1、BRITISH STANDARDBS EN Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systemsICS 11.040.55g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g
2、55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g581060-3:1997+A2:2009National forewordThis British Standard is the UK implementation of EN 1060-3:1997+A2:2009. It supersedes BS EN 1060-3:1997 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the
3、 text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/10, Sphyg
4、momanometers.A list of organizations represented on this subcommittee 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 conf
5、er immunity from legal obligations.BS EN 1060-3:1997+A2:2009This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1997 BSI 2010Amendments/corrigenda issued
6、since publicationAmd. No. Date Comments 16177 31 August 2006 Implementation of CEN amendment A1:200828 February 2010 Implementation of CEN amendment A2:2009ISBN 978 0 580 65150 2EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1060-3:1997+A2 November 2009 ICS 11.040.55 Supersedes EN 1060-3:1997E
7、nglish Version Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems Tensiomtres non invasifs - Partie 3: Exigences complmentaires concernant les systmes lectromcaniques de mesure de la pression sanguine Nichtinvasive Blutdruckmes
8、sgerte - Teil 3: Ergnzende Anforderungen fr elektromechanische Blutdruckmesssysteme This European Standard was approved by CEN on 27 January 1997 and includes Amendment 1 approved by CEN on 24 November 2005 and Amendment 2 approved by CEN on 17 October 2009. CEN members are bound to comply with the
9、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 bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre o
10、r 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 responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official ve
11、rsions. 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, Slovakia, Slovenia,
12、 Spain, Sweden, 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 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN nation
13、al 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 Requirements .68 Test methods 99 Information supplied by the manufacturer 19Annex A (informative) Bibliography . 22Annex ZA
14、 (informative) #Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$ . 23BS EN 1060-3:1997+A2:2009EN 1060-3:1997+A2:2009 (E) 3 Foreword This document (EN 1060-3:1997+A2:2009) has been prepared by Technical Committee CEN/TC 205 “Non-
15、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 or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by M
16、ay 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 identifying any or all such patent rights. This document includes Amendment 1, approved by CEN on 2005-11-24 and Amendme
17、nt 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 # $. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Tra
18、de Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. This European Standard Non-invasive sphygmomanometers consists of the following parts: Part 1: General requirements Par
19、t 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and su
20、pports essential requirements of EU Directive 93/42/EEC. #Annexes A and ZA are given for information and do not form normative parts of this European Standard.$ According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement t
21、his 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, Switzerland and Un
22、ited Kingdom. BS EN 1060-3:1997+A2:2009EN 1060-3:1997+A2:2009 (E) 4 1 Scope This Part of EN 1060 specifies performance, efficiency and safety requirements for electro-mechanical blood pressure measuring systems that, by means of an inflatable cuff are used for non-invasive measurements of arterial b
23、lood 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 blood pressure measuring systems in which the cuff pressure is measured electronically, but in which the blood pres
24、sure can be determined either manually with the aid of a stethoscope or automatically. Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment 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
25、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 text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any o
26、f 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 applies. #deleted text$ EN 1060-1:1995, Non-invasive sphygmomanometers Part 1: General requirements EN 1060-2:1995, Non
27、-invasive sphygmomanometers Part 2: Supplementary requirements for mechanical sphygmomanometers !EN 1060-4:2004, Non-invasive sphygmomanometers Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers“ #EN 60601-1:2006, Medical electrical equipment
28、 - 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 performance Collateral standard: Electromagnetic compatibility Requirements and tests EN 60601-1-8, Medical electrical e
29、quipment Part 1-8: General requirements for basic safety and essential performance Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems$ !EN 60601-2-30:2000, Medical electrical equipment Part 2-30: Particular r
30、equirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999)“ 3 Definitions !For the purposes of this document, the terms and definitions given in EN 1060-1:1995, EN 1060-2:1995, #EN 60601-1:2006$ and the fol
31、lowing apply.“ BS EN 1060-3:1997+A2:2009EN 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 the occluding pressure is slowly released, the appearance of sounds coinciding with systolic and the disappearance of
32、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) at least one electro-mechanical transducer to measure cuff pressure; c) at least one measured value display; d) if
33、 needed, signal inputs and outputs. 3.3 electro-mechanical pressure transducer component that transforms pressure signals into electrical signals 3.4 oscillometric method method wherein a cuff is placed on the limb and the pressure in the cuff is increased until the blood flow in the artery is inter
34、rupted 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 the arterial blood pressure pulses. These oscillations, which first increase and then decrease, are detected and store
35、d 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 mathematically derived using an appropriate algorithm. It is possible to carry out the measurement during the inflation ph
36、ase 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 the oscillometric cuff pulses and/or auscultatory sounds during inflation and deflation NOTE This device is not used
37、 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 specified time period“ 4 Cuff Clause 4 of EN 1060-1:1995 shall apply. BS EN 1060-3:1997+A2:2009EN 1060-3:1997+A2:2009
38、 (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 forms of construction different from those detailed in this Part of EN 1060, shall be accepted if it can be demons
39、trated 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 variations of the power source variations 7.3.1 Internal electrical power source a) !Automated, cyclical measurin
40、g 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 non-invasive blood pressure systems in which the cuff pressure is generated by an electrical pump shall comply wi
41、th 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 carried out in accordance with 8.2.1 and 8.3.1. 7.3.2 External electrical power source a) !Blood pressure measuring sys
42、tems 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 shall 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).
43、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 current) or 8.2.5 (direct current). BS EN 1060-3:1997+A2:2009EN 1060-3:1997+A2:2009 (E) 7 7.4 Pneumatic system 7.4.1 A
44、ir 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 accord
45、ance with 8.4. 7.4.2 Pressure reducing system for devices using the auscultatory method The pressure reducing system for manually operated and automated deflation valves shall be capable of maintaining a deflation rate of 2 mmHg/s to 3 mmHg/s (0,3 kPa/s to 0,4 kPa/s) within the target range of systo
46、lic and diastolic blood pressure. For devices which control the pressure reduction as a function of the pulse rate, a deflation rate of between 2 mmHg/pulse and 3 mmHg/pulse (0,3 kPa/pulse and 0,4 kPa/pulse) shall be maintained. NOTE Manually operated deflation valves should be easily adjustable to
47、these values. Testing shall be carried out in accordance with 8.5. 7.4.3 Rapid exhaust During the rapid exhaust of the pneumatic system with fully opened valve, the time for the pressure reduction from 260 mmHg to 15 mmHg (34,7 kPa to 2,0 kPa) shall not exceed 10 s. For blood pressure measuring syst
48、ems having the capability to measure in a neonatal/infant mode, the time for the pressure reduction from 150 mmHg to 5 mmHg (20,0 kPa to 0,7 kPa) during the rapid exhaust of the pneumatic system with fully opened valve shall not exceed 5 s. Testing shall be carried out in accordance with 8.6. 7.4.4
49、Zero setting Blood pressure measuring systems shall be capable of automatic zero setting. The zero setting shall be carried out at appropriate intervals, at least starting after switching on the device. At the moment of the zero setting a gauge pressure of 0 mmHg (0 kPa) shall exist and be displayed thereafter. Devices performing zero setting only immediately after switching on, shall switch off automatically before the drift of the pressure transducer and the analog signal processing exceeds 1 mmHg (0,1 kPa). T
