basic safety and essential performance3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.NOTE An alphabetized index of defined terms is found in Annex G.3.1btpsbody temperature (37 C), at the measured pressure when saturated

46、 with water vapour3.2dwell timedttime for which the expiratory flowrate is in excess of 90 % of the achieved pefEN ISO 23747:2015 (E) DIN EN ISO 23747:2015-12 5 3.3manufacturernatural or legal person with responsibility for the design, manufacture, packaging, or labelling of a medical device, assemb

47、ling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that persons behalf by a third partyNote 1 to entry: Attention is drawn to the fact that the provisions of national or region

48、al regulations can apply to the definition of manufacturer.Note 2 to entry: For a definition of labelling, see ISO 13485:2003, definition 3.6. 11SOURCE: ISO 14971:2007, definition 2.83.4medical deviceany instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, intended by the manufacturer (3.3) to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or