BS-EN-1060-4-2004.pdf
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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 ? Licensed Copy: sheffieldun sheffiel
2、dun, na, Thu Oct 26 04:53:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1060-4:2004 This British Standard 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 offi
3、cial English language version of EN 1060-4:2004. The UK participation in its preparation was entrusted by Technical 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 ca
4、n be obtained on request to its secretary. Cross-references The British Standards which implement international 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”
5、facility of the BSI Electronic Catalogue or of British Standards Online. 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 does not of itself confer immunity from legal obliga
6、tions. aid enquirers to understand the text; present to the responsible international/European committee any 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
7、 pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 32, an inside 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. DateComments Lic
8、ensed Copy: sheffieldun sheffieldun, na, Thu Oct 26 04:53:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1060-4 September 2004 ICS 11.040.55 English version Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system ac
9、curacy of automated non- invasive sphygmomanometers Tensiomtres non invasifs - Partie 4 : Procdures pour dterminer la prcision de lensemble du systme des tensiomtres non invasifs automatiques Nichtinvasive Blutdruckmessgerte - Teil 4: Prfverfahren zur Bestimmung der Messgenauigkeit von automatischen
10、 nichtinvasiven Blutdruckmessgerten This European Standard was approved by CEN on 9 July 2004. 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-da
11、te lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat 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
12、 responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
13、 Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36
14、 B-1050 Brussels 2004 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-4:2004: E Licensed Copy: sheffieldun sheffieldun, na, Thu Oct 26 04:53:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 1060-4:2004 (E) 2 Contents Foreword4
15、1 Scope 5 2 Normative references5 3 Terms and definitions .5 4 Requirements.6 4.1 General information on the non-invasive reference methods6 4.2 General information on the invasive reference methods6 4.3 Selection of clinical test method6 4.4 Application of test method .7 4.4.1 Non-invasive referenc
16、e 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 Subjects9 4.6.1 General9 4.6.2 Non-invasive reference measurement.9 4.6.3 Invasive reference measurement.10 4.7 Cuff size10 4.8 Proce
17、dure .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 Procedure .13 5.1.2 Evaluation.14 5.2 Test method N2 -
18、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 method N4 - simultaneous blood pressure measurement on the
19、 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 measurement18 5.5.2 Evaluation.19 5.5.3 Documentation.19 5.6 Test method N6 - ambula
20、tory 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 adults20 6.1.1 Procedure .20 6.1.2 Evaluation.20 Licensed Copy: sheffieldun sheffieldun, na,
21、Thu Oct 26 04:53:21 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 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 t
22、he test method N 3 Sequential blood pressure measurement 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 (informati
23、ve) Observer training and assessment etc.28 Annex E (informative) Adeviations30 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC Medical Devices.31 Bibliography32 Licensed Copy: sheffieldun sheffieldun, na, Thu Oct 26 04:53:21
24、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 1060-4:2004 (E) 4 Foreword This document (EN 1060-4:2004) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard,
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