IEC 80601-2-30:2018

IEC 80601-2-30
Edition 2.0 2018-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers

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IEC 80601-2-30
Edition 2.0 2018-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –

Part 2-30: Particular requirements for the basic safety and essential performance

of automated non-invasive sphygmomanometers

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-5515-5

– 2 – IEC 80601-2-30:2018 RLV © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 27
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 27
201.101 Requirements for CUFFS . 27
201.102 * Connection tubing and CUFF connectors . 28
201.103 Unauthorized access. 28
201.104 * Maximum inflating time . 28
201.105 * Automatic cycling modes . 29
201.106 * Clinical accuracy . 33
202 Electromagnetic compatibility disturbances – Requirements and tests . 33
206 Usability . 37
210 Requirements for the development of physiologic closed-loop controllers . 38
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 38
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment . 38
Annexes . 39
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 40
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (informative) Environmental aspects . 53
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 54
Bibliography . 54
Index of defined terms . 61

Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure
in SINGLE FAULT CONDITION . 22
Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged
overpressure in SINGLE FAULT CONDITION . 23
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION
and SINGLE FAULT CONDITION . 29
Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION . 30
Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION . 31
Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 31
Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 32
Figure 202.101 – HF SURGICAL EQUIPMENT test layout . 36
Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 37

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – CUFF deflation pressure . 19
Table 201.103 – CUFF inflation pressure . 28
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS
or their parts . 40
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts . 41
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS . 41
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS . 41
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS . 42
Table AA.1 – Summary of requirements by mode . 50
Table BB.1 – Environmental aspects addressed by clauses of this document . 53
Table CC.1 – Correspondence between this particular standard
and the ESSENTIAL PRINCIPLES . 54

– 4 – IEC 80601-2-30:2018 RLV © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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This redline version of the official IEC Standard allows the user to identify the changes
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International standard IEC 80601-2-30 has been prepared by a Joint Working Group of
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and of subcommittee SC3: Lung ventilators and related
equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
This second edition cancels and replaces the first edition published in 2009 and
Amendment 1:2013. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 [1] ,
and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015;
b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12;
c) changing an OPERATOR-accessible CUFF-sphygmomanometer connector from not
compatible with the ISO 594 series to compatible with the ISO 80369 series;
d) added additional requirements for public self-use sphygmomanometers;
e) added a list of PRIMARY OPERATING FUNCTIONS.
This publication is published as a double logo standard.
The text of this document is based on the following documents of IEC:
FDIS Report on voting
62D/1548/FDIS 62D/1560/RVD
Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 14 P members
out of 15 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by
the clause number. References to subclauses within this particular standard are by number
only.
_____________
1 Figures in square brackets refer to the Bibliography.

– 6 – IEC 80601-2-30:2018 RLV © IEC 2018
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 Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance
with this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the 80601 International standard, published under the general title Medical
electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised 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 the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of an AUTOMATED SPHYGMOMANOMETER.
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington DC in 1979,
a "General guidance and rationale" section giving some explanatory notes, where appropriate,
about the more important requirements is included in Annex AA. It is considered that
knowledge of the reasons for these requirements will not only facilitate the proper application
of the standard but will, in due course, expedite any revision necessitated by changes in
clinical practice or as a result of developments in technology. However, the Annex AA does
not form part of the requirements of this document.

– 8 – IEC 80601-2-30:2018 RLV © IEC 2018
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL
PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT,
which by means of an inflatable CUFF, are used for intermittent non-continuous indirect
measurement estimation of the BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect measurement DETERMINATION of the BLOOD PRESSURE without arterial
puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for
this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a
DETERMINATION.
This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent,
indirect measurement estimation of the BLOOD PRESSURE without arterial puncture,
ME EQUIPMENT with automatic methods for estimating BLOOD PRESSURE, including BLOOD
PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect measurement estimation of the BLOOD PRESSURE without arterial
puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays
used in conjunction with a stethoscope or other manual methods for determining BLOOD
PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2].
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 201.3.201.
PERFORMANCE
_____________
2 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.

201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 is amended by this particular standard. IEC 60601-1-2, IEC 60601-1-6,
IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 apply as modified in Clauses 202, 206,
210, 211 and 212 respectively. IEC 60601-1-3 [3] does not apply. All other published
collateral standards in the IEC 60601-1 series apply as published [1] [4].
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x",
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

– 10 – IEC 80601-2-30:2018 RLV © IEC 2018
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 58.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007 2014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral Standard: Electromagnetic compatibility
disturbances – Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD 1:2013
Addition:
IEC 60068-2-27:2008, Environmental testing – Part 2-27: Tests – Test Ea and guidance:
Shock
IEC 60068-2-31:2008, Environmental testing – Part 2-31: Tests – Test Ec: Rough handling
shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broad-
band random and guidance
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD 1:2012
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
IEC 60601-1-11:2015, 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 the home healthcare environment
IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
IEC 60601-2-2:2009 2017, Medical electrical equipment – Part 2-2: Particular requirements
for the basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain
other medical equipment – Part 1: General requirements
ISO 594-2:1991, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other
medical equipment – Part 2: Lock fittings
IEC 80369-5:2016, Small-bore connectors for liquids and gases in healthcare applications –
Part 5: Connectors for limb cuff inflation applications
ISO 80369-1:— , Small-bore connectors for liquids and gases in healthcare applications –
Part 1: General requirements
ISO 81060-2:2013, Non-invasive sphygmomanometers – Part 2: Clinical validation
investigation of automated measurement type
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1-2:2007, IEC 60601-1-8:2006, IEC 60601-2-2:2009 2017 and IEC 62366-1:2015
and the following apply, except as follows.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 61.
Addition:
201.3.201
AUTOMATED SPHYGMOMANOMETER
ME EQUIPMENT used for the non-invasive estimation of the BLOOD PRESSURE by utilizing an
inflatable CUFF, a PRESSURE TRANSDUCER, a valve for deflation, and/or displays used in
conjunction with automatic methods for determining BLOOD PRESSURE
Note 1 to entry: Components of an AUTOMATED SPHYGMOMANOMETER include manometer, CUFF, valve for deflation
(often in combination with the valve for rapidly exhausting the PNEUMATIC SYSTEM), pump for inflation of the
BLADDER, and connection tubing.
201.3.202
BLADDER
part of the CUFF that is inflatable
[ISO 81060-1:2007, definition 3.2]
201.3.203
BLOOD PRESSURE
pressure in the systemic arterial system of the body
[ISO 81060-1:2007, definition 3.3]
201.3.202
CUFF
part of the AUTOMATED SPHYGMOMANOMETER that is wrapped around the limb of the PATIENT
_____________
Under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2017.

– 12 – IEC 80601-2-30:2018 RLV © IEC 2018
Note 1 to entry: A CUFF usually comprises a BLADDER and an inelastic part that encloses the BLADDER, or has an
integral BLADDER (i.e., the CUFF, including the BLADDER, is one piece).
[SOURCE: ISO 81060-1:2007 [2], 3.5, modified – In the definition, "non-automated" has been
replaced by "automated", and in the Note 1 to entry "might comprise" has been replaced by
"usually comprises".]
201.3.203
DETERMINATION
DETERMINATION VALUE
result of the PROCESS of estimating BLOOD PRESSURE by the AUTOMATED SPHYGMOMANOMETER
201.3.204
DIASTOLIC BLOOD PRESSURE
DIASTOLIC BLOOD PRESSURE VALUE
minimum value of the BLOOD PRESSURE as a result of relaxation of the systemic ventricle
Note 1 to entry: Because of hydrostatic effects, this value should be determined with the CUFF at the level of the
heart.
201.3.207
HOME HEALTHCARE ENVIRONMENT
dwelling place in which a patient lives or other environments that patients can occupy,
excluding professional healthcare facility environments where operators with medical training
are continually available when patients are present
NOTE 1 Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres, dental
offices, freestanding birthing centres, limited care facilities, multiple treatment facilities and ambulance services.
NOTE 2 In some countries, nursing homes are considered professional healthcare facilities.
NOTE 3 The home healthcare environment includes use in the outdoor environment and in personal automobiles.
4)
[IEC 60601-1-11___ , definition 3.2]
201.3.205
LONG-TERM AUTOMATIC MODE
mode in which a timer, set by the OPERATOR, initiates multiple DETERMINATIONS
201.3.206
MEAN ARTERIAL PRESSURE
MEAN ARTERIAL PRESSURE VALUE
value of the integral of one heartbeat cycle of the BLOOD PRESSURE curve divided by the time
of that cycle
Note 1 to entry: Because of hydrostatic effects, this value should be determined with the CUFF transducer at the
level of the heart.
201.3.207
NEONATAL MODE
mode of AUTOMATED SPHYGMOMANOMETER for use with neonates or infants
Note 1 to entry: The approximate age range for a newborn (neonate) is from birth to 1 month [5] [6].
Note 2 to entry: The approximate age range for an infant is from 1 month to 2 years [5] [6]. For the purposes of
this document, up to 3 years of age are considered infants (see ISO 81060-2:2013, 6.1.3).
Note 3 to entry: The NEONATAL MODE is used to limit the maximum pressure to 150 mmHg and frequently has a
different algorithm from other modes intended for older PATIENTS.
_____________
IEC 60601-1-11___, 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 the home healthcare environment (in preparation).

201.3.208
NON-AUTOMATED SPHYGMOMANOMETER
ME EQUIPMENT used for the non-invasive measurement estimation of the BLOOD PRESSURE by
utilizing an inflatable CUFF with a pressure-sensing element, a valve for deflation, and display
used in conjunction with a stethoscope or other manual methods for estimating BLOOD

PRESSURE
Note 1 to entry: Components of these instruments include manometer, CUFF, 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, and connection tubing. A NON-AUTOMATED SPHYGMOMANOMETER can also contain
electro-mechanical components for pressure control.
[SOURCE: ISO 81060-1:2007 [2], 3.11, modified – The definition and the note to entry have
been rephrased.]
201.3.209
PATIENT SIMULATOR
equipment for simulating the oscillometric CUFF pulses and/or auscultatory signals during
inflation and deflation
Note 1 to entry: This equipment is not used for testing accuracy but is used in assessing stability of performance.
201.3.210
PNEUMATIC SYSTEM
part of the AUTOMATED SPHYGMOMANOMETER that includes all pressurized and pressure-
controlling components
EXAMPLES CUFF, tubing, connectors, valves, PRESSURE TRANSDUCER and pump.
[SOURCE: ISO 81060-1:2007 [2], 3.16, modified – In the definition, replacement of "non
automated" by "automated", and in the examples, addition of "pressure".]
201.3.211
PRESSURE TRANSDUCER
component that transforms sensed pressure into an electrical signal
201.3.212
PROTECTION DEVICE
part of ME EQUIPMENT that, without intervention by the OPERATOR, protects the PATIENT from
hazardous output due to incorrect delivery of energy or substances
201.3.213
SELF-MEASUREMENT AUTOMATIC MODE
mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated and overseen by the
OPERATOR and in which a limited number of repeated DETERMINATIONS are made over a finite
period
201.3.214
SHORT-TERM AUTOMATIC MODE
*
mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated by the OPERATOR and in
which rapid repetitive automatic DETERMINATIONS are made within a specified time period
201.3.215
SYSTOLIC BLOOD PRESSURE
SYSTOLIC BLOOD PRESSURE VALUE
maximum value of the BLOOD PRESSURE as a result of the contraction of the systemic ventricle
Note 1 to entry: Because of hydrostatic effects, this value should be determined with the CUFF at the level of the
heart.
– 14 – IEC 80601-2-30:2018 RLV © IEC 2018
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER are
found in the subclauses listed in Table 201.101.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Electrosurgery interference recovery 202.6.2.101
202.8.101
a
Limits of the error of the manometer , 201.12.1.102
or generation of a TECHNICAL ALARM CONDITION 201.11.8.102
201.12.1.101
Limits of the change in the error Reproducibility of the BLOOD PRESSURE 201.12.1.107
DETERMINATION and
201.12.3.101
low and high BLOOD PRESSURE PHYSIOLOGICAL ALARM CONDITIONS (if
provided),
201.11.8.102
or generation of a TECHNICAL ALARM CONDITION 201.12.1.101
a
202.8.1.101 d) indicates methods of evaluating limits of the error of the manometer as
acceptance criteria following specific tests required by this document.

201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.4 * ACCESSORIES
Addition:
A CUFF shall be marked with an indication of the correct positioning for the CUFF on the
designated limb over the artery.
Additional subclauses:
201.7.2.101 Display of AUTOMATED SPHYGMOMANOMETERS
If abbreviations are used on the display, they shall be as follows:
– "S" or "SYS" for the value of SYSTOLIC BLOOD PRESSURE;
– "D" or "DIA" for the value of DIASTOLIC BLOOD PRESSURE;
– "M" or "MAP" for the value of MEAN ARTERIAL PRESSURE.
Single letter abbreviations shall be positioned in such a way as to avoid confusion with
SI units.
The numerical step of BLOOD PRESSURE readings shall be 1 mmHg or 0,1 kPa.
201.7.2.102 automated sphygmomanometers for home healthcare environment
If the AUTOMATED SPHYGMOMANOMETER is intended for use in the HOME HEALTHCARE
ENVIRONMENT, the sales packaging shall display information needed by the end user including,
as a minimum:
– identification of the appropriate arm circumference;
– the operating and storage temperature and humidity ranges;
– any special requirements for a battery-powered AUTOMATED SPHYGMOMANOMETER.
201.7.2.103102 * AUTOMATED SPHYGMOMANOMETER with NEONATAL MODE
If an AUTOMATED SPHYGMOMANOMETER is intended for use with neonatal PATIENTS and other
PATIENTS, it should have means for detecting that a CUFF intended for use with a neonatal
PATIENT is connected to the AUTOMATED SPHYGMOMANOMETER and means for automatically
placing the AUTOMATED SPHYGMOMANOMETER in NEONATAL MODE when such a CUFF is present.
If these means are not present, the instructions for use shall describe the method for placing
the AUTOMATED SPHYGMOMANOMETER into NEONATAL MODE and include a warning statement
describing the RISKS associated with using other than the NEONATAL MODE on a neonatal
PATIENT.
All ACCESSORIES intended for use only in the NEONATAL MODE and where the use in other
modes results in an unacceptable RISK shall be marked for neonatal use only.
201.7.2.104103  * AUTOMATED SPHYGMOMANOMETER intended for public self-use in
public areas
If the AUTOMATED SPHYGMOMANOMETER is intended for self-use in public areas, it shall be
marked on the USER INTERFACE with the following:
a) precautions for use, including a statement concerning the need to consult a physician for
interpretation of BLOOD PRESSURE measurements values;
b) adequate operating instructions; and
c) this sphygmomanometer complies with IEC 80601-2-30:2017.
EXAMPLES Self-measurement station in a pharmacy, fitness centre, workplace intended for use by the general
population without professional assistance.
If intended for use with a single CUFF size, the AUTOMATED SPHYGMOMANOMETER shall be
marked on the USER INTERFACE with the following:
d) the range of arm circumference for which the CUFF is intended – specifically minimum and
maximum upper arm (midpoint) circumference thresholds in centimetres and in inches;
and
e) a statement to the effect that results might not be accurate if your arm is outside specified
circumference range.
– 16 – IEC 80601-2-30:2018 RLV © IEC 2018
201.7.2.105104 * Component replacement
If a component can be replaced by the OPERATOR or SERVICE PERSONNEL, and if replacement
could affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the AUTOMATED
SPHYGMOMANOMETER, the AUTOMATED SPHYGMOMANOMETER or the component shall be marked
with either a caution to the effect that substitution of a component different from that supplied
might result in measurement error, or with a safety sign ISO 7010-M002 (see
IEC 60601-1:2005, Table D.2, safety sign 10).
EXAMPLES CUFF, microphone, connection tube, external power supply
201.7.2.106105 Disposal
The AUTOMATED SPHYGMOMANOMETER and its parts shall be marked with regard to disposal, as
appropriate, in accordance with national or regional regulations.

NOTE See also IEC 60601-1-9 [4].
201.7.9.2 Instructions for use
201.7.9.2.1 General
Replacement of the first three dashed items:
– the use of the AUTOMATED SPHYGMOMANOMETER as intended by the MANUFACTURER, and in
particular:
1) intended medical indication;
EXAMPLE 1 Condition(s) or disease(s) to be screened for, monitored, treated, diagnosed, or prevented.
2) any known restrictions on use or contraindication(s) to the use of the AUTOMATED
SPHYGMOMANOMETER;
EXAMPLE 2 AUTOMATED SPHYGMOMANOMETER for use in an ambulance or helicopter, for use in the HOME
HEALTHCARE ENVIRONMENT, for use with neonatal or pre-eclamptic PATIENTS.
3) intended PATIENT population, including whether or not the AUTOMATED
SPHYGMOMANOMETER is intended:
i) for use with neonatal PATIENTS,
ii) for use with pregnant, including pre-eclamptic, PATIENTS;
EXAMPLE 3 Age, weight, region of body, health, condition or diagnosis.
4) intended placement of the CUFF; and
5) intended conditions of use;
EXAMPLE 4 Environment, including hygienic, requirements, frequency of use, location, mobility.
– the frequently used functions;
– the permissible environmental conditions of use, including at least a temperature range of
10 °C to 40 °C with a relative humidity range of 15 % to 85 % (non-condensing).
201.7.9.2.2 Warning and safety notices
Addition, following the note:
The instructions for use shall include a warning:
aa) regarding the effect of blood flow interference and resulting harmful injury to the PATIENT
caused by continuous CUFF pressure due to connection tubin
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