Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

2013-06-03 - Negative assessment

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

Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov - Dopolnilo A1

General Information

Status
Published
Publication Date
21-May-2015
Current Stage
6060 - Document made available
Due Date
22-May-2015
Completion Date
22-May-2015

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EN 80601-2-30:2010/A1:2015
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SLOVENSKI STANDARD
SIST EN 80601-2-30:2010/A1:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLDYWRPDWL]LUDQLKQHLQYD]LYQLKVILJPRPDQRPHWURY'RSROQLOR$

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and

essential performance of automated non-invasive sphygmomanometers

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
Ta slovenski standard je istoveten z: EN 80601-2-30:2010/A1:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 80601-2-30:2010/A1:2015 en

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

---------------------- Page: 1 ----------------------
SIST EN 80601-2-30:2010/A1:2015
---------------------- Page: 2 ----------------------
SIST EN 80601-2-30:2010/A1:2015
EUROPEAN STANDARD EN 80601-2-30:2010/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040
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/A1:2013)

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 80601-2-30:2009/A1:2013) (IEC 80601-2-30:2009/A1:2013)

This amendment A1 modifies the European Standard EN 80601-2-30:2010; it was approved by CENELEC on 2015-04-14. CENELEC

members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, 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: Avenue Marnix 17, B-1000 Brussels

© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 80601-2-30:2010/A1:2015 E
---------------------- Page: 3 ----------------------
SIST EN 80601-2-30:2010/A1:2015
EN 80601-2-30:2010/A1:2015
Foreword
The text of document 62D/1072/FDIS, future IEC 80601-2-30:2009/A1, prepared by

SC 62D "Electrical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted

to the IEC-CENELEC parallel vote and approved by CENELEC as EN 80601-2-30:2010/A1:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
standards conflicting with the
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such

patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission

and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in

EN 80601-2-30:2010.
Endorsement notice

The text of the International Standard IEC 80601-2-30:2009/A1:2013 was approved by CENELEC as

a European Standard without any modification.
---------------------- Page: 4 ----------------------
SIST EN 80601-2-30:2010/A1:2015
EN 80601-2-30:2010/A1:2015
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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
Modifications in Annex ZA of EN 80601-2-30:2010:
Publication Year Title EN/HD Year

Add after the existing reference to IEC 60601-1-2:2007, the following new references:

IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Part 1-6: General requirements for basic
safety and essential performance -
Collateral standard: Usability
+A1 2013 +A1 2015
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral Standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
+A1 2012 +A1 2013
+A1/AC 2014

Add to the list of references under the existing instruction "Addition:" the following

new references:
IEC 60601-1-11 2010 Medical electrical equipment - EN 60601-1-11 2010
Part 1-11: General requirements for basic
safety and essential performance -
Collateral standard: Requirements for
medical electrical equipment and medical
electrical systems used in the home
healthcare environment
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
Replace the existing reference to ISO 81060-2 by the following:
ISO 81060-2 2013 Non-invasive sphygmomanometers - - -
Part 2: Clinical investigation of automated
measurement type
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SIST EN 80601-2-30:2010/A1:2015
---------------------- Page: 6 ----------------------
SIST EN 80601-2-30:2010/A1:2015
IEC 80601-2-30
Edition 1.0 2013-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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 L
ICS 11.040 ISBN 978-2-8322-1003-1

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.

---------------------- Page: 7 ----------------------
SIST EN 80601-2-30:2010/A1:2015
– 2 – 80601-2-30 Amend.1 © IEC:2013
FOREWORD

This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC

technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1072/FDIS 62D/1079/RVD

Full information on the voting for the approval of this amendment 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.

The committee has decided that the contents of this amendment and the base publication will

remain unchanged until the stability 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 and Member Bodies 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 or ISO 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

_____________
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SIST EN 80601-2-30:2010/A1:2015
80601-2-30 Amend.1 © IEC:2013 – 3 –
INTRODUCTION TO THE AMENDMENT

This amendment deals primarily with editorial corrections and clarifications, clarifies

requirements for operation in the loss of SUPPLY MAINS and references new and updated

collateral standards.

To meet needs for change which were identified by users of this particular standard, it was

necessary to amend the standard before the previously approved maintenance cycle date.

201.1 Scope, object and related standards
Add at the end of footnote 1), “including Amendment 1:2012”.
201.1.1 Scope
In the first paragraph, replace “intermittent” with “non-continuous”.
201.2 Normative references

Replace the initial instruction concerning amendment of the reference to IEC 60601-1-2 by the

same instruction in the plural form, as follows:
Amendment of the following references:

Add, after the existing reference to IEC 60601-1-2:2007, the following new references:

IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic

safety and essential performance – Collateral standard: Usability
Amendment 1:2013

IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical electrical systems

Amendment 1:2012

Add to the list of references under the existing instruction "Addition:" the following new

references:

IEC 60601-1-11:2010, Medical electrical equipment – Part 1-11: General requirements for

basic safety and essential performance – Collateral standard: Requirements for medical

electrical equipment and medical electrical systems used in the home healthcare environment

IEC 62366:2007, Medical devices – Application of usability engineering to medical devices

Replace the existing reference to ISO 81060-2 by the following:

ISO 81060-2:2013, Non-invasive sphygmomanometers – Part 2: Clinical investigation of

automated measurement type
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SIST EN 80601-2-30:2010/A1:2015
– 4 – 80601-2-30 Amend.1 © IEC:2013
201.3 Terms and definitions
Replace the existing first paragraph with the following:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-1-8:2006+A1:2012, and
IEC 60601-2-2:2009 apply, except as follows:
201.3.207
HOME HEALTHCARE ENVIRONMENT
Replace the existing definition with the following:

dwelling place in which a PATIENT lives or other places where PATIENTS are present, 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 emergency

medical services.

NOTE 2 For the purpose of this particular standard, nursing homes are considered the HOME HEALTHCARE

ENVIRONMENT.

NOTE 3 Other places where PATIENTS are present include the outdoor environment and in vehicles.

EXAMPLES In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.

[SOURCE: IEC 60601-1-11:2010, definition 3.2]
201.3.216
SELF-MEASUREMENT AUTOMATIC MODE
Replace the existing definition with the following:

mode of AUTOMATED SPHYGMOMANOMETER that is manually initiated and overseen by the

OPERATOR and in which a limited number of repeated DETERMINATIONS are made over a limited

period
201.3.217
SHORT-TERM AUTOMATIC MODE
Replace the existing definition with the following:

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

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

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements

Replace, in the third row, the phrase "Limits of the change in the error" with "Reproducibility".

201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.102 Automated sphygmomanometers for home healthcare environment
Replace the existing title and text of this subclause by the following:
201.7.2.102 AUTOMATED SPHYGMOMANOMETERS for the HOME HEALTHCARE ENVIRONMENT
Vacant.
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SIST EN 80601-2-30:2010/A1:2015
80601-2-30 Amend.1 © IEC:2013 – 5 –
201.7.9.2.13 Maintenance
Replace in t
...

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