SIST EN 80601-2-30:2010/A1:2015

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• Status: Withdrawn
• Publication Date: 13-Aug-2015
• Withdrawal Date: 15-Aug-2022
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 29-Jul-2022
• Due Date: 21-Aug-2022
• Completion Date: 16-Aug-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 80601-2-30:2010/A1:2015 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Relations

• Amends: SIST EN 80601-2-30:2010 - 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)
• Effective Date: 01-Sep-2015
• Replaced By: SIST EN IEC 80601-2-30:2019 - 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)
• Effective Date: 28-May-2019
• Replaced By: SIST EN IEC 80601-2-30:2019 - 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)
• Effective Date: 07-Jun-2022
• Amends: SIST EN 80601-2-30:2010 - 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)
• Effective Date: 28-Jan-2023
• Revised: SIST EN IEC 80601-2-30:2019 - 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)
• Effective Date: 02-Feb-2016
• Amends: SIST EN 80601-2-30:2010 - 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)
• Effective Date: 07-Jun-2022

Standards Content (Sample)

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.

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SIST EN 80601-2-30:2010/A1:2015

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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

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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.
2

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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

3

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SIST EN 80601-2-30:2010/A1:2015

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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.

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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
...