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EN 60601-2-39:2008/A11:2011

(Amendment)

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

D139/C149: BT approved the modified Annex ZZ for EN 60601-2-39:2008

Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten

Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale

Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ME OPREME ZA TREBUŠNO DIALIZO, kot je določeno v 201.3.208, v nadaljevanju PD OPREMA. Velja za PD OPREMO, ki jo uporablja medicinsko osebje ali je pod nadzorom medicinskih strokovnjakov, vključno s PD OPREMO, ki jo upravlja BOLNIK, ne glede na to, ali je PD OPREMA uporabljena v bolniškem ali domačem okolju. 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 splošnega standarda.

General Information

Status
Withdrawn
Publication Date
13-Oct-2011
Withdrawal Date
30-Sep-2014
ICS
11.040.99 - Other medical equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
CLC/TC 62 - Electrical equipment in medical practice
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
Ref Project
SIST EN 60601-2-39:2008/A11:2012 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Relations

Replaced By
EN IEC 60601-2-39:2019 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Effective Date
23-Jan-2023
Amends
EN 60601-2-39:2008 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Effective Date
28-Jan-2023

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EN 60601-2-39:2008/A11:2012EN 60601-2-39:2008/A11:2012
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EN 60601-2-39:2008/A11:2012
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Standards Content (Sample)


SLOVENSKI STANDARD
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DWUHEXãQRGLDOL]R
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de dialyse péritonéale
Ta slovenski standard je istoveten z: EN 60601-2-39:2008/A11:2011
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-39/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
ICS 11.040.99
English version
Medical electrical equipment -
Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-39: Exigences particulières pour Teil 2-39: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils de dialyse Leistungsmerkmale von Peritoneal-
péritonéale Dialyse-Geräten
This amendment A11 modifies the European Standard EN 60601-2-39:2008; 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 own language and notified to the
CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC
...

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