EN 60601-1:2006/A11:2011
(Amendment)Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
D139/C149: BT approved the modified Annex ZZ for EN 60601-1:2006 * Obsolete due to EN 60601-1:2006/A1:2013 publication
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
Električna medicinska oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTRIČNE MEDICINSKE OPREME in ELEKTRIČNIH MEDICINSKIH SISTEMOV, v nadaljevanju ME OPREMA in ME SISTEMI. 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 in ME SISTEMOV v okviru področja uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1. Ta standard se lahko uporablja tudi za opremo, ki se uporablja za kompenziranje ali lajšanje bolezni, poškodbe ali prizadetosti. Diagnostična oprema in vitro, ki ni zajeta z definicijo ME OPREME, je zajeta s serijo 2 IEC 61010. Ta standard ne velja za vsadne dele aktivnih medicinskih vsadkov, ki so zajeti v ISO 14708-1. Ta EN 60601-1:2006 je bil v primerjavi z EN 60601-1:1990 precej preurejen. Zahteve v električnem delu so bile nadalje usklajene s tistimi za opremo informacijske opreme, ki jih zajema EN 60950-1, dodana je bila tudi zahteva za vključitev PROCESA ZA OBVLADOVANJE TVEGANJ. Za razširjen opis te revizije glej točko A.3.
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- Withdrawn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
- 28-Oct-2013
- Completion Date
- 21-Jan-2026
Relations
- Effective Date
- 28-Jan-2023
- Effective Date
- 28-Jan-2023
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Frequently Asked Questions
EN 60601-1:2006/A11:2011 is a amendment published by CLC. Its full title is "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This standard covers: D139/C149: BT approved the modified Annex ZZ for EN 60601-1:2006 * Obsolete due to EN 60601-1:2006/A1:2013 publication
D139/C149: BT approved the modified Annex ZZ for EN 60601-1:2006 * Obsolete due to EN 60601-1:2006/A1:2013 publication
EN 60601-1:2006/A11:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040 - Medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 60601-1:2006/A11:2011 has the following relationships with other standards: It is inter standard links to EN 60601-1:2006/A1:2013, EN 60601-1:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 60601-1:2006/A11:2011 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 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 60601-1:2006/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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Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles
Ta slovenski standard je istoveten z: EN 60601-1:2006/A11:2011
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60601-1/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
ICS 11.040
English version
Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 1: Exigences générales pour la Teil 1: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles Leistungsmerkmale
This amendment A11 modifies the European Standard EN 60601-1:2006; 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 members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B -
...
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