ICS Supersedes EN :1997. English Version

Transcription

1 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN :1997+A2 November 2009 ICS Supersedes EN :1997 English 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 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 :1997+A2:2009: E

2 Contents Page Foreword Scope...4 Normative references...4 Definitions...4 Cuff...5 Display...6 Units...6 Requirements...6 Test methods...9 Information supplied by the manufacturer Annex A (informative) Bibliography Annex ZA (informative) #Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices$

3 Foreword This document (EN :1997+A2:2009) has been prepared by Technical Committee CEN/TC 205 Nonactive 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 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 and Amendment 2, approved by CEN on This document supersedes EN :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. 3

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 :1995. This Part of EN 1060 is to be used in conjunction with EN 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 :1995, Non-invasive sphygmomanometers Part 1: General requirements EN :1995, Non-invasive sphygmomanometers Part 2: Supplementary requirements for mechanical sphygmomanometers!en :2004, Non-invasive sphygmomanometers Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers" #EN :2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance$ #EN , Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests$ #EN , 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$!en :2000, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC :1999)" 3 Definitions!For the purposes of this document, the terms and definitions given in EN :1995, EN :1995, #EN :2006$ and the following apply." 4

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 :1995 shall apply. 5

6 5 Display Clause 5 of EN :1995 shall apply. 6 Units Clause 6 of EN :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 of EN :1995 shall apply. 7.3 Effect of voltage variations of the power source variations 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 :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 :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 and 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 :2000;" b)!for devices operated in manual mode 49.3 a) only applies." Testing shall be carried out in accordance with and (alternating current) or and (direct current). c) Incorrect values resulting from voltage variations outside the limits given in b) shall not be displayed. Testing shall be carried out in accordance with (alternating current) or (direct current). 6

7 7.4 Pneumatic system 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 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 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 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 Environmental performance 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 C and for 24 h at a temperature of + 50 C and a Relative Humidity of 85 % (non-condensing). Testing shall be carried out at environmental conditions (see subclause of EN :1995) in accordance with 8.1 of EN :1995 after the test sample has been placed for 24 h at a temperature of - 5 C and immediately afterwards for 24 at a temperature of + 50 C in a climatic chamber. 7

8 NOTE Integrated multiparameter monitors may contain components which can be damaged during storage. The general temperature range in EN :1995 has therefore been reduced Temperature, relative humidity of EN :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 of EN :1995. Testing shall be carried out in accordance with 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 $. 7.6 Stability of the cuff pressure indication The change of the cuff pressure indication shall not be more than 3 mmhg (0,4 kpa) throughout the pressure range after stimulated measurement cycles. Testing shall be carried out in accordance with Pressure indicating device Nominal range and measuring range The nominal range for the cuff pressure measurement shall be specified by the manufacturer. The measuring and indication ranges of the cuff pressure shall be equal to the nominal range. Values of blood pressure measurement results outside the nominal range of cuff pressure shall be clearly indicated as out of range. Testing shall be carried out by visual inspection Digital indication The numerical step shall be 1 mmhg (0,1 kpa). #Numbers shall be clearly legible in accordance with of EN :2006.$ 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. 8

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 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 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 $ Safety 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 Unauthorised access All controls that affect accuracy shall be sealed against unauthorised access. Testing shall be carried out by visual inspection 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. 9

10 8.2 Test methods for the effect of voltage variations of the power source on the cuff pressure reading Internal electrical power source 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) Procedure Substitute the internal electrical power source of the blood pressure measuring system by a dc voltage supply ( a)) 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 ( b)). 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 :1995 at the lowest voltage limit increased by 0,1 V and also at the nominal voltage 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 ( c) at the lowest voltage limit increased by 0,1 V and at the nominal voltage External electrical power source alternating current 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) Procedure Connect the blood pressure measuring system to the ac voltage supply ( a)). Measure the variation in ac voltage supply with the voltmeter ( b)). Carry out the test according to the procedure specified in 8.1 of EN :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; 10

11 c) The minimum rated voltage declared by the manufacturer, decreased by 10 % 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 ( c)) External electrical power source direct current Apparatus Use the apparatus listed in Procedure Connect the blood pressure measuring system with the dc voltage supply ( a)). Control the dc voltage supply by reference to a voltmeter ( b)). Carry out the test according to the procedure specified in 8.1 of EN :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 % 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 ( c)) Voltage variations of the external electrical power source alternating current Apparatus Use the apparatus listed in Procedure Connect the blood pressure measuring system with the ac voltage supply ( a)). Measure the variation in the ac voltage supply with the voltmeter ( b)). 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 :1995 at the lowest voltage limit increased by 5 V and also at the rated voltage 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 ( c)) at the rated voltage and the lowest voltage limit increased by 5 V. 11

12 8.2.5 Voltage variations of the external electrical power source direct current Apparatus Use the apparatus listed in Procedure Connect the blood pressure measuring system with the dc voltage supply ( a)). Measure the variation in the dc voltage supply with the voltmeter ( b)). 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 :1995 at the lowest voltage limit increased by 0,1 V and also at the rated voltage 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 ( c)) 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 Internal electrical power source 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: Diastolic: 120 mmhg (16,0 kpa) 80 mmhg (10,7 kpa) Pulse rate: 70 min -1 to 80 min Procedure Substitute the internal electrical power source of the blood pressure measuring system with a dc voltage supply ( a)) 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 ( b)). Connect the blood pressure measuring system to the patient simulator ( c)). Carry out the test at the maximum permissible impedance of the internal electrical power source. 12

13 Carry out 20 simulated blood pressure measurements at the lowest voltage limit as determined in increased by 0,1 V and at nominal voltage Expression of results Determine the mean value (systolic and diastolic values separately) of the 20 consecutive readings taken at each voltage level External electrical power source alternating current 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 c)) Procedure Connect the blood pressure measuring system to the ac voltage supply ( a)). Control the ac voltage supply by reference to a voltmeter ( b)). Connect the blood pressure measuring system to the simulator ( c)). 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 % Expression of results Determine the mean value (systolic and diastolic values separately) of the 20 consecutive readings taken at each voltage level External electrical power source direct current 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 c) Procedure Connect the blood pressure measuring system to the dc voltage supply ( a)). Control the dc voltage supply by reference to a voltmeter ( b)). Connect the blood pressure measuring system to the simulator ( c)). Carry out 20 simulated blood pressure measurements each at: 13

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 % 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 Apparatus a) Rigid metal cylinder; b) Pressure generator, e.g. ball pump (hand pump) with pressure relief valve; c) Stopwatch Procedure If, because of technical reasons, the test as described in cannot be performed, use an alternative test procedure specified by the manufacturer Carry out the test at constant temperature in the range 15 C to 25 C Before beginning the test, allow the blood pressure measuring system to reach working temperature Wrap the cuff around a cylinder (8.4.1a)) of an appropriate size (see clause 4), such, for devices measuring at the upper arm and the thigh, that the circumference of the applied cuff does not exceed that of the cylinder by more than 7 %. NOTE 1 Electro-mechanical pumps which are a part of the system may be used for the test. Valves which are permanently opened may be disconnected for the test. NOTE 2 For this test no calibrated reference manometer is required because the cuff pressure display of the unit under test can be used when the error of the cuff pressure indication is taken into account. The advantage of this test is that the unit under test is in its original configuration. Additional connections can increase the leakage Because the thermodynamic equilibrium is influenced by decreasing or increasing the pressure when changing to the next pressure step, wait at least 60 s before reading the values. Carry out the measurement in at least five pressure steps (e.g. 50 mmhg, 100 mmhg, 150 mmhg, 200 mmhg and 250 mmhg) over the whole measuring range. Test the air leakage over a period of five min (8.4.1c)), and determine the measured value from this Expression of results Express the air leakage as the pressure reduction per minute. 14

15 8.5 Test method for the pressure reduction rate Apparatus a) T-piece; b) Calibrated reference manometer with signal output port and an error less than 0,8 mmhg (0,1 kpa); c) Artificial limbs or human subjects; NOTE Two limb sizes should be used, equal to the extent of the range of limb circumferences for which the particular size of cuff is recommended. d) Recording unit Procedure Measure the pressure reduction rate either on the limbs of the human subjects or on artificial limbs (8.5.1c)). NOTE It is intended that the characteristics of the artificial limb reflects the elastic characteristics of a human limb. Because cuff deflation rate may be influenced by the way that a cuff is applied, apply and remove the cuff for each of at least ten repeated measurements on at least two different limb sizes. These two limb sizes should be equal to the upper and lower limits of limb circumferences with which a particular size of cuff is recommended for use. The deflation may be re-set. Connect the calibrated reference manometer (8.5.1b)) to the cuff by means of a T-piece (8.5.1a)). Connect the output port of the calibrated reference manometer to the recording unit (8.5.1d)) Expression of results Determine the rate of pressure reduction (e.g. by graphical evaluation and drawing tangents) at the pressure values 60 mmhg, 120 mmhg and 180 mmhg. Calculate the pressure reduction rate as the mean value calculated separately for the pressure values 60 mmhg, 120 mmhg and 180 mmhg and for the various limb circumferences. If the pressure reduction rates are dependent on the pulse, record the pulse rate. In this case, express the result as pressure reduction rate per pulse. 8.6 Test method for the rapid exhaust valve Apparatus a) Two rigid vessels with volumes of 100 ml ± 5 % and 500 ml ± 5 % respectively; b) Calibrated reference manometer with an error less than 0,8 mmhg (0,1 kpa); c) T-piece; d) Stopwatch Procedure Carry out the test with a 500 ml metal vessel (8.6.1.a)) in place of the cuff. For blood pressure measuring systems having the capability of measuring in a neonatal/infant mode or for measuring at the wrist, carry out the test with a 100 ml metal vessel (8.6.1a)) in place of the cuff. 15

16 Connect the calibrated reference manometer (8.6.1b) by means of a T-piece (8.6.1c)) to the pneumatic system. Inflate at least to the maximum pressure given in 7.4.3, wait 60 s and activate the rapid exhaust valve. Measure the time between the pressure values specified in using a stopwatch (8.6.1d)) Expression of results Express the results as the measured exhaust times. 8.7 Test method for the zero setting Apparatus a) Rigid vessel with a volume of 500 ml ± 5 %; b) Calibrated reference manometer with an error less than 0,8 mmhg (0,1 kpa); c) Electro-mechanical pressure/suction pump; d) Pressure generator, e.g. ball pump (hand pump) with pressure release valve; e) T-pieces; f) Hoses Procedure and evaluation If, because of technical reasons, the test as described in 8.7.2, cannot be performed, use an alternative test procedure specified by the manufacturer To test the function of the zero setting, apply a pressure of + 6 mmhg (+ 0,8 kpa) and subsequently -6 mmhg (-0,8 kpa) to the pneumatic circuit and initiate a zero setting of the device. Ensure that all displayed pressure values have a systematic error of -6 mmhg (-0,8 kpa) and + 6 mmhg (+ 0,8 kpa) respectively. Before beginning the test, allow the blood pressure measuring system to reach working temperature Set up the blood pressure measuring system to be tested as follows: Replace the cuff with a 500 ml vessel (8.7.1a) Insert a calibrated reference manometer (8.7.1b)) into the pneumatic circuit by means of a T-piece (8.7.1e)) Insert a pressure/suction pump (8.7.1c)) into the pneumatic circuit by means of a T-piece; Insert a pressure generator (8.7.1d)) into the pneumatic circuit by means of a T-piece. NOTE If convenient, one adjustable pump may be used in place of the pressure/suction pump (8.7.1c)) and pressure generator (8.7.1d)) to generate the pressures in

17 Proceed in the following way: a) Initiate a zero setting as described by the manufacturer. Set the blood pressure measuring system in the service mode, if available. Raise the pressure to 100 mmhg (13,0 kpa) immediately afterwards and record the displayed value; b) Generate a constant gauge pressure of + 6 mmhg (+ 0,8 kpa) in the pneumatic circuit by using the pressure/suction pump at the moment of zero setting. During this period close the deflation valve of the device under test or close the hose (8.7.1f)) to it, e.g. by pinching the hose tightly. Set the blood pressure measuring system in the service mode, if available. Raise the pressure to 100 mmhg (13,0 kpa) immediately afterwards. The zero setting is operating correctly if the displayed value decreases by 6 mmhg (0,8 kpa) compared to the value taken in a); c) Repeat b) with a constant gauge pressure of - 6 mmhg (-0,8 kpa) in the pneumatic circuit. Set the blood pressure measuring system in the service mode, if available. Raise the pressure to 100 mmhg (13,0 kpa) immediately afterwards. The zero setting is operating correctly if the displayed value increases by 6 mmhg (0,8 kpa) compared to the value taken in a). 8.8 Test method for the drift of the cuff pressure indication General This test applies to devices performing zero setting only immediately after switching on Apparatus a) Rigid vessel with a volume of 500 ml ± 5 %; b) Calibrated reference manometer with an error less than 0,8 mmhg (0,1 kpa); c) Stopwatch; d) T-pieces; e) Patient simulator as described in c) Procedure and evaluation Replace the cuff with a 500 ml vessel (8.8.2a)). Insert a calibrated reference manometer (8.8.2b)) and the patient simulator (8.8.2e)) into the pneumatic circuit by means of a T-piece (8.8.2d)). Before beginning the test, allow the blood pressure measuring system to reach operating temperature as described in the instructions for use. Test the stability of the cuff pressure indication after the zero setting at a pressure value of 50 mmhg (7,0 kpa) according to the procedure specified in 8.1.2a) of EN :1995. Under the same environmental conditions determine the time (t 1 ) until the change of the cuff pressure indication exceeds 1 mmhg (0,1 kpa). Switch off the device and switch on afterwards. Perform one blood pressure measurement and wait until the device has switched off automatically. Determine the time (t 2 ) between switching on and automatically switching off. The time (t 2 ) shall be less or equal to the time (t 1 ). 8.9 Test method for the stability of the blood pressure determination Apparatus a) Patient simulator as described in c); 17

18 b) Climatic chamber, capable of adjustment to an accuracy of 1 C for the temperature and 5 % for the relative humidity Procedure Carry out the testing of the signal processing by means of a patient simulator (8.9.1a)). For each of the following combinations of temperature and humidity, place the blood pressure measuring system for at least 3 h in the climatic chamber (8.9.1b)) to allow the system to reach steady conditions: a) 10 C ambient temperature, 85 % Relative Humidity (non-condensing); b) 20 C ambient temperature, 85 % Relative Humidity (non-condensing); c) 40 C ambient temperature, 85 % Relative Humidity (non-condensing); For each combination of temperature and humidity, take 20 consecutive readings by the tested blood pressure measuring system. Place the blood pressure measuring system in the climatic chamber for at least 3 h. At each combination of temperature and humidity switch on the blood pressure measuring system before starting the test. Wait until the warm up time (described in the instructions for use) has elapsed, carry out the measurement (20 consecutive readings) and switch off the blood pressure measuring system afterwards Expression of results Determine the mean value (systolic and diastolic values separately) of the 20 consecutive readings taken at each combination of temperature and humidity. NOTE Because the testing of the influence of temperature and humidity for the signal processing cannot be separated from the temperature/humidity effect on the pressure transducer and the deviations originating from the simulator, both contributions should be taken into account for the evaluation of the test Test method for the stability of cuff pressure indication following prolonged usage Procedure Carry out the test according to the procedure specified in 8.1 of EN :1995 prior to prolonged usage. Perform simulated measurement cycles with the complete blood pressure measurement system at which at least the following cuff pressure values shall be reached: a) Adult mode: 150 mmhg (20,0 kpa); b) Neonatal mode: 75 mmhg (10,0 kpa). NOTE 1 For devices which measure with the auscultatory and oscillometric method this test should be caried out only for one method. NOTE 2 mode. For devices which measure with both modes (adult/neonatal) the test should be carried out only for the adult Expression of results Express the result as the difference between the cuff pressure indication before and after simulated blood pressure measurement cycles at the same test pressure and under the same environmental conditions. 18

19 8.11 Test method for the effect of external voltages and abnormal connections to the signal input/output part Apparatus a) Rigid vessel with a volume of 500 ml ± 5 %; b) Calibrated reference manometer with an error less than 0,8 mmhg (0,1 kpa); c) T-piece; d) Pressure generator, e.g. ball pump (hand pump) with pressure release valve Procedure a) Replace the cuff with a 500 ml vessel (8.11.1a)); b) Insert a calibrated reference manometer (8.11.1b)) into the pneumatic circuit by means of a T-piece (8.11.1c)). Raise the pressure to 100 mmhg (13,0 kpa) and record the displayed value. c) Repeat b) during short circuit of all contacts of the signal input/output part of the non-invasive measuring system one with another; d) Repeat b) during loading each contact belonging to the non-invasive blood pressure measuring system with the maximum voltage specified by the manufacturer (see clause 9.2) Evaluation Compare the indicated value at b) with the indicated value at c) and d) Test method for the cuff pressure deflation following an aborted measurement Apparatus a) Calibrated reference manometer with an error less than 0,8 mmhg (0,1 kpa); b) T-piece Procedure and evaluation Insert a calibrated reference manometer (8.12.1a)) into the pneumatic circuit by means of a T-piece (8.12.1b)). Start a blood pressure measurement. Abort the measurement during inflation. Start another measurement and abort it during the pressure reduction. If interval measurements are possible repeat the test in this mode. Check by visual inspection if the rapid exhaust (7.4.3) is activated. 9 Information supplied by the manufacturer 9.1 General 9.1 of EN :1995 shall apply. 19

20 9.2 Instructions for use #9.2 of EN shall apply with the following addition:$ a) Nature and frequency of the maintenance to ensure that the device operates properly and safely at all times; NOTE It is recommended that the performance should be checked every 2 years and after maintenance and repair, by retesting at least the requirements in 7.2 and (testing at least at 50 mmhg and 200 mmhg). b) A list of all components belonging to the pressure measuring system, including accessories; c) A description of the operating principles of the blood pressure measuring device; d) Remarks on the environmental or operation factors which may affect the performance (e.g. electromagnetic fields, arrhythmia); e) Specification of the signal input/output part; f) Specification of the rated voltage, if applicable; g) Specification of the intended power source, if applicable; h) Nominal range for the result of the blood pressure measurement; i) Warm-up time, if applicable; j) A description of the meaning "out of range-signal" (see 7.3.2c)), if applicable; k) A description of the alarms, if applicable. 9.3 Marking of devices 9.3 of EN :1995 shall apply. 20

21 !deleted text" 21

22 Annex A (informative) Bibliography [1] BIPM/IEC/ISO/OIML, "International vocabulary of basic and general terms of metrology" 22

23 Annex ZA (informative) #Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. 23

24 Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes ,2,3, , , , , ,2,3, , , 10,1 24

25 Table ZA.1 (continued) Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes , ,13.4, , 13.3 a), b), d), e), f), i), j), k), l), 13.6 a), b), c), d), f), h), i), k), l), m), n), o), p), q) 9.2 1, dash 1, 9.1, 12.9, 13.3 a), 13.6 a), b), c), d), f), h), i), k), l), m), n), o), p) The requirement 13.6 q) is addressed by the amended 9.1 of EN The requirement concerning use error is addressed by 9.2 c) of EN The requirement 13.3 a) is addressed by the amended 9.2 e) of EN a), b), d), e), f), i), J) k), l) The requirement 13.3 a) is addressed by the amended 9.3 of EN Annex A 10.1, 14 6a This requirement is not addressed in this European Standard 7.1, Dash 3 This requirement is not addressed in this European Standard 7.4 This requirement is not addressed in this European Standard 7.5 This requirement is not addressed in this European Standard 12.1a This requirement is not addressed in this European Standard 13.3 f) This requirement is not addressed in this European Standard 13.6 h) 2 nd para This requirement is not addressed in this European Standard WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.$ 25