SIST EN IEC 80601-2-30:2019

SLOVENSKI STANDARD
SIST EN IEC 80601-2-30:2019
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
SIST EN IEC 80601-2-30:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80601-2-30:2019

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SIST EN IEC 80601-2-30:2019


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

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SIST EN IEC 80601-2-30:2019
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

2

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SIST EN IEC 80601-2-30:2019
EN IEC 80601-2-30:2019 (E)
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
3

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SIST EN IEC 80601-2-30:2019
EN IEC 80601-2-30:2019 (E)
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

4

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SIST EN IEC 80601-2-30:2019



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



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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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

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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

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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:

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IEC 80601-2-30:2018 © IEC 2018 – 5 –
1
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.

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– "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.

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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.

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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
2
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.

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201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral st
...