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EN 60601-2-37:2008/A11:2011

(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

D139/C149: BT approved the modified Annex ZZ for EN 60601-2-37:2008
2021: CLC legacy converted by DCLab NISOSTS

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
13-Oct-2011
Withdrawal Date
30-Sep-2014
ICS
11.040.55 - Diagnostic equipment
17.140.50 - Electroacoustics
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
CLC/TC 62 - Electrical equipment in medical practice
Current Stage
6060 - Document made available - Publishing
Start Date
14-Oct-2011
Completion Date
14-Oct-2011
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
SIST EN 60601-2-37:2008/A11:2012 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Relations

Amends
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
EN IEC 60601-2-37:2024 - 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-Aug-2022

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


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

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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