IEC 80601-2-30:2009

IEC 80601-2-30
Edition 1.0 2009-01
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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by

any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or

IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.

Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette

publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: csc@iec.ch
Tél.: +41 22 919 02 11
Fax: +41 22 919 03 00
IEC 80601-2-30
Edition 1.0 2009-01
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
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040 ISBN 978-2-88910-781-0

– 2 – 80601-2-30 © IEC:2009
CONTENTS
FOREWORD.4

INTRODUCTION.7

201.1 Scope, object and related standards .8

201.2 Normative references.10

201.3 Terms and definitions.10

201.4 General requirements .13

201.5 General requirements for testing ME EQUIPMENT .13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS.13
201.7 ME EQUIPMENT identification, marking and documents .13
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 .23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).23
201.15 Construction of ME EQUIPMENT .23
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 compatibility – Requirements and tests .31
Annexes .34
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.35

Annex AA (informative) Particular guidance and rationale.38
Annex BB (informative) Environmental aspects .46
Annex CC (informative) Reference to the essential principles .47
Bibliography.49
Index of defined terms .51

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

80601-2-30 © IEC:2009 – 3 –
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 .35
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts .36
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS .36
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS .36
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS .37
Table AA.1 – Summary of requirements by mode.43
Table BB.1 – Environmental aspects addressed by clauses of this standard .46
Table CC.1 – Correspondence between this particular standard and the essential
principles .47

– 4 – 80601-2-30 © IEC:2009
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 IEC
subcommittee 62D: Electrical equipment, of IEC technical committee 62: Electrical equipment
in medical practice and ISO subcommittee SC3: Lung ventilators and related equipment, of
ISO technical committee 121: Anaesthetic and respiratory equipment.
This first edition of IEC 80601-2-30 cancels and replaces the second edition of
IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well
as an alignment with the third edition of IEC 60601-1. Specific technical changes include:
expansion of the scope to include all AUTOMATED SPHYGMOMANOMETERS including those where
the PATIENT is the OPERATOR, identification of ESSENTIAL PERFORMANCE, new clinical accuracy
requirements, additional mechanical strength requirements and prohibition of OPERATOR
accessible 'Luer' connectors in the PNEUMATIC SYSTEM.
This publication is published as a double logo standard.

80601-2-30 © IEC:2009 – 5 –
The text of this particular standard is based on the following documents:

FDIS Report on voting
62D/721/FDIS 62D/737/RVD
Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table. In ISO, the standard has been approved by 13

P-members out of 17 having cast a vote.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

– 6 – 80601-2-30 © IEC:2009
The committee has decided that the contents of this particular standard will remain
unchanged until the maintenance result date indicated on the IEC web site 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 National Committees is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised 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 committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication for equipment newly designed and
not earlier than 5 years from the date of publication for equipment already in production.
The contents of the corrigendum of January 2010 have been included in this copy.

80601-2-30 © IEC:2009 – 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 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, this annex does not form part of the requirements of this standard.

– 8 – 80601-2-30 © IEC:2009
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

1)
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This 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 indirect measurement of the BLOOD PRESSURE
without arterial puncture.
NOTE 1 Equipment that performs indirect measurement of the BLOOD PRESSURE without arterial puncture does not
directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for
ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a
this
DETERMINATION.
This standard covers electrically-powered intermittent, indirect measurement 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 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.
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 standard are not covered by specific requirements in this standard
except in 20 1.1 1 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1.
NOTE 2 See also 4.2 of the general standard.
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.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

80601-2-30 © IEC:2009 – 9 –
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of IEC 60601-1 and Clause 2 of this particular standard.

IEC 60601-1-2 is amended by this particular standard. IEC 60601-1-3 does not apply. All

other published collateral standards in the IEC 60601-1 series apply as published.

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 its 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 is 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 standard 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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 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, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses or figures 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 standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
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

– 10 – 80601-2-30 © IEC:2009
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 49.

Clause 2 of the general standard applies, except as follows:

Amendment of the following reference:

IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
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 60601-2-2:2009, 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
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
2)
ISO 81060-2:___ , Non-invasive sphygmomanometers – Part 2: Clinical validation 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, and IEC 60601-2-2:2009 apply, except as follows:
NOTE An index of defined terms is found beginning on page 51.
Addition:
—————————
2)
To be published.
80601-2-30 © IEC:2009 – 11 –
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 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]
201.3.204
CUFF
part of the AUTOMATED SPHYGMOMANOMETER that is wrapped around the limb of the PATIENT
NOTE 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).
[ISO 81060-1:2007, definition 3.5, modified]
201.3.205
DETERMINATION (value)
result of the process of estimating BLOOD PRESSURE by the AUTOMATED SPHYGMOMANOMETER
201.3.206
DIASTOLIC BLOOD PRESSURE (value)
minimum value of the BLOOD PRESSURE as a result of relaxation of the systemic ventricle
NOTE 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.
3)
[IEC 60601-1-11___ , definition 3.2]
—————————
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).

– 12 – 80601-2-30 © IEC:2009
201.3.208
LONG-TERM AUTOMATIC MODE
mode in which a timer, set by the OPERATOR, initiates multiple DETERMINATIONS

201.3.209
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 Because of hydrostatic effects, this value should be determined with the CUFF at the level of the heart.

201.3.210
NEONATAL MODE
mode of AUTOMATED SPHYGMOMANOMETER for use with neonates or infants
NOTE 1 The approximate age range for a newborn (neonate) is from birth to 1 month. [ 10]
NOTE 2 The approximate age range for an infant is from 1 month to 2 years. [10] For the purposes of this
standard, up to 3 years of age are considered infants (see ISO 81060-2, 6.1.3).
NOTE 3 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.
201.3.211
NON-AUTOMATED SPHYGMOMANOMETER
ME EQUIPMENT used for the non-invasive measurement 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 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.
[ISO 81060-1:2007, definition 3.11, modified]
201.3.212
PATIENT SIMULATOR
equipment for simulating the oscillometric CUFF pulses and/or auscultatory signals during
inflation and deflation
NOTE This equipment is not used for testing accuracy but is used in assessing stability of performance.
201.3.213
PNEUMATIC SYSTEM
part of the AUTOMATED SPHYGMOMANOMETER that includes all pressurized and pressure-
controlling components
EXAMPLES CUFF, tubing, connectors, valves, PRESSURE TRANSDUCER and pump.
[ISO 81060-1:2007, definition 3.16, modified]
201.3.214
PRESSURE TRANSDUCER
component that transforms sensed pressure into an electrical signal
201.3.215
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
—————————
4)
Figures in square brackets refer to the Bibliography.

80601-2-30 © IEC:2009 – 13 –
201.3.216
SELF-MEASUREMENT AUTOMATIC MODE

mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated by the OPERATOR and in

which a limited number of DETERMINATIONS are made

201.3.217
* SHORT-TERM AUTOMATIC MODE
mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated by the OPERATOR and in

which repetitive automatic DETERMINATIONS are made rapidly within a specified time period

201.3.218
SYSTOLIC BLOOD PRESSURE (value)
maximum value of the BLOOD PRESSURE as a result of the contraction of the systemic ventricle
NOTE 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 202.6.2.101
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 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
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:

– 14 – 80601-2-30 © IEC:2009
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.
201.7.2.103 * automated sphygmomanometers 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.
201.7.2.104 * automated sphygmomanometers for public use
If the AUTOMATED SPHYGMOMANOMETER is intended for self-use in public areas, it shall be
marked with the following:
– precautions for use, including a statement concerning the need to consult a physician for
interpretation of BLOOD PRESSURE measurements;
– adequate operating instructions;
– this sphygmomanometer complies with IEC 80601-2-30.
EXAMPLE Self-measurement station in a pharmacy, fitness centre, workplace.

80601-2-30 © IEC:2009 – 15 –
201.7.2.105 * 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

201.7.2.106 Disposal
The AUTOMATED SPHYGMOMANOMETER and its parts shall be marked with regard to disposal, as
appropriate, in accordance with national or regional regulations.
5)
NOTE See also IEC 60601-1-9 .
201.7.9.2 Instructions for use
201.7.9.2.1 General
Replacement of the 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:
– for use with neonatal PATIENTS,
– 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;
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:
—————————
5)
IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for basic safety and
essential performance – Collateral standard: Requirements for environmentally conscious design

– 16 – 80601-2-30 © IEC:2009
– regarding the effect of blood flow interference and resulting harmful injury to the PATIENT

caused by continuous CUFF pressure due to connection tubing kinking;

– indicating that too frequent measurements can cause injury to the PATIENT due to blood

flow interference;
– regarding the application of the CUFF over a wound, as this can cause further injury;

– regarding the application of the CUFF and its pressurization on any limb where

intravascular access or therapy, or an arterio-venous (A-V) shunt, is present because of

temporary interference to blood flow and could result in injury to the PATIENT;

– regarding the application of the CUFF and its pressurization on the arm on the side of a

mastectomy;
– regarding the information that pressurization of the CUFF can temporarily cause loss of
function of simultaneously used monitoring ME EQUIPMENT on the same limb;
– regarding the need to check (for example, by observation of the limb concerned) that
operation of the AUTOMATED SPHYGMOMANOMETER does not result in prolonged impairment
of the circulation of the blood of the PATIENT.
201.7.9.2.5 Me equipment description
Addition, after the third dashed item in the first paragraph:
– a description of the operating principles of the AUTOMATED SPHYGMOMANOMETER;
– RATED ranges of the DETERMINATION.
201.7.9.2.9 Operating instructions
Addition:
The instructions for use shall contain the following information:
a) an explanation of the selection of a suitably sized CUFF and the application of the CUFF to
the PATIENT;
b) an explanation of the operating steps needed to obtain accurate routine resting BLOOD
PRESSURE measurements for the condition hypertension [2 0] i n c l ud i n g;
– adjustment of the pressure reduction rate, if applicable,
– PATIENT position in NORMAL USE, including
1) comfortably seated
2) legs uncrossed
3) feet flat on the floor
4) back and arm supported
5) middle of the CUFF at the level of the right atrium of the heart
– a recommendation that the PATIENT relax as much as possible and not talk during the
measurement PROCEDURE,
– a recommendation that 5 min should elapse before the first reading is taken;
– OPERATOR position in NORMAL USE,
c) an explanation that any BLOOD PRESSURE reading can be affected by the measurement
site, the position of the PATIENT (standing, sitting, lying down), exercise, or the PATIENT'S
physiologic condition;
d) details of what the OPERATOR
...