EN 60601-2-20:2009/A11:2011

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

D139/C149: BT approved the modified Annex ZZ for EN 60601-2-20:2009

Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Tranportinkubatoren

Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés

Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in bistvene lastnosti prenosnih inkubatorjev

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI opreme PRENOSNIH INKUBATORJEV ZA DOJENČKE, kot so opredeljene v točki 201.3.211 tega standarda, imenovano tudi ME OPREMA. Če je točka ali podtočka izrecno namenjena uporabi zgolj za ME OPREMO ali ME SISTEME, bosta naslov in vsebina te točke ali podtočke to navedla. Če ni tako, se točka ali podtočka smotrno uporablja tako za ME OPREMO kot ME SISTEME. NEVARNOSTI, ki so v okviru tega standarda povezane s predvideno fiziološko funkcijo ME OPREME ali ME SISTEMOV, niso zajete v posebnih zahtevah tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glej tudi točko 4.2 splošnega standarda. Ta posebni standard opredeljuje varnostne zahteva za PRENOSNE INKUBATORJE ZA DOJENČKE, vendar za nadomestne metode ugotavljanja skladnosti s posebno točko z dokazovanjem enake stopnje varnosti ne velja, da niso skladne, če je PROIZVAJALEC dokazal v svojem DOKUMENTU O OBVLADOVANJU TVEGANJA, da je bilo za TVEGANJE, ki ga predstavljajo NEVARNOSTI, ugotovljeno, da ni na sprejemljivi ravni v primerjavi z koristjo zdravljenja, ki ga zagotavlja naprava.
Ta posebni standard ne velja za:
– naprave, ki oddajajo toploto v medicinske namene preko ODEJ, BLAZIN ali ŽIMNIC; za informacije glej IEC 80601-2-35 [1];
– INKUBATORJE ZA DOJENČKE, ki niso PRENOSNI INKUBATORJI ZA DOJENČKE; za informacije glej IEC 60601-2-19 [2];
– SEVALNE GRELNIKE ZA DOJENČKE; za informacije glej IEC 60601-2-21 [3];
– FOTOTERAPIJO ZA DOJENČKE; za informacije glej IEC 60601-2-50 [4].

General Information

• Status: Withdrawn
• Publication Date: 13-Oct-2011
• Withdrawal Date: 30-Sep-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 07-Oct-2023
• Completion Date: 07-Oct-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 60601-2-20:2010/A11:2012 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

Relations

• Replaced By: EN IEC 60601-2-20:2020 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• Effective Date: 13-Oct-2020
• Amends: EN 60601-2-20:2009 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• Effective Date: 29-Jan-2023
• Revised: EN 60601-2-20:2009/A1:2016 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
• Effective Date: 03-Mar-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLSUHQRVQLKLQNXEDWRUMHY
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and
essential performance of infant transport incubators
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Tranportinkubatoren
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs de transport pour nouveau-nés
Ta slovenski standard je istoveten z: EN 60601-2-20:2009/A11:2011
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-20/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
ICS 11.040.10
English version
Medical electrical equipment -
Part 2-20: Particular requirements for the basic safety and essential
performance of infant transport incubators

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-20: Exigences particulières pour Teil 2-20: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des incubateurs de transport Leistungsmerkmale von
pour nouveau-nés Tranportinkubatoren

This amendment A11 modifies the European Standard EN 60601-2-20:2009; 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 offici
...