INTERNATIONAL OIML R 89 OIML R 89 RECOMMENDATION Edition 1990 (E) Electroencephalographs -...

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Transcript of INTERNATIONAL OIML R 89 OIML R 89 RECOMMENDATION Edition 1990 (E) Electroencephalographs -...

  • INTERNATIONAL OIML R 89RECOMMENDATION Edition 1990 (E)

    Electroencephalographs - Metrological characteristics -Methods and equipment for verification

    Electroencphalographes - Caractristiques mtrologiques - Mthodes et moyensde vrification

    ORGANISATION INTERNATIONALEDE MTROLOGIE LGALE

    INTERNATIONAL ORGANIZATIONOF LEGAL METROLOGY

    OIM

    L R

    89

    Editi

    on 1

    990

    (E)

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    Foreword

    The International Organization of Legal Metrology(OIML) is a worldwide, intergovernmentalorganization whose primary aim is to harmonize theregulations and metrological controls applied by thenational metrological services, or relatedorganizations, of its Member States.

    The two main categories of OIML publications are:

    International Recommendations (OIML R),which are model regulations that establish themetrological characteristics required of certainmeasuring instruments and which specifymethods and equipment for checking theirconformity; the OIML Member States shallimplement these Recommendations to thegreatest possible extent;

    International Documents (OIML D), which areinformative in nature and intended to improvethe work of the metrological services.

    OIML Draft Recommendations and Documents aredeveloped by technical committees orsubcommittees which are formed by the MemberStates. Certain international and regional institutionsalso participate on a consultation basis.

    Cooperative agreements are established between OIMLand certain institutions, such as ISO and IEC, with theobjective of avoiding contradictory requirements;consequently, manufacturers and users of measuringinstruments, test laboratories, etc. may applysimultaneously OIML publications and those of otherinstitutions.

    International Recommendations and InternationalDocuments are published in French (F) and English (E)and are subject to periodic revision.

    This publication reference OIML R 89 (E), edition1990 which is under the responsibility of TC 18/SC 4Bio-electrical instruments, was sanctionned by theInternational Conference of Legal Metrology in 1988.

    OIML publications may be obtained from theOrganizations headquarters:

    Bureau International de Mtrologie Lgale11, rue Turgot - 75009 Paris - FranceTelephone: 33 (0)1 48 78 12 82 and 42 85 27 11Fax: 33 (0)1 42 82 17 27E-mail: biml@oiml.orgInternet: www.oiml.org

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    ELECTROENCEPHALOGRAPHS

    METROLOGICAL CHARACTERISTICS

    METHODS and EQUIPMENT for VERIFICATION

    1. Scope

    1.1. This Recommendation concerns analogue electroencephalographs, which are defined as diagnosticmedical instruments having at least eight channels. Such instruments are intended to accuratelymeasure and record bioelectrical potentials and their time sequences as detected by electrodesattached to the surface of the human scalp.

    1.2. This Recommendation does not apply to information-processing electroencephalographs, norinstruments that digitize the signals, nor other special-purpose instruments.

    1.3. This Recommendation is intended for the use of metrological services and other responsiblegovernmental agencies. It specifies the metrological characteristics to be determined, methods of andequipment for testing, and initial and subsequent verifications of electroencephalographs that areregulated by laws. Metrological characteristics include errors in measuring voltage signals and timeintervals as well as a number of other characteristics that affect measurement accuracy. Proceduresare given for determining the relative error of measurement of sixteen instrument characteristics, andformulae are provided for calculating the associated permitted limits of these characteristics. Thesetesting and control procedures provide a basis for ensuring that electroencephalographs of adequateaccuracy are available for clinical measurements. The characteristics of the instrument covered arethose that have been deemed to be important in order to achieve the necessary measurement accuracyin clinical practice; therefore, any changes in the requirements prescribed should be based on clinicalexperience and the needs of electroencephalography.

    1.4. This Recommendation does not address pattern approval, terminology, technical requirements,electrical safety and the associated test methods. Some of these matters are being considered by theInternational Electrotechnical Commission (IEC) in the (draft) Publication 601-2-xx "Medicalelectrical equipment Part 2: Particular requirements for the safety of electroencephalographs"under the auspices of SC 62D on "Electromedical equipment". A subject that is also underconsideration by SC 62D is " Particular requirements for the performance of electroencephalographs".The requirements of this Recommendation are also compatible with "Recommended specificationsfor electroencephalographs" developed by the International Federation of Societies forElectroencephalography and Clinical Neurophysiology (IFSECN). Those specifications can be foundin "Recommendations for the Practice of Clinical Neurophysiology", IFSECN, Elsevier, Amsterdam-New York-Oxford (1983).

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    2. Characteristics to be verified

    The characteristics shown in Table 1 should be measured during verification of electroencephalographs.

    Table 1

    Metrological characteristics to be verified.

    Metrological characteristics PointVerified during

    Initial Subsequentverification

    Relative voltage-measurement error 5.3.1 + +

    Relative sensitivity-setting error 5.3.2 +

    Relative time-interval measurement error 5.3.3 + +

    Relative error of the recording speed 5.3.4 +

    Recording hysterisis 5.3.5 +

    Relative errors of internal calibrator and timemarker

    5.3.6 + +

    Overshoot 5.3.7 +

    Time constant 5.3.8 +

    Amplitude-frequency response curve 5.3.9 + +

    Input impedance 5.3.10 +

    Common-mode rejection ratio 5.3.11 + +

    Baseline width 5.3.12 +

    Baseline drift 5.3.13 + +

    Intrinsic noise level referred to the input 5.3.14 + +

    Interchannel crosstalk coefficient 5.3.15 +

    Relative error of the interelectrode-resistancemeasurement

    5.3.16 +

    Verification of current in the patient circuit is also required at initial verification (see point 5.4).

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    3. Measuring instruments used for verification

    The measuring instruments listed in Table 2 are recommended for the verification ofelectroencephalographs.

    Table 2Measuring instruments used for verification

    Measuring instrument Symbol Main characteristics

    Sine-wave signal generator (*) G1 Frequency range 0.01 Hz 100 HzMax.frequency error 1 %Voltage range 10 mV 10 V RMSMax. voltage error 1 %Double-ended output

    Square-wave signal generator (*) G2 Frequency range 0.01 Hz 1 000 HzMax. frequency error 1 %Voltage range 1 mV 10 VMax. voltage error 0.5 %Double-ended output

    Voltage divider (**) D1 Division factor 10 000 (R1 = 100 k;R2 = 10 ; max.error 1 %)Max.error of division 2 %

    Simulated skin-electrodeimpedance (***)

    Z1 R3 = 4.7 k 1 %

    DC voltage source U1 Voltage 1.5 V 5 %Length-measuring device Measurement length 1 mm 100 mm

    Max.error 0.1 mm on measuring length from 0 mm to 10 mm,and 1 % on measuring length from 10 mm to 100 mm.

    Magnifying glass Magnification 5Resistors R4-R12 R4 = 200 ; R5 = 50 ; R6 = 100 k ;

    R7 = 620 k , R8 = 5 k , R9 = 1 k ;R10 = 5 k; R11 = 20 k ; R12 = 50 kMax. error 1 %

    Capacitors C1, C2 C1 = 0.5 F; C2 = 4.7 nFMax.error 5 %

    Impedance Z2 R7 in parallel with C2

    (*) If the voltage or frequency of generator G1 or G2 do not meet the specifications of Table 2, a voltmeter and afrequency meter with the accuracy specified for the generator output voltage and frequency should be provided.(**) See Figure 1.(***) Impedance Z1 (called in the text "patient skin-electrode impedance" is intended to simulate the electricalcharacteristics of the electrode-skin interface.

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    4. Verification conditions and preparation for verification

    4.1. The recommended conditions for verification are as follows: ambient temperature: 15 C to 25 C, atmospheric pressure: 96 kPa to 104 kPa, relative humidity of air: 50 % to 80 % (no condensation), mains voltage fluctuations: 2 % of nominal voltage, mains frequency: (60 Hz or 50 Hz) 2 %.

    The ranges of atmospheric conditions may be extended for regions with extreme temperatures(or other climatic conditions) or high altitude.

    4.2. Deviations of the power-supply voltage should not exceed the values indicated in themanufacturer's manual.

    4.3. Before the electroencephalographs are verified, they and the measuring instruments required forverification should be assembled according to the requirements of the national metrology service orother officially authorized organizations. Measuring instruments used during verification should bechecked by authorized personnel.

    5. Verification

    5.1. External examination

    External examination includes a check that the manufacturer's manual, which should provide thenecessary information on the electroencephalograph, is available and includes the following: values of commonly accepted characteristics, their tolerance limits and procedures for their

    determination, diagrams and construction details necessary for carrying out verification procedures, operating and maintenance instructions, instructions for special medical applications.

    External examination includes checks for: absence of corrosion and mechanical damage, and freedom from any trace of deterioration of the lead cables.

    5.2. Testing

    The electroencephalograph shall be tested after the warm-up period specified b