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1、BS EN ISO 23747:2009 ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) Licensed CopyChines
2、e University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2009. BSI 2009 ISBN 978 0 580 65200 4 Amendments/corrigenda issued since publication DateComments BS EN ISO 23747
3、:2009 National foreword This British Standard is the UK implementation of EN ISO 23747:2009. It is identical to ISO 23747:2007. It supersedes BS EN ISO 23747:2007 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tub
4、es and related equipment. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard
5、cannot confer immunity from legal obligations. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 23747 March 2009 ICS 11.040.10Supersedes EN ISO 23747:2007 English Version Anaesthetic and respiratory eq
6、uipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) Matriel danesthsie et de ranimation respiratoire - Dbitmtres dbit de pointe expiratoire pour lvaluation de la fonction pulmonaire chez les tres humains respirant spontanm
7、ent (ISO 23747:2007) Ansthesie- und Beatmungsgerte - Spirometer fr den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007) This European Standard was approved by CEN on 24 February 2009. CEN members are bound to comply with the CEN/CENELEC In
8、ternal 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 Management Centre or to any CEN m
9、ember. 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 Management Centre has the same status as the official versions. CEN me
10、mbers 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
11、, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref
12、. No. EN ISO 23747:2009: E Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 EN 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 In
13、ternational Organization for Standardization (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 public
14、ation of an identical text or by endorsement, 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 s
15、hall not be held responsible for identifying 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 Directive
16、s. For relationship with EC Directives, 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,
17、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 the United Kingdom. Endorsement notice The text of IS
18、O 23747:2007 has been approved by CEN as a EN ISO 23747:2009 without any modification. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 EN ISO 23747:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Es
19、sential 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 device
20、s. 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 standa
21、rd, 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
22、 (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
23、.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
24、.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
25、, 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 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747
26、:2009 EN 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 addressed in this European Standard 5.2.2 a) 13.3 b) And via IEC 60601-1, Subc
27、lause 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.
28、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.
29、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)
30、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, 9,1
31、1.2.2, 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 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 EN ISO 23747:2009 (E) 6
32、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,
33、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.
34、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 6
35、0601-1, 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
36、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 Subclaus
37、e 9.6 Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 EN 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
38、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 comm
39、ents 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 sc
40、ope of this International standard. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 ISO 23747:2007(E) ISO 2007 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definition
41、s. 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. 3 5.3 Instructions for use 3 5.4 Technical description. 4 6 PEFM me
42、asurement 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 mechanical ageing 5 10 Effects of dropping a hand-held PEFM. 5 11 Cleaning, sterilization and disinfection 5 11.
43、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 apparatus. 7 Annex B (normative) Determination of error, repeatability and resistance to PEFM output . 10 Annex
44、 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 aspects 17 Annex F (informative) Reference to the essential principals. 19 Bibliography. 22 Licensed Cop
45、yChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 ISO 23747:2007(E) iv ISO 2007 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work
46、 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 non-governmen
47、tal, 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, Part 2. The ma
48、in 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 a vote. At
49、tention 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 equipment, Subcommittee SC 3, Lung ventilators and related equipment. Licensed CopyChinese University of Hong Kong, 13/06/2009 08:06, Uncontrolled Copy, (c) BSI BS EN ISO 23747:2009 ISO 23747:2007(E) ISO 2007 All rights reserved v Introd