Dansk standard DS/EN 1060-4 1. udgave 2004-10-22 Ikke-invasive blodtryksmålere Del 4: Prøvningsmetoder til bestemmelse af nøjagtigheden af et system med automatiserede ikke-invasive blodtryksmålere Non-invasive sphygmomanometers Part 4: Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers
DS/EN 1060-4 København DS projekt: 52023 ICS: 11.040.55 Deskriptorer: blodtryk,kliniske undersøgelser,diagnostisk udstyr Første del af denne publikations betegnelse er: DS/EN, hvilket betyder, at det er en europæisk standard, der har status som dansk standard. Denne publikations overensstemmelse er: IDT med: EN 1060-4:2004. DS-publikationen er på engelsk. DS-publikationstyper DANSK STANDARD udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard eller standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard DS-information publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en teknisk rapport, eller europæisk præstandard DS-håndbog samling af standarder, eventuelt suppleret med informativt materiale DS-hæfte publikation med informativt materiale Til disse publikationstyper kan endvidere udgives tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis fuldtekstpublikation (publikationen er trykt i sin helhed) godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) elektronisk (publikationen leveres på et elektronisk medie) DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr. fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet at A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD IDT: Når publikationen er identisk med en given publikation. EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men præsentationen er ændret. NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en given standard, men udarbejdet på baggrund af denne. MOD: Når publikationen er modificeret i forhold til en given publikation.
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 1060-4 September 2004 ICS 11.040.55 English version Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated noninvasive sphygmomanometers Tensiomètres non invasifs - Partie 4 : Procédures pour déterminer la précision de l'ensemble du système des tensiomètres non invasifs automatiques This European Standard was approved by CEN on 9 July 2004. Nichtinvasive Blutdruckmessgeräte - Teil 4: Prüfverfahren zur Bestimmung der Messgenauigkeit von automatischen nichtinvasiven Blutdruckmessgeräten 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 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 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1060-4:2004: E
Contents Foreword...4 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 method...6 4.4 Application 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 General...9 4.6.2 Non-invasive reference measurement...9 4.6.3 Invasive reference measurement...10 4.7 Cuff size...10 4.8 Procedure...10 4.9 Evaluation of results...10 4.9.1 General...10 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 - 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 same upper arm at rest and under physical load...18 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 Evaluation...19 5.5.3 Documentation...19 5.6 Test method N6 - ambulatory blood pressure measurement on the opposite arms...19 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 Evaluation...20 2
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 measurement on the same arm...23 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 E (informative) A deviations...30 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC Medical Devices...31 Bibliography...32 3
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, 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 latest 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 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 Part 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 countries 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, Switzerland and United Kingdom. 4
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 referenced 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 requirements. 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 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 definitions given in EN 1060 1:1995 and EN 1060 3:1997 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 under 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. 5