DIN EN 1060-3-2010 Non-invasive sphygmomanometers - Part 3 Supplementary requirements for electro-mechanical blood pressure measuring systems German version EN 1060-3 1997+A2 2009《.pdf

1、March 2010 Translation by DIN-Sprachendienst.English price group 13No 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

2、11.040.55!$a.“1621127www.din.deDDIN EN 1060-3Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical bloodpressure measuring systems (includes Amendment A2:2009)English translation of DIN EN 1060-3:2010-03Nichtinvasive Blutdruckmessgerte Teil 3: Ergnzende Anforderung

3、en fr elektromechanische Blutdruckmesssysteme(enthlt nderung A2:2009)Englische bersetzung von DIN EN 1060-3:2010-03Tensiomtres non invasifs Partie 3: Exigences complmentaires concernant les systmes lectromcaniques demesure de la pression sanguine (Amendement A2:2009 inclus)Traduction anglaise de DIN

4、 EN 1060-3:2010-03SupersedesDIN EN 1060-3:2006-11See start of validitywww.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.2703.10 DIN EN 1060-3:2010-03 A comma is used as the decimal marker. Start of validity This standard takes effect

5、 on 1 March 2010. DIN EN 1060-3:2006-11 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany) and includes Amendment 1 and Amendment 2 to EN 1060-3:1997. The responsibl

6、e German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-02-14 AA Nichtinvasive Blutdruckmessgerte. This standard together with European Standard EN 1060-1:1995 contains specifications meet

7、ing the essential requirements set out in EU Directive 93/42/EEC on medical devices. Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC

8、of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of bioc

9、idal products (Official Journal L 247 as of 21 September 2007, p. 21). Amendments This standard differs from DIN EN 1060-3:2006-11 as follows: a) The normative references have been updated. b) In clause 3, a reference to definitions given in EN 60601-1:2006 has been included. c) In subclause 7.7.2 “

10、Digital indication”, the reference to EN 60601-1:1990 has been replaced with EN 60601-1:2006. d) In subclause 7.10 “Alarms”, the reference to EN 475 has been replaced with EN 60601-1-8. e) In subclause 9.2 “Instructions for use”, the introductory sentence now reads: “9.2 of EN 1060-1 shall apply wit

11、h the following addition:”. f) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC. Previous editions DIN EN 1060-3: 1997-09, 2006-11 2 E

12、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1060-3:1997+A2 November 2009 ICS 11.040.55 Supersedes EN 1060-3:1997English Version Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems Tensiomtres non invasifs - Partie 3: Exi

13、gences complmentaires concernant les systmes lectromcaniques de mesure de la pression sanguine Nichtinvasive Blutdruckmessgerte - Teil 3: Ergnzende Anforderungen fr elektromechanische Blutdruckmesssysteme This European Standard was approved by CEN on 27 January 1997 and includes Amendment 1 approved

14、 by CEN on 24 November 2005 and Amendment 2 approved by CEN on 17 October 2009. 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 standard without any alteration. Up-to-date lists and bi

15、bliographical references concerning such national standards may be obtained 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 translation under the responsibili

16、ty of a CEN member into its own language and notified to the CEN 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, France, Germany, Greece, Hungary, Iceland,

17、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 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marn

18、ix 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 1060-3:1997+A2:2009: EEN 1060-3:1997+A2:2009 (E) 2 Contents Page Foreword 31 Scope 42 Normative references 43 Definitions 44 Cuff 55 Display 66 Units 67 Re

19、quirements .68 Test methods 99 Information supplied by the manufacturer 19Annex A (informative) Bibliography . 22Annex ZA (informative) #Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$ . 23DIN EN 1060-3:2010-03 EN 1060-3:1997+A

20、2:2009 (E) 3 Foreword This document (EN 1060-3:1997+A2:2009) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text

21、or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by May 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 id

22、entifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2005-11-24 and Amendment 2, approved by CEN on 2009-10-17. This document supersedes EN 1060-3:1997. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“ and

23、# $. 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 with EU Directive(s), see informative Annex ZA, which is an integral part of this document. T

24、his European Standard Non-invasive sphygmomanometers consists of the following parts: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems This European Standard has

25、 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 93/42/EEC. #Annexes A and ZA are given for information and do not form normative parts of this European Standard.$ According to the CEN/

26、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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

27、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. DIN EN 1060-3:2010-03 EN 1060-3:1997+A2:2009 (E) 4 1 Scope This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood p

28、ressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm, the wrist and the thigh. It also specifies requirements for their accessories and gives test methods. This Part of EN 1060 applies to electro-mechanical

29、blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment

30、are specified in EN 60601-2-30:1995. This Part of EN 1060 is to be used in conjunction with EN 1060-1. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the t

31、ext and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to appl

32、ies. #deleted text$ EN 1060-1:1995, Non-invasive sphygmomanometers Part 1: General requirements EN 1060-2:1995, Non-invasive sphygmomanometers Part 2: Supplementary requirements for mechanical sphygmomanometers !EN 1060-4:2004, Non-invasive sphygmomanometers Part 4: Test procedures to determine the

33、overall system accuracy of automated non-invasive sphygmomanometers“ #EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance$ #EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential per

34、formance Collateral standard: Electromagnetic compatibility Requirements and tests$ #EN 60601-1-8, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electri

35、cal equipment and medical electrical systems$ !EN 60601-2-30:2000, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999)“ 3 Definitions !For the purp

36、oses of this document, the terms and definitions given in EN 1060-1:1995, EN 1060-2:1995, #EN 60601-1:2006$ and the following apply.“ DIN EN 1060-3:2010-03 EN 1060-3:1997+A2:2009 (E) 5 3.1 auscultatory method technique whereby sounds (known as Korotkov sounds) are heard over an occluded artery as th

37、e occluding pressure is slowly released, the appearance of sounds coinciding with systolic and the disappearance of sounds with diastolic blood pressure 3.2 electro-mechanical blood pressure measuring system system that consists of: a) at least one cuff, which is connected to the pneumatic system; b

38、) at least one electro-mechanical transducer to measure cuff pressure; c) at least one measured value display; d) if needed, signal inputs and outputs. 3.3 electro-mechanical pressure transducer component that transforms pressure signals into electrical signals 3.4 oscillometric method method wherei

39、n a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced NOTE During the inflation and deflation of the cuff small pressure changes (oscillations) occur in the cuff as a result of th

40、e arterial blood pressure pulses. These oscillations, which first increase and then decrease, are detected and stored together with the corresponding cuff pressure values in the measurement system. With these stored values the systolic, diastolic and mean arterial blood pressure values can be mathem

41、atically derived using an appropriate algorithm. It is possible to carry out the measurement during the inflation phase 3.5 zero setting procedure that corrects a deviation of the pressure reading to 0 mmHg at atmospheric pressure (gauge pressure: 0 mmHg) 3.6 patient simulator device for simulating

42、the oscillometric cuff pulses and/or auscultatory sounds during inflation and deflation NOTE This device is not used for testing accuracy but is required in assessing stability of performance. ! 3.7 short term automatic mode mode in which as many automatic measurements as possible are made within a

43、specified time period“ 4 Cuff Clause 4 of EN 1060-1:1995 shall apply. DIN EN 1060-3:2010-03 EN 1060-3:1997+A2:2009 (E) 6 5 Display Clause 5 of EN 1060-1:1995 shall apply. 6 Units Clause 6 of EN 1060-1:1995 shall apply. 7 Requirements 7.1 General Equipment or parts thereof, using materials or having

44、forms of construction different from those detailed in this Part of EN 1060, shall be accepted if it can be demonstrated that an equivalent degree of safety and performance is obtained. 7.2 Limits of the error of the cuff pressure indication 7.1.1 of EN 1060-1:1995 shall apply. 7.3 Effect of voltage

45、 variations of the power source variations 7.3.1 Internal electrical power source a) !Automated, cyclical measuring non-invasive blood pressure systems in which the cuff pressure is generated by an electrical pump shall comply with 56.7 c) 1) and 2) of EN 60601-2-30:2000;“ b) !Non-cyclical measuring

46、 non-invasive blood pressure systems in which the cuff pressure is generated by an electrical pump shall comply with 56.7 c) 2) of EN 60601-2-30:2000;“ c) Outside of the working range, no cuff pressure reading and no result of the blood pressure measurement shall be displayed. Testing shall be carri

47、ed out in accordance with 8.2.1 and 8.3.1. 7.3.2 External electrical power source a) !Blood pressure measuring systems in which the cuff pressure is generated by an electrical pump shall comply with 49.3 of EN 60601-2-30:2000;“ b) !For devices operated in manual mode 49.3 a) only applies.“ Testing s

48、hall be carried out in accordance with 8.2.2 and 8.3.2 (alternating current) or 8.2.3 and 8.3.3 (direct current). c) Incorrect values resulting from voltage variations outside the limits given in 7.3.2 b) shall not be displayed. Testing shall be carried out in accordance with 8.2.4 (alternating curr

49、ent) or 8.2.5 (direct current). DIN EN 1060-3:2010-03 EN 1060-3:1997+A2:2009 (E) 7 7.4 Pneumatic system 7.4.1 Air leakage Air leakage shall not exceed a pressure drop of 6 mmHg/min (0,8 kPa/min). For those devices in which the blood pressure is determined manually with the aid of a stethoscope the air leakage shall not exceed a pressure drop of 4 mmHg/min (0,5 kPa/min). Testing shall be carried out in accordance with 8.4. 7.4.2 Pressure reducing system for devices using the auscultatory method The