EN ISO 26782-2009 en Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans《麻醉和呼吸设备 测量人类计时用力呼气量的肺活量计》.pdf

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1、BS EN ISO26782:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic andrespiratory equipment Spirometersintended for themeasurement oftime forced expiredvolumes in humansIncorporating corrigendum November 2009National forewordThis British

2、 Standard is the UK implementation of EN ISO 26782:2009. It is identical to ISO 26782:2009, incorporating corrigendum November 2009.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations re

3、presented 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 cannot confer immunity from legal obligations.BS EN IS

4、O 26782:2009This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2009 BSI 2010Amendments/corrigenda issued since publicationDate Comments 30 April 2010 Implementation of ISO corrigendum November 2009; Figure A.1 amendedISBN 978 0 580 69

5、712 8EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 26782July 2009ICS 11.040.10English VersionAnaesthetic and respiratory equipment - Spirometers intendedfor the measurement of time forced expired volumes in humans(ISO 26782:2009)Matriel danesthsie et de ranimation respiratoire -Spiromtres de

6、stins au mesurage des volumesexpiratoires forcs chronomtrs chez les humains (ISO26782:2009)Ansthesie- und Beatmungsgerte - Spirometer zurMessung des zeitbezogenen forciertenExspirationsvolumens beim Menschen (ISO 26782:2009)This European Standard was approved by CEN on 17 June 2009.CEN members are b

7、ound 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 obtained on application to the C

8、EN 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 Management Centre has the same statu

9、s 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, Poland, Portugal,Romania, Slo

10、vakia, 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 means reservedworldwide for

11、 CEN national Members.Ref. No. EN ISO 26782:2009: E3 Foreword This document (EN ISO 26782:2009) 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

12、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 January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the pos

13、sibility 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade

14、 Association, and supports essential requirements of EC Directive. For relationship with EC Directive, 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

15、 implement this European Standard: 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, Switze

16、rland and the United Kingdom. Endorsement notice The text of ISO 26782:2009 has been approved by CEN as a EN ISO 26782:2009 without any modification. BS EN ISO 26782:2009EN ISO 26782:2009 (E)4 Annex ZA (informative) Relationship between this standard and the Essential Requirements of EU Directive 93

17、/42/EEC This standard 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 29 March 2007 on the approximation of the l

18、aws of the Member States concerning medical devices” (Medical Device Directive). 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 stan

19、dard given in Table ZA.1 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. Table ZA.1 Correspondence between this standard and Directive 93/42/EEC Clause(s)/sub-clause

20、(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/NotesAll 1, 2, 3 4.1 12.6, 13.1, 13.2, 13.6 f) And via IEC 60601-1 4.2 9.2 5 13.1 And via IEC 60601-1 5.1 10.1, 10.3 And via IEC 60601-1 5.2 4, 10.2 And via IEC 60601-1 5.3 4 And via IEC 6060

21、1-1 5.4 13 5.4.1 a) 13.6 d) 5.4.1 b) 13.3 a) 5.4.1 c) 13.3 b), o) 5.4.1 d) 13.3 d) 5.4.1 e) 13.6 n) 5.4.1 f) 13.3 e) 5.4.2 a) 13.3 b) 5.4.2 b) 13.4 5.4.2 c) 13.2, 13.3 e) 5.4.2 d) 13.3 f) 5.4.2 e) 13.3 f) 5.4.2 f) 5, 13.3 i) And via IEC 60601-1 5.4.2 g) 13.3 j) 5.4.2 h) 13.3 k) 5.4.2 i) 8.7, 13.2, 1

22、3.3 m) 5.5.1 9.1 And via IEC 60601-1 BS EN ISO 26782:2009EN ISO 26782:2009 (E)5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this International Standard Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes5.5.1 a) 13.6 a) 5.5.1 b) 13.4 5.5.1 c), d), e) 13.6 b) 5.5.1 f

23、) 13.6 a) 5.5.1 h) 13.6 a) 5.5.1 i) 13.6 a), b), n) 5.5.1 j) 13.6 b), d) 5.5.1 k) 13.6 c) 5.5.1 l) 13.6 i) 5.5.1 m) 13.6 k) 5.5.1 n) 13.3 i) 5.5.1 o) 13.6 d) 5.5.1 p) 13.6 c) 5.5.1 q) 13.3 k), 13.6 n) 5.5.1 r) 13.6 q) 5.5.2 13.6 g), h) 6 10.1 And via IEC 60601-1 7 10.2 And via IEC 60601-1 7 10.3 And

24、 via IEC 60601-1 7.1 4, 10.1 And via IEC 60601-1 8 4 And via IEC 60601-1 8.2 4, 9.2 And via IEC 60601-1 9.1, 9.2 8.1, 8.5 And via IEC 60601-1 9.3 7.3, 8.4 And via IEC 60601-1 10 7.1 And via IEC 60601-1 10 7.2 And via IEC 60601-1 10 7.3 And via IEC 60601-1 Annex C 6 a) - 6, 7.5, 7.6, 9.3, 11.3.1, 12.

25、2, 12.5, 12.7.1, 12.7.2, 12.7.3, 12.7.4, 12.7.5 Via IEC 60601-1 NOTE ERs 13.3 a) and 13.6 h) are not fully addressed. WARNING Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard. BS EN ISO 26782:2009EN ISO 26782:2009 (E) ISO 2009 All

26、 rights reserved iiiContents Page Foreword iv Introduction.v 1 *Scope.1 2 Normative references1 3 Terms and definitions .2 4 General requirements .4 4.1 Electrical safety .4 4.2 Mechanical safety4 5 Identification, marking and documents 4 5.1 Marking of the scale or display4 5.2 Legibility of markin

27、gs .5 5.3 Durability of markings.5 5.4 Marking of the spirometer or its packaging6 5.5 Instructions for use .6 5.6 Technical description8 6 *Measurement range .8 7 Performance requirements.8 7.1 Accuracy.8 7.2 Recording time 9 7.3 Graphical display aspect ratios .9 7.4 Volume recording 9 7.5 *Start

28、of forced exhalation9 7.6 *End of forced exhalation .9 7.7 Linearity9 7.8 Repeatability 9 7.9 Expiratory impedance.10 8 Constructional requirements .10 8.1 Effects of dropping components of a hand-held spirometer or accessory 10 8.2 Calibration10 8.3 Dismantling and re-assembly 10 9 Cleaning, steril

29、ization and disinfection.10 9.1 Re-usable spirometer and parts 10 9.2 Spirometer and parts requiring processing before use 11 9.3 Spirometer and parts delivered sterile11 10 Biocompatibility.11 Annex A (informative) Rationale12 Annex B (normative) Testing accuracy, linearity and impedance of spirome

30、ters.16 Annex C (normative) * Defined test profiles.20 Annex D (informative) Environmental aspects 23 Annex E (informative) Reference to the essential principals .24 Bibliography26 Alphabetized index of defined terms used in this International Standard .27 BS EN ISO 26782:2009EN ISO 26782:2009 (E)iv

31、 ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interest

32、ed 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. ISO collaborates closely with the International Electrotechnical Co

33、mmission (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 main task of technical committees is to prepare International Standards. Draft International Standards adopted by the techn

34、ical 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO s

35、hall not be held responsible for identifying any or all such patent rights. ISO 26782 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. BS EN ISO 26782:2009EN ISO 26782:2009 (E) ISO 2009 All rights reserv

36、ed vIntroduction A spirometer is a medical device that records physiological lung ventilation volumes within the range of the vital capacity. The timed volumes that a PATIENT is able to expel after a maximal inspiration give a reliable method of assessing lung function. These spirometric assessments

37、 are used, for example, to screen individuals at risk of lung disease, to give objective measures in the presence of lung disease, to evaluate symptoms and pre-operative risk and to record the effect of therapeutic intervention. A SPIROMETER can also be used in evaluating pulmonary disability, publi

38、c health and clinical trials. The American Thoracic Society (ATS) and the European Respiratory Society (ERS) have been instrumental in developing recommendations for the standardization of lung function testing, including guidelines for spirometry 6, 7. There is however no recognised international o

39、r national standard for SPIROMETERS with reliance for accuracy, repeatability, etc. based on objective test methodology and on meeting defined tolerances when tested with a carefully selected set of defined test profiles such as those published by the ATS. This International Standard addresses this

40、problem by developing a standard for a SPIROMETER to give the clinician the confidence that any SPIROMETER used meets agreed standards of accuracy, repeatability, electrical safety, etc. The minimum safety requirements specified in this particular International Standard are considered to provide a p

41、ractical degree of safety in the operation of SPIROMETERS. The requirements are followed by specifications for the relevant tests. A “rationale and guidance” section giving some explanatory notes, where appropriate, about the more important requirements is included in Annex A. It is considered that

42、knowledge of the reasons for these requirements will not only facilitate the proper application of this International Standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form p

43、art of the requirements of this International Standard. In this document, the following print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes and examples: smaller roman type; description of type of document change, and test methods: italic typ

44、e; TERMS DEFINED IN THIS DOCUMENT: SMALL CAPITALS. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). BS EN ISO 26782:2009EN ISO 26782:2009 (E)BS EN ISO 26782:2009EN ISO 26782:2009 (E)INTERNATIONAL STANDARD ISO 2009 All rights reserved 1Anaes

45、thetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans 1 *Scope This International Standard specifies requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg. This International Stan

46、dard applies to a SPIROMETER that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed. Devices intended for continuously monitoring PATIENTS are outside the scope of this International St

47、andard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10933-11), Bio

48、logical evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 149372), 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

49、 medical devices ISO 15223-1:2007, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 1) To be published. (Revision of ISO 10993-1:2003) 2) To be published. (Revision of ISO 14937:2000) BS EN ISO 26782:2009EN ISO 26782:2009 (E)2 ISO 2009 All rights reserved3 Terms and definitions For the purposes of this document the followin