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 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: Withdrawn
• Publication Date: 09-Sep-2010
• Withdrawal Date: 31-Aug-2013
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 24-May-2022
• Completion Date: 24-May-2022
• 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 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)

Relations

• Replaces: EN 60601-2-30:2000 - Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
• Effective Date: 28-Jan-2023
• Replaced By: 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
• Effective Date: 02-Feb-2016
• Amended By: 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: 28-Jan-2023

Standards Content (Sample)

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

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
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 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:

- 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).
__________
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
- 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.
___________
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
XA
CODE PRIX
ICS 11.040 ISBN 2-8318-1025-0
– 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.
...