SIST EN 1060-3:2000+A2:2010
(Main)Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
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 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 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 are specified in EN 60601-2-30:1995. This Part of EN 1060 is to be used in conjunction with EN 1060-1.
Nichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische Blutdruckmesssysteme
Dieser Teil der EN 1060 legt Anforderungen hinsichtlich der Gebrauchstauglichkeit, Messsicherheit und
Sicherheit für elektromechanische Blutdruckmesssysteme fest, die zur nichtinvasiven Messung des arteriellen
Blutdrucks am Oberarm, am Handgelenk und am Oberschenkel eine aufblasbare Manschette verwenden. Er
legt auch Anforderungen für deren Zubehör und der Prüfverfahren fest.
Dieser Teil der EN 1060 gilt für elektromechanische Blutdruckmesssysteme, bei denen der Manschettendruck
elektronisch gemessen wird, der Blutdruck jedoch entweder manuell mit Hilfe eines Stethoskops oder
automatisch bestimmt werden kann.
Zusätzliche Anforderungen an die Sicherheit von automatischen, periodischen, indirekt messenden BlutdruckÜberwachungsgeräten
legt EN 60601-2-30:2000 fest.
Dieser Teil der EN 1060 ist in Verbindung mit EN 1060-1 anzuwenden.
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguine
La présente partie de la norme EN 1060 spécifie les exigences en matière de performance, efficacité et sécurité
requises pour les systèmes électromécaniques de mesure de la pression sanguine qui, au moyen d'un brassard
gonflable, sont utilisés pour la mesure non invasive de la pression sanguine artérielle. Elle spécifie également les
exigences pour leurs accessoires et décrit les méthodes d'essai.
La présente partie de la norme EN 1060 s'applique aux systèmes électromécaniques de mesure de la pression
sanguine, dans lesquels la pression du brassard est mesurée électroniquement, mais qui permettent de déterminer
la pression sanguine soit manuellement à l'aide d'un stéthoscope, soit automatiquement.
L'EN 60601-2-30:1995 spécifie des exigences de sécurité complémentaires pour les appareils de surveillance de la
pression sanguine relevée indirectement, automatiquement et périodiquement.
La présente partie de l'EN 1060 doit être utilisée conjointement à la norme EN 1060-1.
Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za avtomatizirane sisteme za merjenje krvnega tlaka
Ta del EN 1060 določa zahteve za zmogljivost, učinkovitost in varnost elektromehanskih sistemov za merjenje krvnega tlaka, ki se s pomočjo napihljive manšete uporabljajo za neinvazivno merjenje arterijskega krvnega tlaka na nadlahti, zapestju in stegnu. Določa tudi zahteve za njihove dodatke in podaja preskusne metode. Ta del EN 1060 velja za elektromehanske sisteme za merjenje krvnega tlaka, pri katerih se tlak v manšeti meri elektronsko, vendar pa se krvi tlak lahko določa ročno s stetoskopom ali avtomatsko. Dodatne varnostne zahteve za opremo za avtomatski, ciklični posredni nadzor krvnega tlaka določa EN 60601-2-30:1995. Ta del EN 1060 se mora uporabljati v povezavi z EN 1060-1.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neinvazivni sfigmomanometri - 3. del: Dodatne zahteve za avtomatizirane sisteme za merjenje krvnega tlakaNichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für elektromechanische BlutdruckmesssystemeTensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguineNon-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 1060-3:1997+A2:2009SIST EN 1060-3:2000+A2:2010en,fr,de01-marec-2010SIST EN 1060-3:2000+A2:2010SLOVENSKI
STANDARD
SIST EN 1060-3:2000+A2:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE 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
Tensiomètres non invasifs - Partie 3: Exigences complémentaires concernant les systèmes électromécaniques de mesure de la pression sanguine
Nichtinvasive Blutdruckmessgeräte - Teil 3: Ergänzende Anforderungen für 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 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 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 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 national Members. Ref. No. EN 1060-3:1997+A2:2009: ESIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 2 Contents Page Foreword .31Scope .42Normative references .43Definitions .44Cuff .55Display .66Units .67Requirements .68Test methods .99Information 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$$$$ . 23 SIST EN 1060-3:2000+A2:2010
EN 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-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 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 identifying 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 # $. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. This European Standard 'Non-invasive sphygmomanometers' consists of the following parts: Part 1: General requirements Part 2: Supplementary requirements for mechanical sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC. #Annexes A and ZA are given for information and do not form normative parts of this European Standard.$ According to the CEN/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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
SIST EN 1060-3:2000+A2:2010
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 pressure 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 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 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 text 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 applies. #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 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 performance — 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 electrical 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 purposes 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." SIST EN 1060-3:2000+A2:2010
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 the 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) 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 wherein 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 the 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 mathematically 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 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 specified time period" 4 Cuff Clause 4 of EN 1060-1:1995 shall apply. SIST EN 1060-3:2000+A2:2010
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 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 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 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 carried 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 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). 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). SIST EN 1060-3:2000+A2:2010
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 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 systolic 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 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 systems 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 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). Testing shall be carried out in accordance with 8.7 and 8.8. 7.5 Environmental performance 7.5.1 Storage Blood pressure measuring systems shall maintain the requirements specified in this Part of EN 1060 after storage for 24 h at a temperature of - 5 ûC and for 24 h at a temperature of + 50 ûC and a Relative Humidity of 85 % (non-condensing). Testing shall be carried out at environmental conditions (see subclause 7.1.1 of EN 1060-1:1995) in accordance with 8.1 of EN 1060-1:1995 after the test sample has been placed for 24 h at a temperature of - 5 ûC and immediately afterwards for 24 at a temperature of + 50 ûC in a climatic chamber. SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 8 NOTE Integrated multiparameter monitors may contain components which can be damaged during storage. The general temperature range in EN 1060-1:1995 has therefore been reduced. 7.5.2 Temperature, relative humidity 7.1.2.2 of EN 1060-1:1995 shall apply. The signal processing for the determination of the blood pressure values shall not be influenced within the range of temperature and Relative Humidity specified in 7.1.2.2 of EN 1060-1:1995. Testing shall be carried out in accordance with 8.9. 7.5.3 Electromagnetic compatibility Either: a) Electrical and/or electromagnetic interferences shall not lead to degradations in the cuff pressure indication or in the result of the blood pressure measurement, or; b) If electrical and/or electromagnetic interferences lead to an abnormality, the abnormality shall be clearly indicated and it shall be possible to restore normal operation within 30 s after cessation of the electromagnetic disturbance. Testing shall be carried out in accordance with #EN 60601-1-2$. 7.6 Stability of the cuff pressure indication The change of the cuff pressure indication shall not be more than 3 mmHg (0,4 kPa) throughout the pressure range after 10 000 stimulated measurement cycles. Testing shall be carried out in accordance with 8.10. 7.7 Pressure indicating device 7.7.1 Nominal range and measuring range The nominal range for the cuff pressure measurement shall be specified by the manufacturer. The measuring and indication ranges of the cuff pressure shall be equal to the nominal range. Values of blood pressure measurement results outside the nominal range of cuff pressure shall be clearly indicated as out of range. Testing shall be carried out by visual inspection. 7.7.2 Digital indication The numerical step shall be 1 mmHg (0,1 kPa). #Numbers shall be clearly legible in accordance with 7.1.2 of EN 60601-1:2006.$ If the measured value of a parameter is to be indicated on more than one display, all the displays shall indicate the same numerical value. Measured, numerical values on the display(s), and the symbols defining the units of measurement shall be arranged in such a way so as to avoid misinterpretation. Testing shall be carried out by visual inspection. SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 9 7.8 Signal input and output parts The construction of the signal input and output parts (excluding internal interfaces, e.g. microphone signal input) relevant to the non-invasive blood pressure measurement shall ensure that incorrectly fitted or defective accessories shall not result in erroneous indication of cuff pressure or erroneous indication of blood pressure. Testing shall be carried out in accordance with 8.11. 7.9 Overall system accuracy !Except for short term automatic mode and devices in which blood pressure is determined manually with the aid of a stethoscope, the following overall system accuracy values shall apply: a) maximum mean error of measurement: ± 5 mmHg (± 0,7 kPa); b) maximum experimental standard deviation: 8 mmHg (1,1 kPa). Testing shall be performed in accordance with EN 1060-4. Upon request the manufacturer shall provide evidence to the Notified Body that these requirements are met." 7.10 Alarms If alarms are used, they shall be of at least medium priority and shall comply with #EN 60601-1-8$. 7.11 Safety 7.11.1 Cuff pressure It shall be possible to abort any blood pressure measurement at any time by single key operation and this shall lead to a rapid exhaust (see 7.4.3). Testing shall be carried out in accordance with 8.12. 7.11.2 Unauthorised access All controls that affect accuracy shall be sealed against unauthorised access. Testing shall be carried out by visual inspection. 7.11.3 Tubing connectors Luer lock connectors shall not be used. NOTE In order to avoid possible misconnection with intravascular systems Luer slip connectors should not be used. 8 Test methods 8.1 General An uncertainty of 1 mmHg (0,1 kPa) for digital indications shall be allowed in any displayed value because the display system cannot indicate a change of less than one unit. SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 10 8.2 Test methods for the effect of voltage variations of the power source on the cuff pressure reading. 8.2.1 Internal electrical power source 8.2.1.1 Apparatus a) Adjustable direct current voltage supply; b) Voltmeter with an error of less than 0,5 % of the measured value; c) Calibrated reference manometer with an error of less than 0,8 mmHg (0,1 kPa). 8.2.1.2 Procedure Substitute the internal electrical power source of the blood pressure measuring system by a dc voltage supply (8.2.1.1a)) with an impedance which is equivalent to the impedance of the internal electrical power source specified by the manufacturer. Test devices intended to be used with consumer batteries by use of an impedance of less than 1Ω. Measure the variation in applied dc voltage supply with a voltmeter (8.2.1.1b)). Test the blood pressure measuring system by altering the dc voltage supply in steps of 0,1 V and determine the lowest voltage limit at which the cuff pressure reading is still displayed. Carry out the test with the maximum permissible impedance of the internal electrical power source. Carry out the test according to the procedure specified in 8.1 of EN 1060-1:1995 at the lowest voltage limit increased by 0,1 V and also at the nominal voltage. 8.2.1.3 Expression of results Express the results as the difference between the cuff pressure indication of the blood pressure measuring system to be tested and the reference manometer (8.2.1.1c) at the lowest voltage limit increased by 0,1 V and at the nominal voltage. 8.2.2 External electrical power source – alternating current 8.2.2.1 Apparatus a) Adjustable alternating current voltage supply; b) Voltmeter with an error of less than 0,5 % of the measured value; c) Calibrated reference manometer with an error of less than 0,8 mmHg (0,1 kPa). 8.2.2.2 Procedure Connect the blood pressure measuring system to the ac voltage supply (8.2.2.1a)). Measure the variation in ac voltage supply with the voltmeter (8.2.2.1b)). Carry out the test according to the procedure specified in 8.1 of EN 1060-1:1995 at: a) The maximum rated voltage declared by the manufacturer, increased by 10 %; b) The mean value of the maximum and minimum rated voltages declared by the manufacturer; SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 11 c) The minimum rated voltage declared by the manufacturer, decreased by 10 %. 8.2.2.3 Expression of results Express the results as the difference between the cuff pressure indication of the blood pressure measuring system to be tested and the reference manometer (8.2.2.1c)). 8.2.3 External electrical power source – direct current 8.2.3.1 Apparatus Use the apparatus listed in 8.2.1.1. 8.2.3.2 Procedure Connect the blood pressure measuring system with the dc voltage supply (8.2.1.1a)). Control the dc voltage supply by reference to a voltmeter (8.2.1.1b)). Carry out the test according to the procedure specified in 8.1 of EN 1060-1:1995 at: a) The maximum rated voltage declared by the manufacturer, increased by 10 %; b) The mean value of the maximum and minimum rated voltages declared by the manufacturer; c) The minimum rated voltage declared by the manufacturer, decreased by 10 %. 8.2.3.3 Expression of results Express the results as the difference between the cuff pressure indication of the blood pressure measuring system to be tested and the reference manometer (8.2.1.1c)). 8.2.4 Voltage variations of the external electrical power source – alternating current 8.2.4.1 Apparatus Use the apparatus listed in 8.2.2.1. 8.2.4.2 Procedure Connect the blood pressure measuring system with the ac voltage supply (8.2.2.1a)). Measure the variation in the ac voltage supply with the voltmeter (8.2.2.1b)). Test the blood pressure measuring system by altering the ac voltage supply in steps of 5 V and determine the lowest voltage limit at which the cuff pressure reading is displayed. Carry out the test according to the procedure specified in 8.1 of EN 1060-1:1995 at the lowest voltage limit increased by 5 V and also at the rated voltage. 8.2.4.3 Expression of results Express the results as differences between the cuff pressure indication at the blood pressure measuring system to be tested and the reference manometer (8.2.2.1c)) at the rated voltage and the lowest voltage limit increased by 5 V. SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 12 8.2.5 Voltage variations of the external electrical power source – direct current 8.2.5.1 Apparatus Use the apparatus listed in 8.2.1.1. 8.2.5.2 Procedure Connect the blood pressure measuring system with the dc voltage supply (8.2.1.1a)). Measure the variation in the dc voltage supply with the voltmeter (8.2.1.1b)). Test the blood pressure measuring system by altering the dc voltage supply in steps of 0,1V and determine the lowest voltage limit at which the cuff pressure reading is displayed. Carry out the test according to the procedure specified in 8.1 of EN 1060-1:1995 at the lowest voltage limit increased by 0,1 V and also at the rated voltage. 8.2.5.3 Expression of results Express the results as the differences between the cuff pressure indication of the blood pressure measuring system to be tested and the reference manometer (8.2.1.1c)) at the rated voltage limit increased by 0,1 V. 8.3 Test methods for the effect of voltage variations of the power source on the result of the blood pressure measurement. 8.3.1 Internal electrical power source 8.3.1.1 Apparatus a) Adjustable direct current voltage supply; b) Voltmeter with an error less than 0,5 % of the measured value; c) Patient simulator for the auscultatory and/or oscillometric method, having additional deviations originating from the simulator of not more than 2 mmHg (0,27 kPa) for the mean value of the measurements, and generating signals for blood pressure values of approximately: Systolic:
120 mmHg (16,0 kPa) Diastolic: 80 mmHg (10,7 kPa) Pulse rate: 70 min-1 to 80 min-1. 8.3.1.2 Procedure Substitute the internal electrical power source of the blood pressure measuring system with a dc voltage supply (8.3.1.1a)) with an impedance which is equivalent to the impedance of the internal electrical power source specified by the manufacturer. Test devices intended to be used with consumer batteries by use of an impedance of less than 1Ω. Control the dc voltage supply by reference to a voltmeter (8.3.1.1b)). Connect the blood pressure measuring system to the patient simulator (8.3.1.1c)). Carry out the test at the maximum permissible impedance of the internal electrical power source. SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 13 Carry out 20 simulated blood pressure measurements at the lowest voltage limit as determined in 8.2.1.2 increased by 0,1 V and at nominal voltage. 8.3.1.3 Expression of results Determine the mean value (systolic and diastolic values separately) of the 20 consecutive readings taken at each voltage level. 8.3.2 External electrical power source – alternating current 8.3.2.1 Apparatus a) Adjustable alternating current voltage supply; b) Voltmeter with an error less than 0,5 % of the measured value; c) Patient simulator as described in 8.3.1.1c)). 8.3.2.2 Procedure Connect the blood pressure measuring system to the ac voltage supply (8.3.2.1a)). Control the ac voltage supply by reference to a voltmeter (8.3.2.1b)). Connect the blood pressure measuring system to the simulator (8.3.2.1c)). Carry out 20 simulated blood pressure measurements each at: a) The maximum rated voltage declared by the manufacturer, increased by 10 %; b) The mean value of the maximum and minimum rated voltages declared by the manufacturer; c) The minimum rated voltage declared by the manufacturer, decreased by 10 %. 8.3.2.3 Expression of results Determine the mean value (systolic and diastolic values separately) of the 20 consecutive readings taken at each voltage level. 8.3.3 External electrical power source – direct current 8.3.3.1 Apparatus a) Adjustable direct current voltage supply; b) Voltmeter with an error less than 0,5 % of the measured value; c) Patient simulator as described in 8.3.1.1c). 8.3.3.2 Procedure Connect the blood pressure measuring system to the dc voltage supply (8.3.3.1a)). Control the dc voltage supply by reference to a voltmeter (8.3.3.1b)). Connect the blood pressure measuring system to the simulator (8.3.3.1c)). Carry out 20 simulated blood pressure measurements each at: SIST EN 1060-3:2000+A2:2010
EN 1060-3:1997+A2:2009 (E) 14 a) The maximum rated voltage declared by the manufacturer, increased by 10 %. b) The mean value of the maximum and minimum rated voltages declared by the manufacturer; c) The minimum rated voltage declared by the manufacturer, decreased by 10 %. 8.3.3.3 Expression of results Determine the mean value (systolic and diastolic values separately) of the 20 consecutive readings taken at each voltage level. 8.4 Test method for the air leakage of the pneumatic system 8.4.1 Apparatus a) Rigid metal cylinder; b) Pressure generator, e.g. ball pump (hand pump) with pressure relief valve; c) Stopwatch. 8.4.2 Procedure 8.4.2.1 If, because of technical reasons, the test as described in 8.4.2 cannot be performed, use an alternative test procedure specified by the manufacturer. 8.4.2.2 Carry out the test at constant temperature in the range 15 ûC to 25 ûC. 8.4.2.3 Before beginning the test, allow the blood pressure measuring system to reach working temperature. 8.4.2.4 Wrap the cuff around a cylinder (8.4.1a)) of
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