DIN EN ISO 26782-2010 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782 2009 + Cor 1 2009) German.pdf

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1、February 2010 Translation by DIN-Sprachendienst.English price group 15No 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).I

2、CS 11.040.10; 11.040.55!$W“1615258www.din.deDDIN EN ISO 26782Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expiredvolumes in humans (ISO 26782:2009 + Cor. 1:2009)(includes Corrigendum AC:2009)English translation of DIN EN ISO 26782:2010-02Ansthesie und

3、 Beatmungsgerte Spirometer zur Messung des zeitbezogenen forcierten Exspirationsvolumens beimMenschen (ISO 26782:2009 + Cor. 1:2009)(enthlt Berichtigung AC:2009)Englische bersetzung von DIN EN ISO 26782:2010-02Matriel danesthsie et de ranimation respiratoire Spiromtres destins au mesurage des volume

4、s expiratoires forcs chronomtrs chezles humains (ISO 26782:2009 + Cor. 1:2009)(Corrigendum AC:2009 inclus)Traduction anglaise de DIN EN ISO 26782:2010-02SupersedesDIN EN ISO 26782:2009-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 3

5、5 pages03.10 DIN EN ISO 26782:2010-02 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and an

6、aesthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), W orking Committee NA 053-03-01 AA Ansthesie und Beatmung. This standard contain

7、s specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 13485 DIN EN ISO 13485 ISO 14937 DIN EN ISO 14937 I

8、SO 14971 DIN EN ISO 14971 ISO 23747 DIN EN ISO 23747 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) Amendments This standard differs from DIN EN ISO 26782:2009-10 as follows: a) Based on technical Corrigendum 1:2009, Figure A.1 “Example of time zero determination” has been modified as follows: In the key,

9、point 2 “t0= 0,75 s” has been replaced with “t0= 0,075 s”. National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN ISO 10993-1, Biological evaluation of medical devices Part

10、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 requirements for characterization of a sterilizing agent and the development, va

11、lidation and routine control of a sterilization process DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 23747, Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans P

12、revious editions DIN EN ISO 26782: 2009-10EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 26782 July 2009 +AC November 2009 ICS 11.040.10; 11.040.55 English version Anaesthetic and respiratory equipment Spirometers intended for the measurement of time forced expired volumes in humans (ISO 2

13、6782:2009 + Cor. 1:2009) Matriel danesthsie et de ranimation respiratoire Spiromtres destins au mesurage des volumes expiratoires forcs chronomtrs chez les humains (ISO 26782:2009 + Cor. 1:2009) Ansthesie- und Beatmungsgerte Spirometer zur Messung des zeitbezogenen forcierten Exspirations-volumens b

14、eim Menschen (ISO 26782:2009 + Cor. 1:2009)EN ISO 26782:2009 was approved by CEN on 2009-06-17 and Corrigendum AC:2009 on 2009-11-15. 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 st

15、andard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other la

16、nguage made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland

17、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMI

18、TEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 26782:2009 + AC:2009 EContents 2 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms

19、and definitions .6 4 General requirements .8 4.1 Electrical safety .8 4.2 Mechanical safety8 5 Identification, marking and documents 8 5.1 Marking of the scale or display8 5.2 Legibility of markings .9 5.3 Durability of markings.9 5.4 Marking of the spirometer or its packaging10 5.5 Instructions for

20、 use.10 5.6 Technical description12 6 Measurement range.12 7 Performance requirements.12 7.1 Accuracy 12 7.2 Recording time 13 7.3 Graphical display aspect ratios .13 7.4 Volume recording13 7.5 Start of forced exhalation .13 7.6 End of forced exhalation.13 7.7 Linearity13 7.8 Repeatability 13 7.9 Ex

21、piratory impedance.14 8 Constructional requirements .14 8.1 Effects of dropping components of a hand-held spirometer or accessory 14 8.2 Calibration14 8.3 Dismantling and re-assembly 14 9 Cleaning, sterilization and disinfection.14 9.1 Re-usable spirometer and parts 14 9.2 Spirometer and parts requi

22、ring processing before use15 9.3 Spirometer and parts delivered sterile15 10 Biocompatibility.15 Annex A (informative) Rationale16 Annex B (normative) Testing accuracy, linearity and impedance of spirometers.20 Annex C (normative) Defined test profiles.24 Annex D (informative) Environmental aspects

23、27 Annex E (informative) Reference to the essential principals .28 Bibliography30 Alphabetized index of defined terms used in this International Standard .31 Annex ZA (informative) Relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC.32 DIN EN ISO 26782:2010-02

24、 EN ISO 26782:2009 + AC:2009 (E) Foreword 3 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 which is held by B

25、SI. 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 possibility that some

26、 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 Association, and

27、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 implement this Eu

28、ropean 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, Switzerland and the Unit

29、ed Kingdom. Endorsement notice The text of ISO 26782:2009 has been approved by CEN as EN ISO 26782:2009 without any modification. any modification. DIN EN ISO 26782:2010-02 EN ISO 26782:2009 + AC:2009 (E) The text of ISO 26782:2009/Cor. 1:2009 has been approved by CEN as EN ISO 26782:2009/AC:2009 wi

30、thout to EN ISO 26782:2009/AC:2009 Introduction 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

31、. These spirometric assessments 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 evaluat

32、ing pulmonary disability, public 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 howeve

33、r no recognised international or 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 Interna

34、tional Standard addresses this 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 Standar

35、d are considered to provide a practical 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

36、Annex A. It is considered that 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. Howe

37、ver, this annex does not form part 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 chang

38、e, and test methods: italic type; 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 (*). 4 DIN EN ISO 26782:2010-02 EN ISO 26782:2009 + AC:2009 (E) 1 *Scope This International Standard specifies req

39、uirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg. This International Standard 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

40、 of the measuring method employed. Devices intended for continuously monitoring PATIENTS are outside the scope of this International Standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cite

41、d applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10933-11), Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 149372), Sterilization of health care products General requ

42、irements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for 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 requiremen

43、ts 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) 5 DIN EN ISO 26782:2010-02 EN ISO 26782:2009 + AC:2009 (E) 3 Terms and definit

44、ions For the purposes of this document the following terms and definitions apply. For convenience, the sources of all defined terms used in this International Standard are given in the Alphabetical Index. 3.1 accessory additional part for use with SPIROMETER in order to: achieve the INTENDED USE, ad

45、apt it to some special use, facilitate its use, enable its functions to be integrated with those of other equipment NOTE Adapted from IEC 60601-1:2005, definition 3.3. 3.2 accompanying document document accompanying a SPIROMETER or ACCESSORY and containing information for those accountable for the i

46、nstallation, use and maintenance of the SPIROMETER or ACCESSORY, the OPERATOR or the RESPONSIBLE ORGANIZATION, particularly regarding safety NOTE Adapted from ISO 14971:2007, definition 2.1. 3.3 body temperature and pressure saturated BTPS body temperature (37 C), at the ambient pressure and saturat

47、ed with water vapour 3.4 clearly legible capable of being read by a person with normal vision IEC 60601-1:2005, definition 3.15 3.5 expected service life maximum period of useful life as defined by the MANUFACTURER IEC 60601-1:2005, definition 3.28 3.6 forced expiratory volume after time t FEVtexpir

48、atory volume of a PATIENT under forced conditions at time t in seconds, measured from TIME ZERO 3.7 forced vital capacity FVC maximal volume of air exhaled with a continuous maximum forced expiratory effort from the point of maximal inspiration 3.8 hand-held term referring to equipment intended to b

49、e supported by the hand during NORMAL USE NOTE Adapted from IEC 60601-1:2005, definition 3.37. 6 DIN EN ISO 26782:2010-02 EN ISO 26782:2009 + AC:2009 (E) 3.9 intended use use of a product, process or service in accordance with the specifications, instructions and information provided by the MANUFACTURER NOTE INTENDED USE is not to be confused with NORMAL USE. While both include the concept of use as intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE