EN 60601-2-34:2014

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.

Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-Überwachungsgeräten

Appareils électromédicaux - Partie 2-34: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance de la pression sanguine prélevée directement

La CEI 60601-2-34:2011 concerne la sécurité de base et les performances essentielles pour les appareils de surveillance de la pression sanguine prélevée directement. Elle modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. La troisième édition de CEI 60601-2-34 annule et remplace la deuxième édition publiée en 2001et constitue une révision technique pour l'alignement structurel à l'édition 2005 de la CEI 60601-1. La CEI 60601-2-34 s'applique à la sécurité de base et aux performances essentielles des appareils de surveillance de la pression sanguine prélevée directement. Cette norme particulière ne s'applique pas aux tubes et aiguilles de cathéter, aux connecteurs Luer, et aux prises et panneaux de prises connectés. Cette norme ne s'applique pas non plus aux appareils de surveillance de la pression sanguine prélevée indirectement.

Medicinska električna oprema - 2-34. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za invazivno nadzorovanje krvnega tlaka (IEC 60601-2-34:2011)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME ZA INVAZIVNO NADZOROVANJE KRVNEGA TLAKA, kot je določeno v 201.3.63, v nadaljevanju: ELEKTROMEDICINSKA OPREMA. Ta standard ne velja za katetrske cevke, katetrske igle, nastavke »Luer-lock«, pipe in mize s pipami, ki so povezane z DOME. Ta standard ne zajema OPREME ZA NEINVAZIVNO NADZOROVANJE KRVNEGA TLAKA.

General Information

• Status: Published
• Publication Date: 26-Jun-2014
• Withdrawal Date: 26-Jun-2017
• ICS: 11.040.55 - Diagnostic 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: 6060 - Document made available - Publishing
• Start Date: 27-Jun-2014
• Completion Date: 27-Jun-2014
• 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 60601-2-34:2014 - Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

Relations

• Replaces: EN 60601-2-34:2000 - Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
• Effective Date: 29-Jan-2023
• Revised: prEN IEC 60601-2-34:2022 - Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
• Effective Date: 26-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-34:2014
01-september-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DLQYD]LYQRQDG]RURYDQMHNUYQHJDWODND,(&

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and
essential performance of invasive blood pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit
einschließlich wesentlicher Leistungsmerkmale, von invasiven Blutdruck-
Überwachungsgeräten
Appareils électromédicaux - Partie 2-34: Règles particulières de sécurité de base et de
performances essentielles pour les appareils de surveillance de la pression sanguine
prélevée directement
Ta slovenski standard je istoveten z: EN 60601-2-34:2014
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-34:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-34:2014

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SIST EN 60601-2-34:2014


EUROPEAN STANDARD EN 60601-2-34

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2014
ICS 11.040.55 Supersedes EN 60601-2-34:2000
English Version
Medical electrical equipment - Part 2-34: Particular requirements
for the basic safety and essential performance of invasive blood
pressure monitoring equipment
(IEC 60601-2-34:2011)
Appareils électromédicaux - Partie 2-34: Exigences Medizinische elektrische Geräte - Teil 2-34: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance de la pression wesentlichen Leistungsmerkmale von invasiven Blutdruck-
sanguine prélevée directement Überwachungsgeräten
(CEI 60601-2-34:2011) (IEC 60601-2-34:2011)
This European Standard was approved by CENELEC on 2011-05-16. 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, 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
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-34 E

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SIST EN 60601-2-34:2014
EN 60601-2-34:2014 - 2 -
Foreword
The text of document 62D/906/FDIS, future edition 3 of IEC 60601-2-34, 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 60601-2-34:2014.
The following dates are fixed:
(dop) 2014-12-27
• 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) 2017-06-27
standards conflicting with the
document have to be withdrawn

This document supersedes EN 60601-2-34:2000.

EN 60601-2-34:2014 was revised to align structurally with EN 60601-1:2006.

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.);
– “sub
...