EN 60601-2-50:2009/A11:2011
(Amendment)Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
2020-11-04-JO - CLC/TC 62 Decision 02/2019 in Oslo 2019 to decouple work items from MDD and AIMD for projects that do not yet have an Annex ZZ approved by the HAS consultant.. Following exchange with TC leadership and given that the transition of MDD ends in May 2021, the TC will rather focus on the citation of their standards under the MDR. The link to MDD and M/467 removed
2020-11-04- offered for citation in 2017 but never cited
D139/C149: BT approved the modified Annex ZZ for EN 60601-2-50:2009
2021: CLC legacy converted by DCLab NISOSTS
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
Appareils électromédicaux - Partie 2-50: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés
Medicinska električna oprema - 2-50. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za otroško fototerapevtsko opremo
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OTROŠKE FOTOTERAPEVTSKE OPREME, kot je določeno v 201.3.203 tega standarda, prav tako imenovanih 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 splošnega standarda. OPOMBA: Prav tako glej 4.2 splošnega standarda. Ta določen standard določa varnostne zahteve za OTROŠKO FOTOTERAPEVTSKO OPREMO, vendar alternativne metode skladnosti z določeno točko z dokazovanjem enakovredne varnosti ne bodo ocenjene kot neskladne, če je PROIZVAJALEC predstavil v svojem DOKUMENTU OBVLADOVANJA TVEGANJA, da je TVEGANJE, predstavljeno z NEVARNOSTJO, sprejemljive stopnje v primerjavi s koristjo terapije naprave.
Ta konkretni standard ne velja za:
- naprave, ki dovajajo toplote prek ODEJ, BLAZIN ali POSTELJNIH VLOŽKOV pri medicinski uporabi, za informacije
glej IEC 80601-2-35;
- OTROŠKE INKUBATORJE; za informacije glej IEC 60601-2-19;
- PRENOSNE INKUBATORJE; za informacije glej IEC 60601-2-20;
- OTROŠKE SEVALNE OGREVALNIKE; za informacije glej IEC 60601-2-21.
General Information
- Status
- Withdrawn
- Publication Date
- 13-Oct-2011
- Withdrawal Date
- 30-Sep-2014
- 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
- 16-Jul-2024
- Completion Date
- 16-Jul-2024
Relations
- Effective Date
- 23-Jan-2023
- Effective Date
- 28-Jan-2023
- Effective Date
- 10-Mar-2015
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Frequently Asked Questions
EN 60601-2-50:2009/A11:2011 is a amendment published by CLC. Its full title is "Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment". This standard covers: 2020-11-04-JO - CLC/TC 62 Decision 02/2019 in Oslo 2019 to decouple work items from MDD and AIMD for projects that do not yet have an Annex ZZ approved by the HAS consultant.. Following exchange with TC leadership and given that the transition of MDD ends in May 2021, the TC will rather focus on the citation of their standards under the MDR. The link to MDD and M/467 removed 2020-11-04- offered for citation in 2017 but never cited D139/C149: BT approved the modified Annex ZZ for EN 60601-2-50:2009 2021: CLC legacy converted by DCLab NISOSTS
2020-11-04-JO - CLC/TC 62 Decision 02/2019 in Oslo 2019 to decouple work items from MDD and AIMD for projects that do not yet have an Annex ZZ approved by the HAS consultant.. Following exchange with TC leadership and given that the transition of MDD ends in May 2021, the TC will rather focus on the citation of their standards under the MDR. The link to MDD and M/467 removed 2020-11-04- offered for citation in 2017 but never cited D139/C149: BT approved the modified Annex ZZ for EN 60601-2-50:2009 2021: CLC legacy converted by DCLab NISOSTS
EN 60601-2-50:2009/A11:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.60 - Therapy equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 60601-2-50:2009/A11:2011 has the following relationships with other standards: It is inter standard links to EN IEC 60601-2-50:2021, EN 60601-2-50:2009, EN 60601-2-50:2009/A1:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 60601-2-50:2009/A11:2011 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 60601-2-50:2009/A11:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
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ELVWYHQHODVWQRVWL]DRWURãNRIRWRWHUDSHYWVNRRSUHPR
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
Appareils électromédicaux - Partie 2-50: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de photothérapie pour nouveau-nés
Ta slovenski standard je istoveten z: EN 60601-2-50:2009/A11:2011
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60601-2-50/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
ICS 11.040.60
English version
Medical electrical equipment -
Part 2-50: Particular requirements for the basic safety and essential
performance of infant phototherapy equipment
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-50: Exigences particulières pour Teil 2-50: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils de Leistungsmerkmale von Säuglings-
photothérapie pour nouveau-nés Phototherapiegeräten
This amendment A11 modifies the European Standard EN 60601-2-50:2009; 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 official versions.
CENELEC memb
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