1、BRITISH STANDARD BS EN 1060-4:2004 Non-invasive sphygmomanometers Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers The European Standard EN 1060-4:2004 has the status of a British Standard ICS 11.040.55 BS EN 1060-4:2004 This British Standa
2、rd was published under the authority of the Standards Policy and Strategy Committee on 6 October 2004 BSI 6 October 2004 ISBN 0 580 44542 9 National foreword This British Standard is the official English language version of EN 1060-4:2004. The UK participation in its preparation was entrusted by Tec
3、hnical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/10, Sphygmomanometers, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement internation
4、al or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to
5、 include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any
6、enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 32, an ins
7、ide back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN10604 September2004 ICS11.040.55 Englishversion Noninvasivesphy
8、gmomanometersPart4:Testproceduresto determinetheoverallsystemaccuracyofautomatednon invasivesphygmomanometers TensiomtresnoninvasifsPartie4:Procdurespour dterminerlaprcisiondelensembledusystmedes tensiomtresnoninvasifsautomatiques NichtinvasiveBlutdruckmessgerteTeil4:Prfverfahren zurBestimmungderMes
9、sgenauigkeitvonautomatischen nichtinvasivenBlutdruckmessgerten ThisEuropeanStandardwasapprovedbyCENon9July2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbi
10、bliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnoti
11、fiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovaki
12、a, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN1060
13、4:2004:EEN 1060-4:2004 (E) 2 Contents Foreword4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements.6 4.1 General information on the non-invasive reference methods 6 4.2 General information on the invasive reference methods 6 4.3 Selection of clinical test method6 4.4 Applic
14、ation of test method .7 4.4.1 Non-invasive reference measurement.7 4.4.2 Invasive reference measurement.8 4.5 Test equipment 8 4.5.1 Non-invasive reference measurement.8 4.5.2 Invasive blood pressure measurement .8 4.6 Subjects 9 4.6.1 General9 4.6.2 Non-invasive reference measurement.9 4.6.3 Invasi
15、ve reference measurement.10 4.7 Cuff size 10 4.8 Procedure .10 4.9 Evaluation of results .10 4.9.1 General10 4.9.2 Non-invasive reference measurement.11 4.9.3 Documentation.13 5 Non-invasive test methods .13 5.1 Test method N1 - simultaneous blood pressure measurement on the same upper arm.13 5.1.1
16、Procedure .13 5.1.2 Evaluation.14 5.2 Test method N2 - blood pressure measurement on the opposite arms 14 5.2.1 Procedure .14 5.2.2 Evaluation.16 5.2.3 Documentation.16 5.3 Test method N3 - sequential blood pressure measurement on the same arm .17 5.3.1 Procedure .17 5.3.2 Evaluation.18 5.4 Test met
17、hod N4 - simultaneous blood pressure measurement on the same upper arm at rest and under physical load18 5.4.1 Procedure .18 5.4.2 Evaluation.18 5.4.3 Documentation.18 5.5 Test method N5 - ambulatory blood pressure measurement on the same upper arm.18 5.5.1 Procedure of measurement 18 5.5.2 Evaluati
18、on.19 5.5.3 Documentation.19 5.6 Test method N6 - ambulatory blood pressure measurement on the opposite arms19 5.6.1 Procedure .19 5.6.2 Evaluation.20 5.6.3 Documentation.20 6 Invasive test methods .20 6.1 Test method I 1 - invasive blood pressure measurement on adults 20 6.1.1 Procedure .20 6.1.2 E
19、valuation.20 EN 1060-4:2004 (E) 3 6.1.3 Documentation.21 6.2 Test method I 2 - invasive blood pressure measurement on neonates and infants.21 6.2.1 Procedure .21 6.2.2 Evaluation.21 6.2.3 Documentation.22 Annex A (informative) Chronological order of the test method N 3 Sequential blood pressure meas
20、urement on the same arm23 Annex B (informative) Example of a record of a clinical investigation according to method N1 or N3.24 Annex C (informative) Summary of the WHO recommendations for auscultatory blood pressure measurement .27 Annex D (informative) Observer training and assessment etc.28 Annex
21、 E (informative) Adeviations 30 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC Medical Devices.31 Bibliography32 EN 1060-4:2004 (E) 4 Foreword This document (EN 1060-4:2004) has been prepared by Technical Committee CEN/TC 20
22、5 “Non-active medical devices”, the secretariat of 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 March 2005, and conflicting national standards shall be withdrawn at the la
23、test by March 2005. 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, see informative Annex ZA, which is an integral part of this
24、 document. EN 1060 consists of the following Parts under the general title “Non-invasive sphygmomanometers”: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems Par
25、t 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers Annexes A, B, C, D, E and ZA are informative. This document includes a Bibliography. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following coun
26、tries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzer
27、land and United Kingdom. EN 1060-4:2004 (E) 5 1 Scope This document describes test procedures for investigations to determine the overall system accuracy of automated non-invasive sphygmomanometers, designed for the indirect measurement of blood pressure. 2 Normative references The following referen
28、ced 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. EN 1060-1:1995, Non-invasive sphygmomanometers Part 1: General require
29、ments. EN 1060-2, Non-invasive sphygmomanometers Part 2: Supplementary requirements for mechanical sphygmomanometers. EN 1060-3:1997, Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. EN ISO 14155-1, Clinical investigation of
30、 medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003). EN ISO 14155-2, Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003). 3 Terms and definitions For the purposes of this document, the terms and defi
31、nitions given in EN 10601:1995 and EN 10603:1997 and the following apply. 3.1 neonatal mode mode, specified by the manufacturer of the sphygmomanometer for the measurement of neonates/infants 3.2 paired measurements parallel blood pressure measurements carried out by the observers and the device und
32、er test at the same arm at the same time or on opposite arms at the same time or at the same arm at different times or at one arm and another limb, at the same time or at different times. EN 1060-4:2004 (E) 6 4 Requirements 4.1 General information on the non-invasive reference methods The clinical i
33、nvestigation shall be performed in accordance with EN ISO 141551 and EN ISO 141552. The auscultatory blood pressure measurements described shall be carried out by two observers by means of a double stethoscope. The auscultatory reference value will then be the mean value of the two values determined
34、 by the observers. The difference between both values shall not exceed 4 mmHg. Any measurements with observer-to- observer differences greater than 4 mmHg shall not be included in the data set. The number of discarded measurements shall not be greater than the number of the required valid measuremen
35、ts. NOTE 1 Reading of the values on the reference manometer should be as accurate as possible. When reading the value on the reference manometer(s) the observers should avoid parallax errors. Rounding to zero and five has a negative effect on the result of the investigation. More information and rec
36、ommendations are given in annex D. The calibrated reference manometers shall comply with the requirements of EN 1060-1 to EN 1060-3 but shall not exceed error limits of 1 mmHg (0,1 kPa) with dropping cuff pressure prior to the start of the clinical investigation. NOTE 2 The reference manometer shoul
37、d be calibrated before and after the clinical investigation. When the reference manometer is linked to the pneumatic system of the tested device (e.g. test method N2), an aneroid manometer should be used. Mercury manometer may alter pneumatic characteristics (resonant frequency, damping coefficient)
38、 and should not be used in this case. 4.2 General information on the invasive reference methods The clinical investigation shall be performed in accordance with EN ISO 141551 and EN ISO 141552. The invasive blood pressure measuring system consisting of catheter, pressure transducer, monitor and reco
39、rding device shall be statically calibrated so that the indicated values do not deviate from the values indicated by the reference manometer (see 4.5.1.1 a) by more than 2 mmHg. Prior to and after each series of measurements the resonant frequency and damping coefficient of the system shall be deter
40、mined 1. Except for devices measuring in the neonatal mode, the comparison shall be carried out by invasive and non- invasive blood pressure measurement on the same arm. The simultaneous measurement on opposite arms is permissible if no lateral difference has been determined by additional measuremen
41、ts. NOTE Intra-arterial methods are invasive and should not be used for patients or subjects solely for the purpose of validating instrument performance, but conducted on clinical patients in whom an intra-arterial line has already been placed for reasons other than sphygmomanometer verification. 4.
42、3 Selection of clinical test method The selection of the clinical test method is dependent on the measurement technique, the application of the sphygmomanometers to be tested and the intended application of the device and shall be in accordance with Table 1. EN 1060-4:2004 (E) 7 Table 1 Matrix for t
43、he selection of the clinical test method Reference method Measurement technique of the device to be tested Clinical test method as a function of application adults neonatal mode ergo. aABPM bContinuous pressure drop or pressure drop in steps (upper arm measurement) 3 mmHg/s or 3 mmHg/pulse c 3 mmHg/
44、s or 3 mmHg/pulse cN1/N2/N3 N2/N3 - - N4 - N5/N6 N6 Measurement on other sites than the upper arm N2/N3 Auscultatory measurement at the upper arm Measurement during inflation phase N2/N3 - - N6 Invasive measurement Measurement during the pressure drop or the inflation phase I 1 I 2 - - a Ergometry (
45、measurement under physical load)b Ambulatory blood pressure measurement c For devices adapting to the pulse rate 4.4 Application of test method 4.4.1 Non-invasive reference measurement 4.4.1.1 Simultaneous blood pressure measurement on the same upper arm; also under physical load and ambulatory The
46、test methods (N1, N4, N5) for the simultaneous blood pressure measurement on the same upper arm are suitable for sphygmomanometers operating with continuous pressure drop (rate of pressure drop 3 mmHg/s) and/or with pressure drop in steps (rate of pressure drop per step 3 mmHg) and/or with a pulse-c
47、ontrolled pressure drop (rate of pressure drop 3 mmHg per pulse) These values apply for the range of the systolic and diastolic blood pressures. 4.4.1.2 Simultaneous blood pressure measurement on opposite arms The test methods (N2 and N6) for the simultaneous blood pressure measurement are suitable
48、for sphygmomanometers operating with continuous pressure drop and/or with pressure drop in steps and/or with a pulse-controlled pressure drop. This test method is also suitable for sphygmomanometers measuring during the inflation phase or measuring on other sites then upper arm. EN 1060-4:2004 (E) 8 4.4.1.3 Sequential blood pressure measurement The test methods (N3) for sequential blood pressure measurement are suitable for sphygmomanometers operating with continuous pressure drop and/or with pressure
