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SIST EN 60601-2-39:2008/A11:2012

(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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. 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 the general standard.

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
30-Nov-2011
Withdrawal Date
15-Aug-2022
ICS
11.040.99 - Other medical equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
29-Jul-2022
Due Date
21-Aug-2022
Completion Date
16-Aug-2022
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
EN 60601-2-39:2008/A11:2011 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Relations

Amends
SIST 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
11-Oct-2011
Replaced By
SIST EN IEC 60601-2-39:2019 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018)
Effective Date
28-May-2019
Revised
SIST EN IEC 60601-2-39:2019 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018)
Effective Date
23-Aug-2016
Amends
SIST 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
Amends
SIST 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
07-Jun-2022

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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
SIST EN 60601-2-39:2008/A11:2012
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
SIST EN 60601-2-39:2008/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-39:2008/A11:2012

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

SIST EN 60601-2-39:2008/A11:2012

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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