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SIST EN 60601-2-37:2008/A11:2012

(Amendment)

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of this standard.

Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung

Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons

Medicinska električna oprema - 2-37. del: Posebne varnostne zahteve za ultrazvočno medicinsko diagnostično in nadzorovalno opremo

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ULTRAZVOČNE DIAGNOSTIČNE OPREME, kot je določeno v 201.3.217, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 tega standarda.

General Information

Status
Published
Publication Date
22-Nov-2011
ICS
11.040.55 - Diagnostic equipment
17.140.50 - Electroacoustics
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
14-Nov-2011
Due Date
19-Jan-2012
Completion Date
23-Nov-2011
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
EN 60601-2-37:2008/A11:2011 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Relations

Amends
SIST EN 60601-2-37:2008 - Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Effective Date
11-Oct-2011
Amends
SIST EN 60601-2-37:2008 - Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Effective Date
28-Jan-2023
Revised
oSIST prEN IEC 60601-2-37:2023 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Effective Date
23-Jan-2023

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EN 60601-2-37:2008/A11:2012
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-37:2008/A11:2012
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
XOWUD]YRþQRPHGLFLQVNRGLDJQRVWLþQRLQQDG]RURYDOQRRSUHPR
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die
medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de diagnostic et de surveillance médicaux
à ultrasons
Ta slovenski standard je istoveten z: EN 60601-2-37:2008/A11:2011
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
SIST EN 60601-2-37:2008/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-37:2008/A11:2012

---------------------- Page: 2 ----------------------

SIST EN 60601-2-37:2008/A11:2012

EUROPEAN STANDARD
EN 60601-2-37/A11

NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM

ICS 11.040.55; 17.140.50


English version


Medical electrical equipment -
Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment



Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-37: Exigences particulières pour Teil 2-37: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils de diagnostic et Leistungsmerkmale von
de surveillance médicaux à ultrasons Ultraschallgeräten für die medizinische
Diagnose und Überwachung






This amendment A11 modifies the European Standard EN 60601-2-37:2008; it was approved by CENELEC on
2011-10-01. 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 o
...

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