EN 80601-2-30:2010

SLOVENSKI STANDARD
01-december-2010
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Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and
essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-
30:2009 + corrigendum Jan. 2010)
Medizinische elektrische Geräte - Teil 2-30: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von nicht-invasiven
Sphygmomanometern von automatisierten Typ (IEC 80601-2-30:2009 + corrigendum
Jan. 2010)
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base
et les performances essentielles de sphygmomanomètres non invasifs automatiques
(CEI 80601-2-30:2009 + corrigendum Jan. 2010)
Ta slovenski standard je istoveten z: EN 80601-2-30:2010
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 80601-2-30
NORME EUROPÉENNE
September 2010
EUROPÄISCHE NORM
ICS 11.040 Supersedes EN 60601-2-30:2000

English version
Medical electrical equipment -
Part 2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
(IEC 80601-2-30:2009 + corrigendum Jan. 2010)

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-30: Exigences particulières Teil 2-30: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
de sphygmomanomètres non invasifs von nicht-invasiven Sphygmomanometern
automatiques von automatisierten Typ
(CEI 80601-2-30:2009 + corrigendum Jan. (IEC 80601-2-30:2009 + corrigendum Jan.
2010) 2010)
This European Standard was approved by CENELEC on 2010-09-01. 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 Central Secretariat 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 Central Secretariat 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 80601-2-30:2010 E
Foreword
The text of document 62D/721/FDIS, future edition 1 of IEC 80601-2-30, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, and SC 3, Lung
ventilators and related equipment, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted
to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 80601-2-30 on 2010-09-01.
This European Standard supersedes EN 60601-2-30:2000.
EN 60601-1:2006. 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-06-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-09-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
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:

- 3 - EN 80601-2-30:2010
− “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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 80601-2-30:2009 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:
[1] ISO 9919:2005 NOTE  Harmonized as EN ISO 9919:2005 (not modified).
[3] ISO 21647:2004 NOTE  Harmonized as EN ISO 21647:2004 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace the reference to IEC 60601-1-2 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) 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 - EN 60068-2-27 2009
Part 2-27: Tests - Test Ea and guidance:
Shock
IEC 60068-2-31 2008 Environmental testing - EN 60068-2-31 2008
Part 2-31: Tests - Test Ec: Rough handling
shocks, primarily for equipment-type
specimens
IEC 60068-2-64 2008 Environmental testing - EN 60068-2-64 2008
Part 2-64: Tests - Test Fh: Vibration,
broadband random and guidance
IEC 60601-2-2 2009 Medical electrical equipment - EN 60601-2-2 2009
Part 2-2: Particular requirements for 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 EN 20594-1 1993
syringes, needles and certain other medical
equipment -
Part 1: General requirements
ISO 594-2 1991 Conical fittings with a 6 % (Luer) taper for - -
syringes, needles and certain other medical
equipment -
Part 2: Lock fittings
ISO 81060-2 2009 Non-invasive sphygmomanometers - - -
Part 2: Clinical validation of automated
measurement type
- 5 - EN 80601-2-30:2010
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC with the exception of
ERs 3, 4, 7.1 and 12.1.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
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 2-8318-1025-0
– 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
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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 SPHYGMOMA
...