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

NEW!IEC 80601-2-30:2018 is available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-30:2018 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. 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. 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. 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: a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , 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.

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

NEW!IEC 80601-2-30:2018 est disponible sous forme de IEC 80601-2-30:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L’IEC 80601-2-30:2018 s'applique à la sécurité de base et aux performances essentielles des sphygmomanomètres automatiques, ci-après dénommés appareils EM, qui, au moyen d'un brassard gonflable, sont utilisés pour l'estimation indirecte non continue de la pression artérielle sans ponction artérielle. Le présent document spécifie les exigences pour la sécurité de base et les performances essentielles de ces appareils EM et leurs accessoires, y compris les exigences relatives à l'exactitude de la détermination de la pression artérielle. Le présent document couvre les appareils EM automatiques à énergie électrique utilisés pour l'estimation indirecte intermittente de la pression artérielle sans ponction artérielle, y compris les moniteurs de pression artérielle pour l'environnement des soins à domicile. Les exigences relatives aux appareils EM d'estimation indirecte de la pression artérielle sans ponction artérielle comportant un transducteur de pression à énergie électrique et/ou des affichages utilisés conjointement avec un stéthoscope ou autres méthodes manuelles de détermination de la pression artérielle (sphygmomanomètres non automatiques) sont spécifiées dans l'ISO 81060-1. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si tel n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas. Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11 et 201.105.3.3, ainsi que 7.2.13 et 8.4.1 de l'IEC 60601-1:2005. Cette deuxième édition annule et remplace la première édition parue en 2009 et son Amendement 1:2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) alignement avec l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601 1 8:2006/AMD1:2012, et avec l'IEC 60601-1-2:2014 et l'IEC 60601-1-11:2015; b) référence à l'IEC 60601-1-10:2007 et à l'IEC 60601-1-12; c) modification d'un connecteur brassard-sphygmomanomètre accessible à l'operateur non compatible avec la série ISO 594 en un connecteur compatible avec la série ISO 80369; d) ajout d'exigences supplémentaires relatives aux sphygmomanomètres à usage autonome dans les zones publiques; e) ajout d'une liste de fonctions principales de service.

Medicinska električna oprema - 2-30. del: Posebne zahteve za osnovno varnost in bistvene lastnosti avtomatiziranih neinvazivnih sfigmomanometrov (IEC 80601-2-30:2018)

Ta del mednarodnega standarda 80601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI AVTOMATIZIRANIH SFIGMOMANOMETROV (v nadaljevanju »ELEKTROMEDICINSKA OPREMA«), ki se s pomočjo napihljive MANŠETE uporabljajo za občasno posredno oceno KRVNEGA TALKA brez vboda v arterijo.
OPOMBA 1: Oprema, ki izvaja posredno DOLOČANJE KRVNEGA TLAKA brez vboda v arterijo, ne meri KRVNEGA TLAKA neposredno. KRVNI TLAK samo oceni.
Ta dokument določa zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI te ELEKTROMEDICINSKE OPREME in njenih PRIPOMOČKOV, vključno z zahtevami za natančnost DOLOČANJA.
Ta dokument zajema avtomatsko električno ELEKTROMEDICINSKO OPREMO, ki se uporablja za občasno posredno oceno KRVNEGA TLAKA brez vboda v arterijo, vključno z monitorji KRVNEGA TLAKA za DOMAČO ZDRAVSTVENO OSKRBO. Zahteve za ELEKTROMEDICINSKO OPREMO za posredno oceno KRVNEGA TLAKA brez vboda v arterijo z električnim PRENOSNIKOM TLAKA in/ali prikazovalniki, ki se uporabljajo skupaj s stetoskopi ali z drugimi ročnimi metodami za določanje KRVNEGA TLAKA (NEAVTOMATIZIRANI SFIGMOMANOMETRI), so določene v dokumentu ISO 81060-1 [2].
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME ali SISTEMOV, ki spadajo na področje tega dokumenta, razen v točkah 201.11 in 201.105.3.3 ter v 7.2.13 in 8.4.1 standarda IEC 60601-1:2005.

General Information

• Status: Published
• Publication Date: 23-May-2019
• Withdrawal Date: 23-May-2022
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-May-2019
• Completion Date: 24-May-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: 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)

Relations

• Replaces: 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
• Effective Date: 07-Jun-2022
• Replaces: 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
• Effective Date: 02-Feb-2016

Standards Content (Sample)

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

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

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

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
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
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

– 2 – IEC 80601-2-30:2018 © IEC 2018
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

IEC 80601-2-30:2018 © IEC 2018 – 3 –
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 SING
...