EN 60601-1:2006/AC:2014
(Corrigendum)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
2014-10-15: Corrigendum withdrawn as issued by error (see mail from PM (ADF) in dataservice on 2014-10-13).
Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
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
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene lastnosti (IEC 60601-1:2005) - Popravek
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- Withdrawn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
- 08-May-2014
- Technical Committee
- CLC/TC 62 - Electrical equipment in medical practice
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Oct-2014
- Completion Date
- 21-Jan-2026
Relations
- Effective Date
- 29-Jan-2023
EN 60601-1:2006/AC:2014 - 2014-10-15: Corrigendum withdrawn as issued by error (see mail from PM (ADF) in dataservice on 2014-10-13). Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
EN 60601-1:2007/AC:2014 - 2014-10-15: Corrigendum withdrawn as issued by error (see mail from PM (ADF) in dataservice on 2014-10-13). Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
Frequently Asked Questions
EN 60601-1:2006/AC:2014 is a corrigendum published by CLC. Its full title is "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This standard covers: 2014-10-15: Corrigendum withdrawn as issued by error (see mail from PM (ADF) in dataservice on 2014-10-13). Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
2014-10-15: Corrigendum withdrawn as issued by error (see mail from PM (ADF) in dataservice on 2014-10-13). Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
EN 60601-1:2006/AC:2014 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/AC:2014 has the following relationships with other standards: It is inter standard links to 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/AC:2014 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/432. 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/AC:2014 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen LeistungsmerkmaleAppareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentiellesMedical electrical equipment - Part 1: General requirements for basic safety and essential performance11.040.01Medicinska oprema na splošnoMedical equipment in generalICS:Ta slovenski s
...
SLOVENSKI STANDARD
01-julij-2014
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti (IEC 60601-1:2005) - Popravek
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/AC:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/
...
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