EN IEC 80601-2-30:2019

SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST EN 80601-2-30:2010
SIST EN 80601-2-30:2010/A1:2015
Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov (IEC 80601-2-
30:2018)
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-
30:2018)
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven
Blutdruckmessgeräten (IEC 80601-2-30:2018)
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base
et les performances essentielles de sphygmomanomètres non invasifs automatiques
(IEC 80601-2-30:2018)
Ta slovenski standard je istoveten z: EN IEC 80601-2-30:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 80601-2-30

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 11.040 Supersedes EN 80601-2-30:2010
English Version
Medical electrical equipment - Part 2-30: Particular requirements
for the basic safety and essential performance of automated
non-invasive sphygmomanometers
(IEC 80601-2-30:2018)
Appareils électromédicaux - Partie 2-30: Exigences Medizinische elektrische Geräte - Teil 2-30: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles de sphygmomanomètres non invasifs wesentlichen Leistungsmerkmale von automatisierten nicht-
automatiques invasiven Blutdruckmessgeräten
(IEC 80601-2-30:2018) (IEC 80601-2-30:2018)
This European Standard was approved by CENELEC on 2018-04-26. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-30:2019 E

European foreword
The text of document 62D/1548/FDIS, future edition 2 of IEC 80601-2-30, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 80601-2-30:2019.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-11-24
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2022-05-24
document have to be withdrawn
This document supersedes EN 80601-2-30:2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 80601-2-30:2018 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1-8:2006 NOTE Harmonized as EN 60601-1-8:2007 (not modified)
ISO 81060-1:2007 NOTE Harmonized as EN ISO 81060-1:2012 (not modified)
IEC 60601-1-3 NOTE Harmonized as EN 60601-1-3
IEC 60601-1-9:2007 NOTE Harmonized as EN 60601-1-9:2008 (not modified)
IEC 60721-3-7 NOTE Harmonized as EN 60721-3-7

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year

Replacement
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013  + A1 2015
Addition
IEC 60068-2-27 2008 Environmental testing - Part 2-27: Tests - EN 60068-2-27 2009
Test Ea and guidance: Shock
IEC 60068-2-64 2008 Environmental testing - Part 2-64: Tests - EN 60068-2-64 2008
Test Fh: Vibration, broadband random and
guidance
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
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: EN 60601-1-11 2015
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 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 EN 62366-1 2015
usability engineering to medical devices
- -  + AC 2015
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 2018 Small-bore connectors for liquids and - -
gases in healthcare applications -- Part 1:
General requirements
ISO 81060-2 2013 Non-invasive sphygmomanometers – PartE N ISO 81060-2 2014
2: Clinical validation investigation of
automated measurement type
IEC 80601-2-30
Edition 2.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

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

of automated non-invasive sphygmomanometers

Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances

essentielles des sphygmomanomètres non invasifs automatiques

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-5425-7

– 2 – IEC 80601-2-30:2018 © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 13
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 . 17
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
201.101 Requirements for CUFFS . 25
201.102 * Connection tubing and CUFF connectors . 26
201.103 Unauthorized access. 26
201.104 * Maximum inflating time . 26
201.105 * Automatic cycling modes . 27
201.106 * Clinical accuracy . 31
202 Electromagnetic disturbances – Requirements and tests . 31
206 Usability . 34
210 Requirements for the development of physiologic closed-loop controllers . 35
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 35
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment . 35
Annexes . 37
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 38
Annex AA (informative) Particular guidance and rationale . 41
Annex BB (informative) Environmental aspects . 50
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 51
Bibliography . 54
Index of defined terms . 56

IEC 80601-2-30:2018 © IEC 2018 – 3 –
Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLE
FAULT CONDITION . 21
Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged overpressure
in SINGLE FAULT CONDITION . 22
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION and
SINGLE FAULT CONDITION . 27
Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION . 28
Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION . 28
Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 29
Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 30
Figure 202.101 – HF SURGICAL EQUIPMENT test layout . 33
Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 34

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – CUFF deflation pressure . 18
Table 201.103 – CUFF inflation pressure . 26
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or
their parts . 38
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts . 38
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS . 39
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS . 39
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS . 40
Table AA.1 – Summary of requirements by mode . 47
Table BB.1 – Environmental aspects addressed by clauses of this document . 50
Table CC.1 – Correspondence between this particular standard and the ESSENTIAL
PRINCIPLES . 51

– 4 – IEC 80601-2-30:2018 © 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
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC
Publication(s)"). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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:
IEC 80601-2-30:2018 © IEC 2018 – 5 –
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
: SMALL CAPITALS.
NOTED
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.
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;
_____________
1 Figures in square brackets refer to the Bibliography.

– 6 – IEC 80601-2-30:2018 © IEC 2018
– "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.

IEC 80601-2-30:2018 © IEC 2018 – 7 –
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 © 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 non-continuous indirect estimation of the
BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect 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 estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD
PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect 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
PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 201.3.201.
_____________
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.

IEC 80601-2-30:2018 © IEC 2018 – 9 –
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, 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 3.147, 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 © 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 54.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic 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 60068-2-64:2008, 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 60601-2-2:2017, 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
IEC 80369-5:2016, Small-bore connectors for liquids and gases in healthcare applications –
Part 5: Connectors for limb cuff inflation applications

IEC 80601-2-30:2018 © IEC 2018 – 11 –
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 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,
IEC 60601-1-8, IEC 60601-2-2:2017 and IEC 62366-1:2015 and the following apply.
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 56.
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
CUFF
part of the AUTOMATED SPHYGMOMANOMETER that is wrapped around the limb of the PATIENT
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.
_____________
Under preparation. Stage at the time of publication: ISO/FDIS 80369-1:2017.

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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 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.
201.3.208
NON-AUTOMATED SPHYGMOMANOMETER
ME EQUIPMENT used for the non-invasive 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

IEC 80601-2-30:2018 © IEC 2018 – 13 –
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.
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 202.8.101
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
Reproducibility of the BLOOD PRESSURE DETERMINATION and 201.12.1.107
low and high BLOOD PRESSURE PHYSIOLOGICAL ALARM CONDITIONS (if 201.12.3.101
provided),
or generation of a TECHNICAL ALARM CONDITION 201.11.8.102
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.

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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 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.
201.7.2.103 * AUTOMATED SPHYGMOMANOMETER intended for self-use in public areas
If the AUTOMATED SPHYGMOMANOMETER is intended for
...