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 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It 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. 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.

Medizinische elektrische Geräte – Teil 2-30: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven Blutdruckmessgeräten

Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles de sphygmomanomètres non invasifs automatiques

La CEI 80601-2-30:2009 s'applique à la sécurité de base et aux performances essentielles des sphygmomanomètres automatiques qui, au moyen d'un brassard gonflable, sont utilisés pour la mesure indirecte intermittente de la pression artérielle sans ponction artérielle. Elle couvre les appareils em à énergie électrique de mesure indirecte intermittente de la pression artérielle sans ponction artérielle, comportant des méthodes automatiques pour l'estimation de la pression artérielle, y compris les moniteurs de pression artérielle pour l'environnement des soins à domicile. Cette première édition de la CEI 80601-2-30 annule et remplace la deuxième édition de la CEI 60601-2-30, publiée en 1999. La présente édition constitue une révision technique de grande ampleur et permet un alignement avec la troisième édition de la CEI 60601-1. Les changements techniques spécifiques incluent: l'extension du domaine d'application de manière à inclure tous les sphygmomanomètres automatiques, y compris ceux avec lesquels le patient est l'opérateur, l'identification des performances essentielles, les nouvelles exigences en matière de validation clinique, les exigences supplémentaires relatives à la résistance mécanique et l'interdiction de l'usage des connecteurs de type Luer accessibles à l'opérateur dans le système pneumatique.

Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov (IEC 80601-2-30:2009 + popravek Jan. 2010)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI AVTOMATIZIRANIH SFIGMOMANOMETROV, v nadaljevanju ME OPREMA, ki se s pomočjo napihljivih manšet uporabljajo za posredno merjenje KRVNEGA TLAKA brez punktiranja arterije. Ta standard določa zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI te ME OPREME ter njenih DODATKOV, vključno z zahtevami za točnost UGOTOVITVE. Ta standard zajema električno gnano, prekinjeno, posredno meritev KRVNEGA TLAKA brez punktiranja arterije, ME OPREMO brez avtomatičnih metod za ugotavljanje KRVNEGA TLAKA, vključno z merilci KRVNEGA TLAKA za DOMAČE ZDRAVSTVENO OKOLJE.  Zahteve za posredno merjenje KRVNEGA TLAKA brez punktiranja arterije za ME OPREMO z električno gnanim PRETVORNIKOM TLAKA in/ali prikazovalniki, uporabljenimi skupaj s stetoskopom ali drugimi ročnimi metodami ugotavljanja KRVNEGA TLAKA (NEAVTOMATSKI SFIGMOMANOMETRI), so določene v dokumentu ISO 81060-1. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV znotraj področja uporabe tega standarda, niso zajete z posebnimi zahtevami tega standarda, razen v točkah 201.11 in 201.105.3.3 kot tudi 7.2.13 in 8.4.1 IEC 60601-1.

General Information

Status
Published
Publication Date
09-Sep-2010
Current Stage
6060 - Document made available
Due Date
10-Sep-2010
Completion Date
10-Sep-2010

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SLOVENSKI STANDARD
SIST EN 80601-2-30:2010
01-december-2010
1DGRPHãþD
SIST EN 60601-2-30:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLDYWRPDWL]LUDQLKQHLQYD]LYQLKVILJPRPDQRPHWURY ,(&
SRSUDYHN-DQ

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
SIST EN 80601-2-30:2010 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 80601-2-30:2010
---------------------- Page: 2 ----------------------
SIST EN 80601-2-30:2010
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
---------------------- Page: 3 ----------------------
SIST EN 80601-2-30:2010
EN 80601-2-30:2010 - 2 -
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 80601-2-30:2010 constitutes a major technical revision as well as an alignment with

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:
---------------------- Page: 4 ----------------------
SIST EN 80601-2-30:2010
- 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).
__________
---------------------- Page: 5 ----------------------
SIST EN 80601-2-30:2010
EN 80601-2-30:2010 - 4 -
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
---------------------- Page: 6 ----------------------
SIST EN 80601-2-30:2010
- 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.
___________
---------------------- Page: 7 ----------------------
SIST EN 80601-2-30:2010
---------------------- Page: 8 ----------------------
SIST EN 80601-2-30:2010
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
CODE PRIX
ICS 11.040 ISBN 2-8318-1025-0
---------------------- Page: 9 ----------------------
SIST EN 80601-2-30:2010
– 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

---------------------- Page: 10 ----------------------
SIST EN 80601-2-30:2010
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

---------------------- Page: 11 ----------------------
SIST EN 80601-2-30:2010
– 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.
---------------------- Page: 12 ----------------------
SIST EN 80601-2-30:2010
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.
---------------------- Page: 13 ----------------------
SIST EN 80601-2-30:2010
– 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.
---------------------- Page: 14 ----------------------
SIST EN 80601-2-30:2010
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.
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SIST EN 80601-2-30:2010
– 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
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 subcl
...

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