prEN ISO 81060-2

• Abstract:

  This document 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 document 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 document 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 document.; This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.; This document 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.; This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.

• Status: Not Published
• Publication Date: 12-Dec-2027
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 14-Sep-2026
• Completion Date: 14-Sep-2026
• Ref Project: oSIST prEN ISO 81060-2:2026 - Non-invasive sphygmomanometers - Part 2: Clinical performance verification of intermittent automated measurement type (ISO/DIS 81060-2:2026)

• Revises: EN ISO 81060-2:2019/A1:2020 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 1 (ISO 81060-2:2018/Amd 1:2020)
• Effective Date: 09-Jun-2024
• Revises: EN ISO 81060-2:2019/A2:2024 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
• Effective Date: 09-Jun-2024
• Revises: EN ISO 81060-2:2019 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
• Effective Date: 09-Jun-2024

prEN ISO 81060-2 is a CEN draft for non-invasive sphygmomanometers. It specifies how to verify the clinical performance of intermittent automated blood pressure measurement types that use a cuff, and what accompanying information must disclose after a successful clinical investigation.

What does prEN ISO 81060-2 specify?

prEN ISO 81060-2 specifies requirements and methods for the clinical performance verification of ME equipment used for intermittent non-invasive automated estimation of arterial blood pressure by means of a cuff. It applies to sphygmomanometers that sense or display pulsations, flow, or sounds for estimating, displaying, or recording blood pressure, and it does not require automatic cuff inflation.

The document covers use in all patient populations and all conditions of use named in the scope, including ambulatory blood pressure monitoring, stress testing blood pressure monitoring, home healthcare self-measurement, professional healthcare facilities, and emergency medical services. It also adds disclosure requirements for accompanying information when a sphygmomanometer has passed the clinical investigation.

It is not applicable to non-automated sphygmomanometers covered by ISO 81060-1 or to invasive blood pressure monitoring equipment covered by IEC 60601-2-34. A set of cuffs that does not have the same materials and construction must be evaluated separately, so cuff design changes are treated as separate cases in practice.

The document is organized into Clauses 1 to 8, with three informative annexes that add rationale, regulatory mapping, and a term index.

Annex	What it covers
Annex A	Rationale and guidance for selected requirements
Annex B	Mapping to IMDRF essential principles
Annex C	Alphabetized index of defined terms

What are the key requirements of prEN ISO 81060-2?

prEN ISO 81060-2 sets out how to run a clinical investigation, which reference method to use, who can be included, and how results are judged. In practice, the standard tells manufacturers and test teams what to measure, how to compare readings, and what evidence to keep in the report and accompanying information.

Clinical investigation set-up

Clause 4 treats the clinical investigation as a type test, so the verification is based on representative samples rather than routine production checks. Clause 4.1 requires verification in each mode of operation, using either a reference non-invasive auscultatory sphygmomanometer at the upper arm or reference invasive blood pressure monitoring equipment.

Clause 4.2 ties the work to ISO 14155:2026 for good clinical practice, and the document’s specific requirements take priority where they are more detailed. It also requires unique subjects, with each subject used only once in a clinical performance verification. For users, that means the investigation must be planned like a formal clinical study, not an informal bench comparison.

Clause 4.3 says previously successful results according to earlier versions of ISO 81060-2:2018 remain valid, so repeat verification is not needed solely to conform with this document. Clause 4.4 requires the technical description to include contact information so the responsible organization can obtain the summary of the clinical performance verification.

Reference method and subject selection

Clause 5 covers verification with a reference auscultatory sphygmomanometer, while Clause 6 covers verification with reference invasive blood pressure monitoring equipment. Clause 5 requires subject distributions by number, sex, age, limb size, blood pressure, and special patient populations, and it excludes infants under 1 year from auscultatory reference readings.

For auscultatory work, the upper arm measurement rules matter in practice because they control whether the reference cuff can be used reliably. The inner-upper-arm length threshold of less than 37% of mid-upper-arm circumference excludes a subject from that auscultatory verification, and the reference cuff bladder has to fall within the specified length and width ranges relative to arm circumference. That reduces the risk that an incorrectly sized cuff, rather than the device under test, drives the result.

Clause 5 also allows special patient populations, and the annex rationale discusses children, pregnancy, and other groups where blood pressure measurement behaves differently. Clause 7 adds separate requirements for pregnant patient populations, and Clause 8 adds separate requirements for atrial fibrillation (AF) patient populations.

Clinical performance criteria and methods

Clause 5.2 describes several clinical performance verification methods with a reference sphygmomanometer, including same-arm simultaneous, same-arm sequential, and opposite-limb simultaneous methods. These methods matter because the device may operate in a way that makes one comparison method more suitable than another, especially when the cuff inflation or deflation timing affects whether manual auscultation can be used.

For the same-arm methods, the reference readings are taken by observers using a reference sphygmomanometer, and the analysis uses paired determinations against the sphygmomanometer-under-test. The main pass criteria are a mean difference within ±5.0 mmHg and a standard deviation not greater than 8.0 mmHg, with additional subject-level acceptance criteria given in Table 1 and Table 2. For the opposite-limb method, the lateral difference between arms is compensated before the same acceptance criteria are applied.

Clause 6 uses reference invasive blood pressure monitoring equipment and requires patient distributions, a defined reference arterial site, and a procedure for determining reference blood pressure and measurement error. For this route, the document also addresses mean arterial pressure (MAP), irregular rhythm handling, and what to exclude when blood pressure varies too much during a recording. In practice, this is the route used when auscultation is not suitable or when the device is intended to display central or aortic blood pressure.

Special populations and disclosures

Clause 7 requires specific clinical performance verification in pregnant patients, including separate handling of normotensive, hypertensive, and pre-eclampsia groups. The accompanying information may claim suitability for pregnant patients only when that verification has been done; otherwise it must state that effectiveness has not been established in pregnant patients.

Clause 8 does the same for patients with AF. It requires a non-invasive reference method, sets inclusion criteria for stable outpatients with continuous AF, and changes the acceptance spread for the data analysis. The accompanying information may state suitability for AF only when the AF verification has been completed.

What terms does prEN ISO 81060-2 define?

prEN ISO 81060-2 defines the terms that control how the clinical study is described and reported. These definitions matter because they fix the meaning of the device, the reference method, and the result being verified.

• Accompanying information - Information supplied by the manufacturer with or on the device for the user or responsible organization, especially for safe use.
• Automated sphygmomanometer - ME equipment for non-invasive blood pressure estimation using an inflatable cuff, a pressure transducer, a deflation valve, and automatic blood pressure determination methods.
• Blood pressure - Pressure in the systemic arterial system of the body.
• Instructions for use (IFU) - The part of the accompanying information directed to the primary user and needed for safe and effective use.
• Mean arterial pressure (MAP) - The integral of one heartbeat cycle of the blood pressure curve divided by the cycle time.
• Reference - A measurement that has a known accuracy.
• Sphygmomanometer-under-test - The automated sphygmomanometer undergoing clinical performance verification.
• Verification - Confirmation through objective evidence that specified requirements have been fulfilled.

Who uses prEN ISO 81060-2?

prEN ISO 81060-2 is used by manufacturers of automated sphygmomanometers, clinical investigators, and test teams that plan or run clinical performance verifications. It is also used by quality, regulatory, and technical documentation staff who must prepare the clinical report, the IFU, and the technical description.

Hospitals, responsible organizations, and service personnel may use it when they assess whether a device’s intended use, patient population, and accompanying information match the verification that was performed. Buyers and evaluators use it to check whether a device has been clinically verified for the intended setting, such as home use, professional care, EMS, exercise stress testing, pregnancy, or AF.

What changed in prEN ISO 81060-2 from the previous edition?

prEN ISO 81060-2 states that clinical performance verification results from successful investigations according to previous versions of ISO 81060-2:2018 remain valid, and repeat verification is not required just to conform with this document.

Which standards are used with prEN ISO 81060-2?

prEN ISO 81060-2 uses ISO 14155:2026 for clinical investigation good clinical practice, so the verification is run as a formal human-subject clinical investigation. It uses ISO 81060-1:2007 for the non-automated sphygmomanometer reference context, and IEC 60601-2-34 for invasive blood pressure monitoring equipment.

These references matter because they define the clinical study framework, the comparison baseline for non-automated devices, and the invasive equipment that can be used as a reference method.

What does the prEN ISO 81060-2 document contain?

prEN ISO 81060-2 contains the clinical investigation framework, the reference-method procedures, the subject distribution rules, and the data-analysis criteria needed to verify intermittent automated blood pressure devices. It includes formulas for calculating differences, averages, standard deviations, and lateral difference compensation, plus acceptance tables for subject-level performance.

The document also contains figures that illustrate the same-arm simultaneous method, the same-arm sequential method, the opposite-limb simultaneous method, and the arm-measurement threshold used for auscultatory reference work. Annex A adds rationale for the major design choices, Annex B links clauses to IMDRF essential principles, and Annex C provides an alphabetical index of defined terms.

It also includes disclosure requirements for the technical description and accompanying information, so the verification result is not only measured but also communicated correctly to users and responsible organizations.

SLOVENSKI STANDARD
01-september-2026
Neinvazivni sfigmomanometri - 2. del: Klinično preverjanje delovanja
avtomatiziranih vrst merjenja s prekinitvami (ISO/DIS 81060-2:2026)
Non-invasive sphygmomanometers - Part 2: Clinical performance verification of
intermittent automated measurement type (ISO/DIS 81060-2:2026)
Nichtinvasive Blutdruckmessgeräte ¿ Teil 2: Klinische Leistungsbewertungsprüfung der
intermittierenden automatisierten Bauart (ISO/DIS 81060-2:2026)
Sphygmomanomètres non invasifs - Partie 2: Vérification des performances cliniques
pour type ponctuel à mesurage automatique (ISO/DIS 81060-2:2026)
Ta slovenski standard je istoveten z: prEN ISO 81060-2
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 81060-2
ISO/TC 121/SC 3
Non-invasive
Secretariat: ANSI
sphygmomanometers —
Voting begins on:
Part 2: 2026-06-22
Clinical performance verification
Voting terminates on:
2026-09-14
of intermittent automated
measurement type
ICS: 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 81060-2:2026(en)
DRAFT
ISO/DIS 81060-2:2026(en)
International
Standard
ISO/DIS 81060-2
ISO/TC 121/SC 3
Non-invasive
Secretariat: ANSI
sphygmomanometers —
Voting begins on:
Part 2:
Clinical performance verification
Voting terminates on:
of intermittent automated
measurement type
ICS: 11.040.55
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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BE CONSIDERED IN THE LIGHT OF THEIR
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RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 81060-2:2026(en)
ii
ISO/DIS 81060-2:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope (see Clause A.2) . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for clinical investigations . 6
4.1 Clinical investigation methods .6
4.2 Good clinical practice .7
4.3 Status of previous clinical performance verifications .7
4.4 Disclosure of summary of clinical performance verification .7
5 Clinical performance verification with a reference auscultatory sphygmomanometer . 7
5.1 Subject requirements.7
5.1.1 Number (see Clause A.3) .7
5.1.2 Sex distribution (see Clause A.4) .7
5.1.3 Age distribution (see Clause A.5) .8
5.1.4 Limb size distribution .8
5.1.5 Blood pressure distribution .10
5.1.6 Special patient populations (see Clause A.6).10
5.2 Clinical performance verification method with a reference sphygmomanometer .11
5.2.1 Subject preparation (see Clause A.7).11
5.2.2 Observer preparation (see Clause A.8) .11
5.2.3 Reference readings (see Clause A.9) . 12
5.2.4 Clinical performance verification methods.14
5.2.5 Additional requirements for a sphygmomanometer intended for use in exercise
stress testing environments (see Clause A.13) .24
5.2.6 Additional requirements for a sphygmomanometer intended for use in
ambulatory monitoring (see Clause A.14) . 25
6 Clinical performance verification with reference invasive blood pressure monitoring
equipment .26
6.1 Patient requirements . 26
6.1.1 Number . 26
6.1.2 Sex distribution (see Clause A.15) . 26
6.1.3 Age distribution (see Clause A.16) . 26
6.1.4 Limb size distribution . 28
6.1.5 Blood pressure distribution . 29
6.1.6 Special patient populations . 29
6.2 Clinical performance verification methods with reference invasive blood pressure
monitoring equipment . 30
6.2.1 Reference determination (see Clause A.17) . 30
6.2.2 Reference arterial site (see Clause A.18) . 30
6.2.3 Procedure .31
6.2.4 Determining the reference blood pressure (see Clause A.19) .32
6.2.5 Determining the error of the blood pressure measurement .32
6.2.6 Data analysis . 33
6.2.7 Mean arterial pressure (MAP) . 33
7 Pregnant patient populations (see Clause A.20) .33
8 Atrial fibrillation (AF) patient populations .34
Annex A (informative) Rationale and guidance .36
Annex B (informative) Reference to the IMDRF essential principles .46
Annex C (informative) Terminology — alphabetized index of defined terms . 47

iii
ISO/DIS 81060-2:2026(en)
Bibliography .48

iv
ISO/DIS 81060-2:2026(en)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations,
governmental and non-governmental, in liaison with ISO and IEC, also take part in the work.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of document should be noted. This document was drafted in accordance with the editorial rules of the ISO/
IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on the
ISO list of patent declarations received (see www.iso.org/patents) or the IEC list of patent declarations
received (see http://patents.iec.ch).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and Technical
Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical equipment.
[1]
This third edition cancels and replaces the second edition (ISO 81060-2:2013 ), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— same arm simultaneous method has been reinstated;
— numerous clarifications have been added and kPa equivalent values for the mmHg values have been
included.
A list of all parts in the ISO 81060 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO/DIS 81060-2:2026(en)
Introduction
Determining blood pressure is an important procedure that is clinically used to assess the status of a patient.
Blood pressure serves as aid to control the drug titration and fluid management and to provide warning
about the changes in patient's state of health.
Frequently determining blood pressure is routine during anaesthesia. Blood pressure serves to aid to
control drug titration and fluid management and to provide warning about the changes in the patient's state
of health.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this document, the auxiliary verb:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.
Annex A contains rationale and guidance.
Annex B maps the clauses and subclauses of this document with the relevant International Medical Device
Regulators Forum (IMDRF) essential principles.
Annex C contains an alphabetized index of defined terms.

vi
DRAFT International Standard ISO/DIS 81060-2:2026(en)
Non-invasive sphygmomanometers —
Part 2:
Clinical performance verification of intermittent automated
measurement type
1 Scope (see Clause A.2)
This document specifies the requirement and methods for the clinical performance verification of
ME equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure
by utilizing a cuff.
This document 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 document 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 environment and emergency medical services environment).
[2]
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical performance
verification according to this document.
This document specifies additional disclosure requirements for the accompanying information of
sphygmomanometers that conform with this document.
This document is not applicable to the clinical performance verification of a non-automated
sphygmomanometer as given in ISO 81060-1:2007 or invasive blood pressure monitoring equipment as
given in IEC 60601-2-34.
This document is not applicable to clinical performance verification of a set of cuffs that are not of same
materials and construction. Each type of cuff set is required to be evaluated separately according to this
document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14155:2026, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 81060-1:2007, Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-
automated measurement type
IEC 60601-2-34, 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 following terms and definitions apply.

ISO/DIS 81060-2:2026(en)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
NOTE For convenience, an alphabetized index of defined terms is found in Table C.1.
3.1
accompanying information
DEPRECATED: accompanying documents
DEPRECATED: accompanying documention
information supplied by the manufacturer (3.15) with or marked on a medical device or accessory for the
user or the responsible organisation (3.23), particularly regarding safe use
[3]
[SOURCE: ISO 20417:2026 , 3.2, modified – deleted notes.]
3.2
automated sphygmomanometer
ME equipment (3.17) used for the non-invasive estimation of the blood pressure (3.4) by utilizing an inflatable
cuff (3.7), a pressure transducer, a valve for deflation and displays used in conjunction with automatic
methods for determining blood pressure (3.4)
Note 1 to entry: Components of an automated sphygmomanometer (3.2) include manometer, cuff (3.7), valve for
deflation (often in combination with the valve for rapidly exhausting the pneumatic system), pump for inflation of the
bladder (3.3) and connection tubing.
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.201]
3.3
bladder
that part of the cuff (3.7) that is inflatable
[SOURCE: ISO 81060-1:2007, 3.2]
3.4
blood pressure
pressure in the systemic arterial system of the body
[SOURCE: ISO 81060-1:2007, 3.3]
3.5
clinical investigation
systematic investigation in one or more human subjects, undertaken to assess the clinical performance,
effectiveness or safety of a medical device
[SOURCE: ISO 14155:2026, 3.9]
3.6
clinical investigation report
document describing the design, conduct, statistical analysis and results of a clinical investigation (3.5)
[SOURCE: ISO 14155:2026, 3.11]
3.7
cuff
part of the sphygmomanometer (3.24) that is wrapped around the limb of the patient (3.20)
Note 1 to entry: A cuff (3.7) usually comprises a bladder (3.3) and an inelastic part that encloses the bladder (3.3), or
has an integral bladder (3.3) (i.e. the cuff (3.7), including the bladder (3.3), is one piece).
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.202]

ISO/DIS 81060-2:2026(en)
3.8
determination
determination value
result of the process of estimating blood pressure (3.4) by a sphygmomanometer (3.24)
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.203]
3.9
diastolic blood pressure
diastolic blood pressure value
minimum value of the blood pressure (3.4) resulting from a relaxation of the systemic ventricle
Note 1 to entry: Because of hydrostatic effects, this value should be determined with the cuff (3.7) at the same elevation
as the heart (phlebostatic axis).
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.204]
3.10
essential principles
essential principles of safety and performance
fundamental high-level requirements that, when conformed with, ensure a medical device or accessory is
safe and performs as intended
[3]
[SOURCE: ISO 20417:2026 , 3.10]
3.11
intended use
intended purpose
use for which a product or process is intended according to the specifications, instructions for use (3.13) and
other information supplied by the manufacturer (3.15)
[4]
[SOURCE: ISO/IEC Guide 63:2019 , 3.4, modified — deleted “or service” and replaced “instructions” with
“instructions for use”, “provided” with “supplied”, added “other” and deleted note.]
3.12
intermittent
〈non-invasive sphygmomanometer〉 utilizing a process of estimating blood pressure (3.4) that provides a
single set of pressure values from a number of heart beats
3.13
IFU
instructions for use
package insert
portion of the accompanying information (3.1) that is:
— directed to the primary user; and
— essential for the safe and effective use of a medical device or accessory
[3]
[SOURCE: ISO 20417:2026 , 3.16, modified —deleted notes.]
3.14
invasive blood pressure monitoring equipment
ME equipment (3.17) including associated pressure transducers, that is used for internal measurement or
monitoring of circulatory system pressures
[SOURCE: IEC 60601-2-34, 201.3.63]

ISO/DIS 81060-2:2026(en)
3.15
manufacturer
organization with responsibility for design or manufacture of a medical device or accessory with the
intention of making the medical device or accessory available for use, under its name; whether such
a medical device or accessory is designed or manufactured by that organization itself or on its behalf by
another organization
[5]
[SOURCE: IEC 60050-880 :—, 880-12-14, modified — deleted notes.]
3.16
mean arterial pressure
MAP
value of the integral of one heartbeat cycle of the blood pressure (3.4) curve divided by the time of that cycle
Note 1 to entry: Because of hydrostatic effects, this value should be determined with the cuff (3.7) at the same elevation
as the heart (phlebostatic axis).
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.206]
3.17
ME equipment
medical electrical equipment
electrical medical device having an applied part or transferring energy or substances to or from the patient
(3.20) or detecting such energy or substance transfer to or from the patient (3.20)
[5]
[SOURCE: IEC 60050-880 :—, 880-08-26, modified — deleted notes.]
3.18
non-automated sphygmomanometer
ME equipment (3.17) used for the non-invasive estimation of blood pressure (3.4) by utilizing an inflatable
cuff (3.7) with a pressure-sensing element, a valve for deflation, and a display used in conjunction with a
stethoscope or other manual methods for estimating blood pressure (3.4)
Note 1 to entry: Components of these instruments include a manometer, cuff (3.7), valve for deflation (often in
combination with the valve for rapidly exhausting the pneumatic system), hand pump or electro-mechanical pump
for inflation of the bladder (3.3), and connection tubing. A non-automated sphygmomanometer (3.18) can also contain
electro-mechanical components for cuff (3.7) pressure control.
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.208]
3.19
objective evidence
data supporting the existence or verity of something
Note 1 to entry: Objective evidence (3.19) can be obtained through observation, measurement, test or by other means.
[6]
[SOURCE: ISO 14971:2019 , 3.11]
3.20
patient
living being receiving healthcare services
Note 1 to entry: Living being means person or animal.
Note 2 to entry: Healthcare services include diagnostic, therapeutic, monitoring, surgical or dental procedures and
can be delivered in the home healthcare environment, professional healthcare environment, EMS environment or a
special environment.
Note 3 to entry: A patient (3.20) can be a user.
Note 4 to entry: Safety limit values can be different for different patients (3.20), especially for animal patients (3.20).
[5]
[SOURCE: IEC 60050-880 :—, 880-12-16]

ISO/DIS 81060-2:2026(en)
3.21
procedure
specified way to carry out an activity or a process
Note 1 to entry: Procedures (3.21) can be documented or not.
[7]
[SOURCE: ISO 9000:2015 , 3.4.5]
3.22
reference
measurement that has a known accuracy
3.23
responsible organisation
organization accountable for the installation, use, processing, maintenance, decommissioning or disposal of
a medical device or accessory and their detachable parts
Note 1 to entry: The responsible organization includes those individuals performing the activities for the responsible
organization including the preparation of the infrastructure needed to support the installation.
Note 2 to entry: The responsible organization can be, for example, a hospital, an individual healthcare professional
provider or a lay person. In home use applications, the patient (3.20), user and responsible organization can be one and
the same person.
Note 3 to entry: Education and training are included in “use”.
[5]
[SOURCE: IEC 60050-880 :—, 880-12-18]
3.24
sphygmomanometer
medical device for non-invasive estimation of systemic arterial blood pressure (3.4)
3.25
sphygmomanometer-under-test
automated sphygmomanometer (3.2) undergoing clinical performance verification (3.30)
3.26
systolic blood pressure
systolic blood pressure value
maximum value of the blood pressure (3.4) resulting from a contraction of the systemic ventricle
Note 1 to entry: Because of hydrostatic effects, this value should be determined with the cuff (3.7) at the same elevation
as the heart (phlebostatic axis).
[2]
[SOURCE: IEC 80601-2-30 :—, 201.3.216]
3.27
technical description
portion of the accompanying information (3.1) that is:
— directed to the responsible organisation (3.23) and service personnel; and
— essential for installation, preparation for the first use and safe use, maintenance or repair as well as
processing, transport or storage for the expected lifetime including decommissioning or disposal of a
medical device or accessory
[3]
[SOURCE: ISO 20417:2026 , 3.43, modified —deleted note 2.]
3.28
total limb circumference range
range, from the smallest limb circumference to the largest limb circumference, intended by the manufacturer
(3.15) for use with the sphygmomanometer (3.24)

ISO/DIS 81060-2:2026(en)
3.29
type test
test on one or more representative samples of a product, as designed and manufactured, with the objective
of determining conformity
Note 1 to entry: A representative sample means taken from production or being a production equivalent.
[5]
[SOURCE: IEC 60050-880 :—, 880-09-16]
3.30
verification
verified
confirmation, through the provision of objective evidence (3.19), that specified requirements have been
fulfilled
Note 1 to entry: The objective evidence (3.19) needed for a verification (3.30) can be the result of an inspection or of
other forms of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out for verification (3.30) are sometimes called a qualification process. In
short, verification (3.30) gives the confidence that the system was built correctly to meet identified requirements and
specifications.
Note 3 to entry: In the case of software specifically, verification (3.30) is conducted at various stages of development,
examining the software and its constituents to determine conformity.
Note 4 to entry: The word “verified (3.30)” is used to designate the corresponding status.
Note 5 to entry: In design and development, verification (3.30) concerns the inspection of the result of an activity to
determine conformity with the stated requirements.
[5]
[SOURCE: IEC 60050-880 :—, 880-14-24]
4 General requirements for clinical investigations
4.1 Clinical investigation methods
a) An automated sphygmomanometer shall undergo a clinical performance verification according to this
document in each mode of operation by either using:
EXAMPLE 1 Adult and neonatal modes.
EXAMPLE 2 Slow and fast cuff deflation rate modes.
1) a reference non-invasive auscultatory sphygmomanometer at the upper arm; or
2) a reference invasive blood pressure monitoring equipment.
b) The clinical investigation shall be considered a type test.
c) An automated sphygmomanometer intending to display central or aortic blood pressure shall utilize a
reference central or aortic invasive site for the clinical performance verification (see 6.2.2).
NOTE Such an automated sphygmomanometer is investigated according to Clause 6.
d) Consider conformity with the requirements of this subclause to exist when the criteria of the relevant
inspections and tests in this document are met.

ISO/DIS 81060-2:2026(en)
4.2 Good clinical practice
a) All clinical performance verifications shall be clinical investigations in accordance with the requirements
of ISO 14155:2026.
1) The requirements of this document, which are more specific than the corresponding requirements
of ISO 14155:2026, shall prevail.
b) Clinical performance verification 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.
c) All subjects shall be unique.
d) A subject shall only be used once in a clinical performance verification.
e) Check conformity by application of the requirements of ISO 14155:2026 and by inspection of the clinical
investigation report.
4.3 Status of previous clinical performance verifications
The clinical performance verification results for sphygmomanometers that have been successfully
[8]
investigated according to previous versions of ISO 81060-2:2018 remain valid and a clinical performance
verification need not be repeated to conform with this document.
4.4 Disclosure of summary of clinical performance verification
The technical description of a sphygmomanometer shall contain contact information permitting the
responsible organization to acquire a copy of the summary of the clinical performance verification.
5 Clinical performance verification with a reference auscultatory
sphygmomanometer
5.1 Subject requirements
5.1.1 Number (see Clause A.3)
a) A reference auscultatory sphygmomanometer clinical performance verification shall consist of a
minimum of 85 subjects.
b) If not otherwise specified, at least three valid paired blood pressures shall be taken for each subject.
c) There shall be a minimum of 255 valid paired blood pressures.
Check conformity by inspection of the clinical investigation report.
5.1.2 Sex distribution (see Clause A.4)
a) At least 30 % of the subjects shall be male.
b) At least 30 % of the subjects shall be female.
Check conformity by inspection of the clinical investigation report.

ISO/DIS 81060-2:2026(en)
5.1.3 Age distribution (see Clause A.5)
a) For a sphygmomanometer intended for use on patients older than 12 years, at least 85 subjects shall be
included in the clinical performance verification.
b) For a sphygmomanometer additionally intended for use in patients aged between 1 year and 12 years, at
least 35 paediatric subjects shall be included in the clinical performance verification.
1) At least 25 % of the paediatric subjects shall be between 1 and 4 years of age.
2) At least 25 % of the paediatric subjects shall be between 4 and 8 years of age.
3) At least 25 % of the paediatric subjects shall be between 8 and 12 years of age.
NOTE 1 Minimum total of 85 subjects (35 children aged 1 year to 12 years and 50 subjects older than
12 years).
NOTE 2 Auscultation becomes technically feasible once the infant reaches 1 year of age.
c) In case patients aged between 1 year and 3 years of age have been covered by including at least 3 patients
in addition to the neonatal population using a reference invasive blood pressure monitoring equipment
[see 6.1.3.2, list item d) and 5.1.3, list item b)], the number of such patients can be reduced to 10% of the
paediatric subjects.
d) If the sphygmomanometer has a special mode for children, in that mode, children shall be considered
a special patient population (see 5.1.6) and shall have the same age distribution requirements as
5.1.3, list item b) and 5.1.3, list item c).
1) In such a clinical performance verification, children are exempt from the blood pressure distribution
requirements of 5.1.5.
2) Patients of less than 3 years of age are exempt from:
i) the sex distribution requirements of 5.1.2; and
ii) the limb size distribution requirements of 5.1.4.
e) Patients aged less than 1 year shall not be included in a clinical performance verification utilizing
auscultatory reference readings by observers with a reference sphygmomanometer.
1) If the auscultatory clinical performance verification does not include subjects less than three
years of age, those subjects may be included in the clinical performance verification with reference
invasive blood pressure monitoring equipment (see Clause 6).
2) Alternatively, the manufacturer may limit the intended use to greater than 3 years of age.
f) Check conformity by inspection of the accompanying information and the clinical investigation report.
5.1.4 Limb size distribution
a) For a clinical performance verification with only one cuff, the requirements in 5.1.4, list item d) to
5.1.4, list item i) apply based on the limb circumference range ( ) of that cuff.
b) For a clinical performance verification with more than one cuff to limit the overlap of all cuffs intended
for use with a sphygmomanometer, Formula (1) shall apply.
c) If the distribution of cuffs is not in accordance with Formula (1), multiple clinical performance
verifications with subsets of these cuffs shall be performed separately.

ISO/DIS 81060-2:2026(en)
(1)
where
is the limb circumference range for the individual cuff in cm; and
is the total limb circumference range in cm.
d) For cuffs having a size of the limb circumference range ( ) of 12 cm or less:
1) at least 40 % of the subjects allocated to this cuff shall have a limb circumference which lies within
the upper half of the specified range of use of the cuff;
2) at least 40 % of the subjects allocated to this cuff shall have a limb circumference within the lower
half of the specified range of use of the cuff;
3) for a sphygmomanometer intended for use with multiple cuff sizes, each cuff having a size of the
limb circumference range of 12 cm or less shall be tested on at least subjects as calculated
according to Formula (2); and
4) if , according to Formula (2) is less than 12 subjects, shall be a minimum of 12 subjects.
(2)
where
is the total number of subjects in the clinical performance verification;
is the limb circumference range for the individual cuff in cm; and
is the total limb circumference range in cm.
e) For cuffs having a size of the limb circumference range ( ) of more than 12 cm and less than or equal
to 16 cm:
1) at least 20 % of the subjects allocated to this cuff shall have a limb circumference which lies within
each quartile of the limb circumference range;
2) for a sphygmomanometer intended for use with multiple cuff sizes, each cuff having a size of the
limb circumference range of more than 12 cm and less than or equal to 16 cm shall be tested on at
least subjects as calculated according to Formula (3); and
3) if , according to Formula (3) is less than 12 subjects, shall be a minimum of 12 subjects.
(3)
where
is the total number of subjects in the clinical performance verification;
is the limb circumference range for the individual cuff in cm; and
is the total limb circumference range in cm.
f) For cuffs having a size of the limb circumference range ( ) of greater than 16 cm:
1) at least 20 % of the subjects allocated to this cuff shall have a limb circumference which lies within
each quartile of the limb circumference range;
2) at least 10 % of the subjects allocated to this cuff shall have a limb circumference which lies within
the highest octile of the limb circumference range;
3) at least 10 % of the subjects allocated to this cuff shall have a limb circumference within the lowest
octile of the limb circumference range;

ISO/DIS 81060-2:2026(en)
4) for a sphygmomanometer intended for use with multiple cuff sizes, each cuff having a size of the
limb circumference range of 16 cm and more shall be tested on at least subjects as calculated
according to Formula (3); and
5) if , according to Formula (3) is less than 12 subjects, shall be a minimum of 12 subjects.
g) The clinical investigation report shall provide the specified arm circumference range of each cuff in cm.
h) The clinical investigation report shall include plots showing all subject results by arm circumference,
where the Y axis shows the difference between sphygmomanometer-under-test and reference blood
pressures and the X axis shows the actual arm circumference of the subjects.
1) These plots should also indicate the arm circumference limits of each cuff with vertical lines.
2) Data points from each cuff should be indicated using different colours or symbols.
3) Plots shall be provided for both:
i) systolic blood pressure; and
ii) diastolic blood pressure.
i) The clinical investigation report shall include Bland-Altman plots showing all subject results, where the
Y axis shows the difference between sphygmomanometer-under-test and reference blood pressures and
the X axis shows the average of the sphygmomanometer-under-test and reference blood pressures.
1) Plots shall be provided for both:
i) systolic blood pressure; and
ii) diastolic blood pressure.
j) Check conformity by inspection of the clinical investigation report.
5.1.5 Blood pressure distribution
a) For the patient population older than 12 years:
1) At least 5 % of the reference blood pressure readings shall have a systolic blood pressure ≤100
mmHg (13,33 kPa).
2) At least 5 % of the reference blood pressure readings shall have a systolic blood pressure ≥160
mmHg (21,33 kPa).
3) At least 20 % of the reference blood pressure readings shall have a systolic blood pressure ≥140
mmHg (18,66 kPa).
4) At least 5 % of the reference blood pressure readings shall have a diastolic blood pressure ≤60
mmHg (8,0 kPa).
5) At least 5 % of the reference blood pressure readings shall have a diastolic blood pressure ≥100
mmHg (13,33 kPa).
6) At least 20 % of the reference blood pressure readings shall have a diastolic blood pressure ≥85
mmHg (11,33 kPa).
b) Check conformity by inspection of the clinical investigation report.
5.1.6 Special patient populations (see Clause A.6)
a) A sphygmomanometer that is intended for use in a special patient population where there is objective
evidence that the accuracy of the sphygmomanometer can be problematic in that patient population,
shall undergo clinical performance verification in that patient population.

ISO/DIS 81060-2:2026(en)
b) If the sphygmomanometer has passed clinical performance verification according to the requirements
of 5.1.1 and 5.2, it shall then undergo clinical performance verification in at least an additional 35 special
population subjects.
c) If the sphygmomanometer has not successfully undergone clinical performance verification according
to the requirements of 5.1.1 and 5.2, the clinical performance verification in accordance with the
requirements of 5.1.1 and 5.2 shall consist only of subjects from the special patient population.
d) The special patient population shall be defined in clear terms and address the following attributes:
1) sex (see 5.1.2);
2) age (see 5.1.3);
3) limb size (see 5.1.4); and
4) blood pressure (see 5.1.5).
e) A summary of the description of the special patient population information shall be disclosed in the
sphygmomanometer-under-test IFU.
f) Check conformity by inspection of the sphygmomanometer-under-test IFU and the clinical investigation
report.
5.2 Clinical performance verification method with a reference sphygmomanometer
5.2.1 Subject preparation (see Clause A.7)
a) Unless otherwise indicated by the IFU of the sphygmomanometer-under-test, position the subject such
that the subject:
1) is comfortable;
2) is seated with legs uncrossed and feet flat on the floor;
3) has the back, elbow and forearm supported; and
4) has the measurement site at the level of the left ventricle of the heart.
b) It is recommended that:
1) the subject be as relaxed as possible; and
2) the subject avoids talking during the entire procedure.
c) The cuff shall be applied on
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