1、BS EN ISO23747:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic andrespiratory equipment Peak expiratoryflow meters forthe assessment ofpulmonary functionin spontaneouslybreathing humans (ISO23747:2007)This British Standardwas publish
2、ed under theauthority of the StandardsPolicy and StrategyCommittee on 30 April2009. BSI 2009ISBN 978 0 580 65200 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 23747:2009National forewordThis British Standard is the UK implementation of EN ISO 23747:2009.It is identical to ISO
3、 23747:2007. It supersedes BS EN ISO 23747:2007which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can be obtained onrequest to its secreta
4、ry.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 23747March 2009ICS 11.040
5、.10 Supersedes EN ISO 23747:2007 English VersionAnaesthetic and respiratory equipment - Peak expiratory flowmeters for the assessment of pulmonary function inspontaneously breathing humans (ISO 23747:2007)Matriel danesthsie et de ranimation respiratoire -Dbitmtres dbit de pointe expiratoire pour lva
6、luationde la fonction pulmonaire chez les tres humains respirantspontanment (ISO 23747:2007)Ansthesie- und Beatmungsgerte - Spirometer fr denexspiratorischen Spitzenfluss zur Bewertung derLungenfunktion bei spontan atmenden Menschen (ISO23747:2007)This European Standard was approved by CEN on 24 Feb
7、ruary 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 obta
8、ined 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 Manageme
9、nt 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, P
10、oland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any
11、 means reservedworldwide for CEN national Members.Ref. No. EN ISO 23747:2009: EBS EN ISO 23747:2009EN 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 Standardiza
12、tion (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 endorse
13、ment, 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 identif
14、ying 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,
15、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
16、, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 23747:2007 has been approved by CEN as
17、 a EN ISO 23747:2009 without any modification. BS EN ISO 23747:2009EN ISO 23747:2009 (E) 4 Annex ZA (informative) 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
18、 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
19、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. Tab
20、le 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
21、 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
22、.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 Essent
23、ial 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
24、, 13.3 d) And via IEC 60601-1, Subclauses 7.2, 7.4, 7.5, 7.6 BS EN ISO 23747:2009EN ISO 23747:2009 (E) 5 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 add
25、ressed 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
26、 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
27、 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 IE
28、C 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.
29、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 BS EN ISO 23747:2009EN ISO 23747:2009 (E) 6 5.4 d) 10.1, 13.6
30、 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 6
31、0601-1, 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
32、 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,a
33、nd 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
34、, 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 BS EN ISO 23
35、747:2009EN ISO 23747:2009 (E) 7 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.
36、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
37、 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. BS EN ISO 23747:2009ISO 23747:2007(E) ISO 2007 All rights reserved iiiCont
38、ents 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
39、.2 Marking of PEFM or packaging . 3 5.3 Instructions for use 3 5.4 Technical description. 4 6 PEFM measurement range. 4 7 Performance requirements 4 7.1 Error of measurement 4 7.2 Linearity . 4 7.3 Resistance to flow 5 7.4 Frequency response. 5 8 Dismantling and reassembly . 5 9 Effects of mechanica
40、l ageing 5 10 Effects of dropping a hand-held PEFM. 5 11 Cleaning, sterilization and disinfection 5 11.1 Re-usable PEFM and parts 5 11.2 PEFM and parts delivered sterile 6 12 Compatibility with substances 6 13 Biocompatibility 6 Annex A (informative) Rationale for tests and examples of test apparatu
41、s. 7 Annex B (normative) Determination of error, repeatability and resistance to PEFM output . 10 Annex C (normative) Determination of frequency response. 13 Annex D (normative) Test methods for determination of the effects of dismantling, ageing and dropping 15 Annex E (informative) Environmental a
42、spects 17 Annex F (informative) Reference to the essential principals. 19 Bibliography . 22 BS EN ISO 23747:2009ISO 23747:2007(E) iv ISO 2007 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies
43、). The work of preparing International Standards is normally carried out through ISO technical committees. 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 no
44、n-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Par
45、t 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting
46、 a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 23747 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipm
47、ent, Subcommittee SC 3, Lung ventilators and related equipment. BS EN ISO 23747:2009ISO 23747:2007(E) ISO 2007 All rights reserved vIntroduction The development of a standard for peak expiratory flowrate (PEF) measurement is considered important for the enhancement of the ability of clinicians to di
48、agnose and monitor lung conditions by ensuring that all devices for such purposes meet minimum levels for safety and performance. An agreed standard means that peak expiratory flow meters (PEFM) can be tested to meet the same requirements with the latest accepted methods. Clinicians and patients can
49、 then be confident that these PEFM are fit for the purposes for which they are intended. The American Thoracic Society has been foremost in proposing initial standards for testing PEFM 14. They have proposed 26 waveforms for testing PEF, which are deemed suitable for checking that these PEFMs can correctly measure PEF. The work of Miller et al. 16first showed the problem of PEFM inaccuracy and they have recently defined the population characteristics of the PEF profile 18and demonstrated limitations of pump systems f
