EN ISO 81060-2:2014

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung von Geräten der automatisierten Bauart (ISO 81060-2:2013)Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type à mesurage automatique (ISO 81060-2:2013)Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN ISO 81060-2:2014SIST EN ISO 81060-2:2014en01-september-2014SIST EN ISO 81060-2:2014SLOVENSKI
STANDARDSIST EN 1060-4:20051DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 81060-2
April 2014 ICS 11.040.10 Supersedes EN 1060-4:2004English Version
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)
Sphygmomanomètres non invasifs - Partie 2: Validation clinique pour type à mesurage automatique (ISO 81060-2:2013)
Nichtinvasive Blutdruckmessgeräte - Teil 2: Klinische Prüfung von Geräten der automatisierten Bauart (ISO 81060-2:2013) This European Standard was approved by CEN on 18 April 2014.
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-CENELEC 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-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 81060-2:2014 ESIST EN ISO 81060-2:2014

Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .4
(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. Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 to 6 10.1 Only the characteristics of the measurement performance (accuracy), as well as the corresponding tests methods, are addressed. 5.1.6, 5.2.2, 6.2.1, 6.2.2, 6.2.7, 7 13.6 Only additional warnings and precautions specific to particular situations and subjects populations are addressed. 4.2 Annex X, 2.2 Normative reference to EN ISO 14155 in its entirety. 5 to 7 Annex X, 2.3.1 to 2.3.3
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 81060-2:2013(E)© ISO 2013
INTERNATIONAL STANDARD ISO81060-2Second edition2013-05-01Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type Sphygmomanomètres non invasifs — Partie 2: Validation clinique pour type à mesurage automatique
ISO 81060-2:2013(E)
©
ISO 2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56  CH-1211 Geneva 20 Tel.
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ii © ISO 2013 – All rights reserved
ISO 81060-2:2013(E) © ISO 2013 – All rights reserved
iii Contents Page 1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 2 4 General requirements for CLINICAL INVESTIGATIONS . 2 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER . 3 6 CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT . 17 7 * Pregnant (including pre-eclamptic) PATIENT populations . 22 Annex A (informative)
Rationale and guidance . 23 Annex B (normative)
Target heart rates for exercise stress testing . 35 Annex C (informative)
Reference to the essential principles . 36
ISO 81060-2:2013(E) iv
 terms defined in this document: SMALL CAPITALS TYPE. Throughout this document, text for which a rationale is provided in Annex A is indicated by an asterisk (*). The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of ISO/TC 121 and IEC/TC 62 that the content of this part of ISO 81060 not be adopted for mandatory implementation nationally earlier than 3 years from the date of publication for equipment newly designed, and not earlier than 5 years from the date of publication for equipment already in production. SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved
v Introduction Determination of BLOOD PRESSURE is an important procedure that is clinically used to assess the status of a PATIENT. Frequent determination of BLOOD PRESSURE is routine during anaesthesia. BLOOD PRESSURE serves to aid in drug titration and fluid management and to provide warning of conditions that could affect PATIENT morbidity and mortality.
INTERNATIONAL STANDARD ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 1 Non-invasive sphygmomanometers — Part 2: Clinical investigation of the automated measurement type 1 Scope This part of ISO 81060 specifies the requirements and methods for the CLINICAL INVESTIGATION of ME EQUIPMENT used for the intermittent non-invasive automated estimation of the arterial BLOOD PRESSURE by utilizing a CUFF. This part of ISO 81060 is applicable to all SPHYGMOMANOMETERS that sense or display pulsations, flow or sounds for the estimation, display or recording of BLOOD PRESSURE. These SPHYGMOMANOMETERS need not have automatic CUFF inflation.
This part of ISO 81060 covers SPHYGMOMANOMETERS intended for use in all PATIENT populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring, stress testing BLOOD PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT for self-measurement as well as use in a professional healthcare facility). EXAMPLE AUTOMATED SPHYGMOMANOMETER as given in IEC 80601-2-30 undergoing CLINICAL INVESTIGATION according to this part of ISO 81060. This part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060. This part of ISO 81060 is not applicable to CLINICAL INVESTIGATIONS of NON-AUTOMATED SPHYGMOMANOMETERS as given in ISO 81060-1 or INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as given in IEC 60601-2-34. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice ISO 81060-1, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type IEC 80601-2-30:2009, Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance Amendment 1:2012 SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) 2 © ISO 2013 – All rights reserved IEC 60601-1-11:2010, Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home care applications IEC 60601-2-34:2011, Medical electrical equipment — Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14155, IEC 80601-2-30, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-34 and the following apply.
NOTE For convenience, an alphabetized index of defined terms is found beginning on page 40. 3.1 REFERENCE, adj established accuracy used for the CLINICAL INVESTIGATION of other instruments 3.2 SPHYGMOMANOMETER ME EQUIPMENT for non-invasive estimation of systemic arterial BLOOD PRESSURE 3.3 SPHYGMOMANOMETER-UNDER-TEST SPHYGMOMANOMETER undergoing CLINICAL INVESTIGATION 4 General requirements for CLINICAL INVESTIGATIONS 4.1 CLINICAL INVESTIGATION methods SPHYGMOMANOMETERS other than NON-AUTOMATED SPHYGMOMANOMETERS shall undergo CLINICAL INVESTIGATION either by using a non-invasive (auscultatory) REFERENCE SPHYGMOMANOMETER or by using REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT according to this part of ISO 81060 in each mode of operation. EXAMPLE 1 Adult and neonatal modes. EXAMPLE 2 Slow and fast CUFF deflation rate modes. A CLINICAL INVESTIGATION shall be considered a TYPE TEST. Consider compliance with the requirements of this subclause to exist when the criteria of the relevant inspections and tests in this part of ISO 81060 are met. 4.2 Good clinical practice All CLINICAL INVESTIGATIONS shall comply with the requirements of ISO 14155. CLINICAL INVESTIGATION with REFERENCE INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT should not be used for PATIENTS or subjects solely for the purpose of investigating SPHYGMOMANOMETER performance. NOTE Some authorities having jurisdiction have additional requirements. The requirements of this International Standard, which are more specific than the corresponding requirements of ISO 14155, shall prevail.
Check compliance by application of the requirements of ISO 14155. SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 3 5 CLINICAL INVESTIGATION with an auscultatory REFERENCE SPHYGMOMANOMETER 5.1 Subject requirements 5.1.1 * Number An auscultatory REFERENCE SPHYGMOMANOMETER CLINICAL INVESTIGATION shall consist of a minimum of 85 subjects. If not otherwise specified, at least three valid BLOOD PRESSURE DETERMINATIONS shall be taken for each subject. There shall be a minimum of 255 valid paired BLOOD PRESSURE DETERMINATIONS. Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.2 * Gender distribution At least 30 % of the subjects shall be male and at least 30 % of the subjects shall be female. Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.3 * Age distribution For a SPHYGMOMANOMETER intended for use on adults and/or adolescent PATIENTS, the age of every subject included in the CLINICAL INVESTIGATION shall be greater than 12 years. NOTE 1 Minimum total of 85 subjects. For a SPHYGMOMANOMETER additionally intended for use in children, 35 child subjects aged between 3 years and 12 years shall be included in the CLINICAL INVESTIGATION. NOTE 2 Minimum total of 85 subjects. If the SPHYGMOMANOMETER has a special mode for children, in that mode, children shall be considered a special PATIENT population (see 5.1.6). In such a study, children are exempt from the BLOOD PRESSURE distribution requirements of 5.1.5. Children aged less than 3 years shall not be included in a CLINICAL INVESTIGATION utilizing auscultatory DETERMINATIONS by observers with a REFERENCE SPHYGMOMANOMETER. Check compliance by inspection of the ACCOMPANYING DOCUMENT and the CLINICAL INVESTIGATION REPORT. 5.1.4 * Limb size distribution For a SPHYGMOMANOMETER intended for use with a single CUFF size:  at least 40 % of the subjects shall have a limb circumference which lies within the upper half of the specified range of use of the CUFF and at least 40 % shall have a limb circumference within the lower half; and  at least 20 % of the subjects shall have a limb circumference which lies within the upper quarter of the specified range of use of the CUFF and at least 20 % shall have a limb circumference within the lower quarter. For a SPHYGMOMANOMETER intended for use with multiple CUFF sizes, each CUFF size shall be tested on at least 12n of the subjects, where nis the number of CUFF sizes. Check compliance by inspection of the ACCOMPANYING DOCUMENT and the CLINICAL INVESTIGATION REPORT. SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) 4 © ISO 2013 – All rights reserved 5.1.5 * BLOOD PRESSURE distribution At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≤ 100 mmHg (13,33 kPa). At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≥ 160 mmHg (21,33 kPa). At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a SYSTOLIC BLOOD PRESSURE ≥ 140 mmHg (18,66 kPa). At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE ≤ 60 mmHg (8,0 kPa). At least 5 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE ≥ 100 mmHg (13,33 kPa). At least 20 % of the REFERENCE BLOOD PRESSURE readings shall have a DIASTOLIC BLOOD PRESSURE ≥ 85 mmHg (11,33 kPa). Check compliance by inspection of the CLINICAL INVESTIGATION REPORT. 5.1.6 * Special PATIENT populations A SPHYGMOMANOMETER that is intended for use in special PATIENT populations where there is OBJECTIVE EVIDENCE that the accuracy of the SPHYGMOMANOMETER might be problematic in those PATIENT populations, shall undergo CLINICAL INVESTIGATION in those PATIENT populations.
NOTE Clause 7 has a specific example of a special PATIENT population with specific requirements. If the SPHYGMOMANOMETER has undergone CLINICAL INVESTIGATION according to the requirements of 5.1.1 and 5.2, it shall then undergo CLINICAL INVESTIGATION in at least an additional 35 special population subjects. If the SPHYGMOMANOMETER has not previously undergone CLINICAL INVESTIGATION according to the requirements of 5.1.1 and 5.2, the CLINICAL INVESTIGATION in accordance with the requirements of 5.1.1 and 5.2 shall consist only of subjects from the special PATIENT population. The special PATIENT population shall be defined in clear terms and address the following attributes: gender (see 5.1.2), age (see 5.1.3), limb size (see 5.1.4) and BLOOD PRESSURE (see 5.1.5). A summary of this information shall be disclosed in the instructions for use. Check compliance by inspection of the instructions for use and the CLINICAL INVESTIGATION REPORT. 5.2 CLINICAL INVESTIGATION method with a REFERENCE SPHYGMOMANOMETER 5.2.1 * Subject preparation Unless otherwise indicated by the instructions for use of the SPHYGMOMANOMETER-UNDER-TEST, position the subject such that the subject:  is comfortable; EXAMPLE Comfortably seated with legs uncrossed and feet flat on the floor.  has the back, elbow and forearm supported;  has the middle of the CUFF at the level of the right atrium of the heart. SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 5 Recommend that the subject be as relaxed as possible and that the subject avoid talking during the entire procedure. Before the first reading is taken, 5 min should elapse. NOTE Additional details can be found in Reference [32]. 5.2.2 * Observer preparation Observers should be trained in using a proper methodology for performing a resting BLOOD PRESSURE DETERMINATION by utilizing an accepted clinical protocol for BLOOD PRESSURE measurement. References [8], [28], [29], [32] and [45] contain additional information. Observers should have sufficient practice in performing BLOOD PRESSURE DETERMINATIONS. Each observer's recording of observations of the REFERENCE SPHYGMOMANOMETER shall not be visible to the other observer. The readings of the SPHYGMOMANOMETER-UNDER-TEST shall not be visible to either of these observers. EXAMPLE 1 Utilizing a third observer for recording the readings of the SPHYGMOMANOMETER-UNDER-TEST. EXAMPLE 2 Utilizing an electronic means for recording the readings of the SPHYGMOMANOMETER-UNDER-TEST. Instruct the observers to determine the DIASTOLIC BLOOD PRESSURE as the last audible Korotkoff sound (fifth phase or K5), except when Korotkoff sounds are still audible with the CUFF deflated or in children between 3 years and 12 years of age, where the fourth phase (K4) is used. If K4 is not audible in a child, either K5 is used or the subject is excluded. NOTE Other than for children, K4 should be reserved for subjects in whom there is a large discrepancy between muffling and disappearance (with the latter at times approaching zero mmHg). Instruct the observers to record which Korotkoff sound has been used for the DETERMINATION of DIASTOLIC BLOOD PRESSURE. The Korotkoff sound used for DETERMINATION of DIASTOLIC BLOOD PRESSURE in the CLINICAL INVESTIGATION shall be disclosed in the instructions for use of a SPHYGMOMANOMETER. EXAMPLE 3 K5 was used on 65 subjects and K4 was used on 20 subjects. 5.2.3 * REFERENCE DETERMINATION Two observers shall make simultaneous BLOOD PRESSURE DETERMINATIONS on each subject using a double stethoscope. Unless the SPHYGMOMANOMETER-UNDER-TEST is intended for use during significantly irregular heart rhythm and if either observer detects significantly irregular heart rhythm, that DETERMINATION shall be excluded. EXAMPLES Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation. NOTE 1 Although CLINICAL INVESTIGATION of BLOOD PRESSURE in PATIENTS with atrial fibrillation is clinically important, there are currently no generally accepted guidelines for determining the BLOOD PRESSURE in such individuals. Any pair of observers' DETERMINATIONS with a difference greater than 4 mmHg (0,53 kPa) shall be excluded. The observers' individual values of each DETERMINATION shall be averaged according to Formula (1) to create the REFERENCE BLOOD PRESSURE DETERMINATION. ,1,2refrefref2iiippp (1) where ,1refip is the BLOOD PRESSURE determined by observer 1 for the ith DETERMINATION; SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) 6 © ISO 2013 – All rights reserved ,2refip is the BLOOD PRESSURE determined by observer 2 for the ith DETERMINATION; refip is the REFERENCE BLOOD PRESSURE for the ith DETERMINATION. The observer-to-observer differences shall be reviewed after completing a set of pairs of test-REFERENCE DETERMINATIONS. If any DETERMINATIONS are excluded, additional pair(s) of DETERMINATIONS shall be taken to ensure that the required number of valid test-REFERENCE pairs are available. A maximum of eight pairs of DETERMINATIONS should be taken. Use a REFERENCE SPHYGMOMANOMETER that complies with the requirements of ISO 81060-1, except that the maximum permissible error shall be  1 mmHg (0,13 kPa). Reading of the values on the REFERENCE SPHYGMOMANOMETER should be as accurate as possible. When reading the value on the REFERENCE SPHYGMOMANOMETER, the observers should avoid parallax errors and rounding.
NOTE 2 Rounding has a negative effect on the results of the CLINICAL INVESTIGATION. NOTE 3 For the purposes of this part of ISO 81060, the CUFF is considered part of the REFERENCE SPHYGMOMANOMETER. A CUFF that does not comply with ISO 81060-1 cannot be used. 5.2.4 CLINICAL INVESTIGATION methods 5.2.4.1 Same arm simultaneous method 5.2.4.1.1 * Procedure This method shall only be used with a SPHYGMOMANOMETER-UNDER-TEST:  that has a CUFF compliant with ISO 81060-1;  that is designed for use on the upper arm; and  where  the continuous linear deflation rate is between 2 mmHg/s (0,27 kPa/s) and 3 mmHg/s (0,40 kPa/s) or  for a SPHYGMOMANOMETER-UNDER-TEST that controls the deflation as a function of the pulse rate, the deflation rate is between 2 mmHg/pulse (0,27 kPa/pulse) and 3 mmHg/pulse (0,40 kPa/pulse). Either arm may be utilized.
The SPHYGMOMANOMETER-UNDER-TEST shall not deflate prior to the detection of the REFERENCE DIASTOLIC BLOOD PRESSURE. The SPHYGMOMANOMETER-UNDER-TEST may be modified to meet this criterion. NOTE Valid same arm simultaneous DETERMINATIONS require the SPHYGMOMANOMETER-UNDER-TEST to inflate the CUFF to at least 20 mmHg (2,67 kPa) higher than the actual SYSTOLIC BLOOD PRESSURE, as determined by the REFERENCE SPHYGMOMANOMETER, and to at least 20 mmHg (2,67 kPa) below the actual DIASTOLIC BLOOD PRESSURE, as determined by the REFERENCE SPHYGMOMANOMETER. Perform the following: a) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST simultaneously determine the subject's BLOOD PRESSURE utilizing the same CUFF and inflation/deflation cycle (see Figure 1). These data points are not used in the calculation of accuracy of the SPHYGMOMANOMETER-UNDER-TEST. b) Clear the SPHYGMOMANOMETER-UNDER-TEST memory of the previous DETERMINATION and then wait at least 60 s. SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 7 EXAMPLES Switching the power off and on, removing the BLOOD PRESSURE module and reinstalling it or issuing a reset command are methods to clear the memory of the previous DETERMINATION. c) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST simultaneously determine the subject's BLOOD PRESSURE utilizing the same CUFF and inflation/deflation cycle. d) Wait at least 60 s between DETERMINATIONS. e) Repeat c) and d) until the required number of valid DETERMINATIONS has been performed. All data from a subject shall be excluded if any two REFERENCE SYSTOLIC BLOOD PRESSURE DETERMINATIONS differ by more than 12 mmHg (1,60 kPa) or if any two REFERENCE DIASTOLIC BLOOD PRESSURE DETERMINATIONS differ by more than 8 mmHg (1,07 kPa).
Key 1 double stethoscope 2 REFERENCE SPHYGMOMANOMETER display 3 SPHYGMOMANOMETER-UNDER-TEST Figure 1 — Illustration of same arm simultaneous method 5.2.4.1.2 * Data analysis The SPHYGMOMANOMETER-UNDER-TEST shall meet the following two criteria. a) Criterion 1 For SYSTOLIC and DIASTOLIC BLOOD PRESSURES, the mean value of the differences of the DETERMINATIONS, nx, of the nindividual paired DETERMINATIONS of the SPHYGMOMANOMETER-UNDER-TEST and of the observers' DETERMINATIONS with the REFERENCE SPHYGMOMANOMETER for all subjects shall be within or equal to ± 5,0 mmHg (± 0,67 kPa), with a standard deviation, ns, no greater than 8,0 mmHg (1,07 kPa) when calculated according to Formula (2) and Formula (3): sutref11iinnixppn (2) 211 1ninnisxxn (3) SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) 8 © ISO 2013 – All rights reserved where nx is the mean value of the differences; ippsutrefii = x
difference between a paired BLOOD PRESSURE DETERMINATION [DETERMINATION of the SPHYGMOMANOMETER-UNDER-TEST  REFERENCE BLOOD PRESSURE as calculated according to Formula (1)]; i is the index for the individual element; n is the number of DETERMINATIONS; nxand nsshall be calculated and expressed to 0,1 mmHg (0,01 kPa). EXAMPLE 1 = 255 for a SPHYGMOMANOMETER intended for use in adults and/or adolescent PATIENTS (an 85 subject study). nEXAMPLE 2 = 255 for a SPHYGMOMANOMETER intended for use in adults and/or adolescents and children aged between 3 years and12 years (an 85 subject study). nEXAMPLE 3 = 105 for a SPHYGMOMANOMETER intended for a special INTENDED USE (a 35 subject study), when the SPHYGMOMANOMETER has previously undergone CLINICAL INVESTIGATION in a separate 85 subject study according to 5.1.1n and 5.2. b) Criterion 2 For the SYSTOLIC and DIASTOLIC BLOOD PRESSURES for each of the m subjects, the standard deviation, ms, of the averaged paired DETERMINATIONS per subject of the SPHYGMOMANOMETER-UNDER-TEST and of the observers' DETERMINATIONS with the REFERENCE SPHYGMOMANOMETER shall meet the criteria listed in Table 1 or Table 2 when calculated according to Formula (4): 2111njmmjsxxm (4) where nx is the mean value of the differences as calculated according to Formula (2); m is the number of subjects; jx is the index for the individual element; m is calculated according to Formula (5). sutref11()jkkdkxppd (5) where d is the number of DETERMINATIONS per subject;
is the index for the individual element. kSIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 9 EXAMPLE 4 = 85 for a SPHYGMOMANOMETER intended for use in adults and/or adolescent PATIENTS (an 85 subject study). mEXAMPLE 5 = 85 for a SPHYGMOMANOMETER intended for use in adults and/or adolescents and children aged between 3 years and 12 years (an 85 subject study). mEXAMPLE 6 = 35 for a SPHYGMOMANOMETER intended for (an additional) special INTENDED USE (a 35 subject study), when the SPHYGMOMANOMETER has previously undergone CLINICAL INVESTIGATION in a separate 85 subject study according to 5.1.1m and 5.2.
EXAMPLE 7 = 85 for a SPHYGMOMANOMETER intended only for a special INTENDED USE (an 85 subject study). mTable 1 — Averaged subject data acceptance (criterion 2) in mmHg Maximum permissible standard deviation, sm, as function of, nx mmHg nx 0,0 0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8 0,9  0, 6,95 6,95 6,95 6,95 6,93 6,92 6,91 6,90 6,89 6,88  1, 6,87 6,86 6,84 6,82 6,80 6,78 6,76 6,73 6,71 6,68  2, 6,65 6,62 6,58 6,55 6,51 6,47 6,43 6,39 6,34 6,30  3, 6,25 6,20 6,14 6,09 6,03 5,97 5,89 5,83 5,77 5,70  4, 5,64 5,56 5,49 5,41 5,33 5,25 5,16 5,08 5,01 4,90  5, 4,79 § § § § § § § § § EXAMPLE For mean of  4,2 mmHg, the maximum permissible standard deviation is 5,49 mmHg.
Table 2 — Averaged subject data acceptance (criterion 2) in kPa Maximum permissible standard deviation, sm, as function of, nx kPa nx 0,000 0,010 0,020 0,030 0,040 0,050 0,060 0,070 0,080 0,090  0,0 0,9266 0,9266 0,9266 0,9266 0,9266 0,9246 0,9233 0,9223 0,9213 0,9203  0,1 0,9193 0,9183 0,9173 0,9163 0,9152 0,9138 0,9119 0,9099 0,9079 0,9059  0,2 0,9039 0,9007 0,8989 0,8970 0,8946 0,8906 0,8878 0,8855 0,8826 0,8785  0,3 0,8756 0,8723 0,8679 0,8641 0,8601 0,8562 0,8519 0,8471 0,8414 0,8374  0,4 0,8333 0,8283 0,8226 0,8169 0,8119 0,8059 0,7999 0,7933 0,7853 0,7793  0,5 0,7739 0,7669 0,7599 0,7531 0,7463 0,7388 0,7319 0,7237 0,7157 0,7077  0,6 0,6999 0,6891 0,6802 0,6723 0,6670 0,6595 0,6488 0,6386 — — EXAMPLE For mean of  0,520 kPa, the maximum permissible standard deviation is 0,7599 kPa.
5.2.4.2 * Same arm sequential method 5.2.4.2.1 * Procedure Either arm may be utilized.
ISO 81060-2:2013(E) 10 © ISO 2013 – All rights reserved Perform the following: a) Using the REFERENCE SPHYGMOMANOMETER, have the observers determine the subject's BLOOD PRESSURE (see Figure 2). b) Wait at least 60 s. c) Using the SPHYGMOMANOMETER-UNDER-TEST, have the observers determine the subject's BLOOD PRESSURE. d) Clear the SPHYGMOMANOMETER-UNDER-TEST memory of the previous DETERMINATION and then wait at least 60 s. EXAMPLES Switching the power off and on, removing the BLOOD PRESSURE module and reinstalling it or issuing a reset command are methods to clear the memory of the previous DETERMINATION.
Key 1 double stethoscope 2 REFERENCE SPHYGMOMANOMETER display 3 REFERENCE SPHYGMOMANOMETER hand pump 4 SPHYGMOMANOMETER-UNDER-TEST NOTE Only one CUFF is connected to the SPHYGMOMANOMETER-UNDER-TEST. Figure 2 — Illustration of the same arm sequential method e) Do not use the data points obtained in a) and c) in the DETERMINATION of accuracy. f) Using the REFERENCE SPHYGMOMANOMETER, have the observers determine the subject's BLOOD PRESSURE. g) Have the observers use the SPHYGMOMANOMETER-UNDER-TEST and the REFERENCE SPHYGMOMANOMETER to determine the subject's BLOOD PRESSURE sequentially. h) Wait at least 60 s between each DETERMINATION. i) Repeat g) and h) until the required number of valid DETERMINATIONS has been performed. All data from a subject shall be excluded if any two REFERENCE SYSTOLIC BLOOD PRESSURE DETERMINATIONS differ by more than 12 mmHg (1,60 kPa) or if any two REFERENCE DIASTOLIC BLOOD PRESSURE DETERMINATIONS SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 11 differ by more than 8 mmHg (1,07 kPa). Notwithstanding this requirement, if the REFERENCE BLOOD PRESSURE of an individual subject does not meet these criteria during the period of the test, two compliant consecutive DETERMINATION pairs that meet these criteria may be used. In this case, additional subjects shall be used to complete the minimum number of DETERMINATIONS. No more than 10 % of the subjects shall have fewer than three valid DETERMINATION pairs. 5.2.4.2.2 Data analysis
The SPHYGMOMANOMETER-UNDER-TEST shall meet the following two criteria. a) Criterion 1 For SYSTOLIC and DIASTOLIC BLOOD PRESSURES, the mean value of the differences of the DETERMINATIONS, nx, of the nindividual paired DETERMINATIONS of the SPHYGMOMANOMETER-UNDER-TEST and of the observers' DETERMINATIONS with the REFERENCE SPHYGMOMANOMETER for all subjects shall be within or equal to ± 5,0 mmHg (± 0,67 kPa), with a standard deviation,ns, no greater than 8,0 mmHg (1,07 kPa) when calculated according to Formula (6) and Formula (7): sutrefsq11()iinnixppn (6) ninnisxxn2111 (7) where nx is the mean value of the differences; sutrefsqiiippx difference between the ith paired BLOOD PRESSURE DETERMINATIONS (DETERMINATION of the SPHYGMOMANOMETER-UNDER-TEST  REFERENCE BLOOD PRESSURE); i is the index for the individual element; n is the number of DETERMINATIONS; refsqip is the REFERENCE BLOOD PRESSURE for the ith DETERMINATION as calculated according to Formula (8); nxand nsshall be calculated and expressed to at least 0,1 mmHg (0,01 kPa). The REFERENCE BLOOD PRESSURE, , (the observers' DETERMINATIONS with the REFERENCE SPHYGMOMANOMETER) shall be the average of the preceding and following REFERENCE BLOOD PRESSURES.
refsqip,1,21,11,2refsqrefrefrefref1(4iiiippppp)i (8) where ,1refip is the BLOOD PRESSURE determined by observer 1 for the ith DETERMINATION;
,2refip is the BLOOD PRESSURE determined by observer 2 for the ith DETERMINATION. SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) 12 © ISO 2013 – All rights reserved EXAMPLE 1 = 255 for a SPHYGMOMANOMETER intended for use in adults and/or adolescent PATIENTS (an 85 subject study). nEXAMPLE 2 = 255 for a SPHYGMOMANOMETER intended for use in adults and/or adolescents and children aged between 3 years and 12 years (an 85 subject study). nEXAMPLE 3 = 105 for a SPHYGMOMANOMETER intended for a special INTENDED USE (a 35 subject study), when the SPHYGMOMANOMETER has previously undergone CLINICAL INVESTIGATION in a separate 85 subject study according to 5.1.1n and 5.2. b) Criterion 2 For the SYSTOLIC and DIASTOLIC BLOOD PRESSURES for each of the m subjects, the standard deviation, ms, of the averaged paired DETERMINATIONS per subject of the SPHYGMOMANOMETER-UNDER-TEST and of the observers' DETERMINATIONS with the REFERENCE SPHYGMOMANOMETER shall meet the criteria listed in Table 1 or Table 2 when calculated according to Formula (9). 211()1mmjjsxmnx (9) where nx is the mean value of the differences as calculated according to Formula (6); m is the number of subjects; j is the index for the individual element; jx is SPHYGMOMANOMETER-UNDER-TEST error as calculated according to Formula (10); ,,sutrefsq11(jkjkdjkxppd) (10) where d is the number of DETERMINATIONS per subject; k is the index for the individual element; ,refsqjkp
is the REFERENCE BLOOD PRESSURE calculated according to Formula (11). ,,,1,,2,1,1refsqrefrefrefref1(4jkjkjkjkjkppppp,1,2) (11) EXAMPLE 4 = 85 for a SPHYGMOMANOMETER intended for use in adults and/or adolescent PATIENTS (an 85 subject study). mEXAMPLE 5 = 85 for a SPHYGMOMANOMETER intended for use in adults and/or adolescents and children aged between 3 years and 12 years (an 85 subject study). mEXAMPLE 6 = 35 for a SPHYGMOMANOMETER intended for (an additional) special INTENDED USE (a 35 subject study), when the SPHYGMOMANOMETER has previously undergone CLINICAL INVESTIGATION in a separate 85 subject study according to 5.1.1m and 5.2. EXAMPLE 7 = 85 for a SPHYGMOMANOMETER intended only for a special INTENDED USE (an 85 subject study). mSIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 13 5.2.4.3 * Opposite limb simultaneous method 5.2.4.3.1 Procedure The starting arm side of the SPHYGMOMANOMETER-UNDER-TEST and the REFERENCE SPHYGMOMANOMETER DETERMINATIONS shall be alternated between subjects. Perform the following: a) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST simultaneously determine the subject's BLOOD PRESSURE in opposite arms (see Figure 3). b) These data points are not used in the calculation of accuracy. c) Clear the SPHYGMOMANOMETER-UNDER-TEST memory of the previous DETERMINATION and wait at least 60 s. EXAMPLES Switching the power off and on, removing the BLOOD PRESSURE module and reinstalling it or issuing a reset command are methods to clear the memory of the previous DETERMINATION. d) Interchange arm sides of the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST. e) Wait at least 60 s from the completion of the previous determination. f) Have the observers using the REFERENCE SPHYGMOMANOMETER and the SPHYGMOMANOMETER-UNDER-TEST simultaneously determine the subject's BLOOD PRESSURE in opposite arms.
g) Repeat d) to f) until six paired determinations have been performed. h) If the DETERMINATION by the observers with the REFERENCE SPHYGMOMANOMETER or the SPHYGMOMANOMETER-UNDER-TEST is not successfully completed, repeat the DETERMINATION on the same arm (i.e. without interchanging sides). i) Repeat a) to h) until the required number of valid subjects and DETERMINATIONS has undergone CLINICAL INVESTIGATION. All data from a subject shall be excluded if  any two REFERENCE SYSTOLIC BLOOD PRESSURE DETERMINATIONS on the same arm differ by more than 12 mmHg (1,60 kPa) or any two REFERENCE DIASTOLIC BLOOD PRESSURE DETERMINATIONS on the same arm differ by more than 8 mmHg (1,07 kPa).  the lateral difference of the REFERENCE SYSTOLIC BLOOD PRESSURE DETERMINATIONS is more than 15 mmHg (2,00 kPa) or the lateral difference of the REFERENCE DIASTOLIC BLOOD PRESSURE DETERMINATIONS is more than 10 mmHg (1,33 kPa). SIST EN ISO 81060-2:2014

ISO 81060-2:2013(E) 14 © ISO 2013 – All rights reserved
Key 1 double stethoscope 2 REFERENCE SPHYGMOMANOMETER display 3 REFERENCE SPHYGMOMANOMETER hand pump 4 SPHYGMOMANOMETER-UNDER-TEST NOTE Only one CUFF is connected to the SPHYGMOMANOMETER-UNDER-TEST. Figure 3 — Illustration of opposite arm simultaneous method The lateral difference, LD, is calculated separately for SYSTOLIC and DIASTOLIC BLOOD PRESSURES, according to Formula (12). 33ref_Rref_L1113ijijLDpp
(12) where ref_Ripand ref_Ljpare REFERENCE BLOOD PRESSURES in the right (R) arm and left (L) arm, respectively. 5.2.4.3.2 * Data analysis The SPHYGMOMANOMETER-UNDER-TEST error, x, is calculated by taking the difference between the SPHYGMOMANOMETER-UNDER-TEST BLOOD PRESSURE and the REFERENCE SPHYGMOMANOMETER BLOOD PRESSURE and by adding the lateral difference, LD, as calculated according to Formula (13) if the SPHYGMOMANOMETER-UNDER-TEST BLOOD PRESSURE was taken in the left arm or by subtracting the lateral difference, LD, as calculated according to Formula (14) if the SPHYGMOMANOMETER-UNDER-TEST BLOOD PRESSURE was taken in the right arm. sut_Lref_RxppLD
(13) SIST EN ISO 81060-2:2014
ISO 81060-2:2013(E) © ISO 2013 – All rights reserved 15 sut_Rref_LxppLD (14) where and sut_Rpsut_Lpare SPHYGMOMANOMETER-UNDER-TEST BLOOD PRESSURES in right (R) arm and left (L) arm, respectively. The SPHYGMOMANOMETER-UNDER-TEST shall meet the following two criteria. a) Criterion 1 For SYSTOLIC and DIASTOLIC BLOOD PRESSURES, the mean value of the differences of the DETERMINATIONS, ,nx of the n individual paired DETERMINATIONS of the SPHYGMOMANOMETER-UNDER-TEST and of the observers' DETERMINATIONS with the REFERENCE SPHYGMOMANOMETER for all subjects shall be within or equal to ± 5,0 mmHg (± 0,67 kPa), with a standard deviation, sn, not greater than 8,0 mmHg (1,07 kPa) when calculated according to Formula (15) and Formula (16). 11nniixxn (15) 2111nniisxnnx (16) where
ix is the SPHYGMOMANOMETER-UNDER-TEST error as calculated according to Formula (13) and Formula (14); n is the number of DETERMINATIONS; i is the index for the individual element. EXAMPLE 1 = 510 for a SPHYGMOMANOMETER intended for use in adults and/or adolescent PATIENTS (an 85 subject study). nEXAMPLE 2 = 510 for a SPHYGMOMANOMETER intended for use in adults and/or adolescents and children aged between 3 years and 12 years (an 85 subject study). nEXAMPLE 3 = 210 for a SPHYGMOMANOMETER intended for (an additional) special INTENDED USE (a 35 subject study), when the SPHYGMOMANOMETER has previously undergone CLINICAL INVESTIGATION in a separate 85 subject study according to 5.1.1n and 5.2. b) Criterion 2 Fo
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