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SIST EN 60601-2-20:2010/A11:2012

(Amendment)

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

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

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.211 of this standard, also 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 the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies safety requirements for INFANT TRANSPORT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information
see IEC 80601-2-35 [1]1);
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].

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
14-Nov-2011
Withdrawal Date
12-Oct-2023
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
13-Oct-2023
Due Date
05-Nov-2023
Completion Date
13-Oct-2023
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
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

Relations

Replaced By
SIST 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 (IEC 60601-2-20:2020)
Effective Date
13-Oct-2020
Amends
SIST EN 60601-2-20:2010 - Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators (IEC 60601-2-20:2009)
Effective Date
29-Jan-2023
Amends
SIST EN 60601-2-20:2010 - Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators (IEC 60601-2-20:2009)
Effective Date
07-Jun-2022
Amends
SIST EN 60601-2-20:2010 - Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators (IEC 60601-2-20:2009)
Effective Date
11-Oct-2011
Revised
SIST EN 60601-2-20:2010/A1:2017 - Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009/A1:2016)
Effective Date
03-Mar-2015

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EN 60601-2-20:2010/A11:2012EN 60601-2-20:2010/A11:2012
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-20:2010/A11:2012
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
SIST EN 60601-2-20:2010/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-20:2010/A11:2012

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

SIST EN 60601-2-20:2010/A11:2012

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
...

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