SIST EN 60601-1:2007/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
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
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Frequently Asked Questions
SIST EN 60601-1:2007/AC:2014 is a corrigendum published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance". This standard covers: Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
Origin: following BT147/DG9302/DV, change of the DOW of EN 60601-1:2006 from 2018-12-24 to 2012-06-01.
SIST EN 60601-1:2007/AC:2014 is classified under the following ICS (International Classification for Standards) categories: 11.040.01 - Medical equipment in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-1:2007/AC:2014 has the following relationships with other standards: It is inter standard links to SIST EN 60601-1:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-1:2007/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.
You can purchase SIST EN 60601-1:2007/AC:2014 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
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
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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/
...
The article discusses the change in the DOW (Date of Withdrawal) of the standard EN 60601-1:2006, which is titled "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance." The DOW was originally set to be 2018-12-24 but has been revised to 2012-06-01.
記事タイトル：SIST EN 60601-1：2007 / AC：2014-医療用電気機器-パート1：基本安全性と必須性能の一般的な要件 記事内容：原点：BT147 / DG9302 / DVに続き、EN 60601-1：2006のDOW（撤退日）が2018-12-24から2012-06-01に変更されました。
기사 제목: SIST EN 60601-1:2007/AC:2014 - 의료 전기 장비 - 파트 1: 기본 안전 요구 사항과 필수 성능 기사 내용: 출처: BT147/DG9302/DV에 이어, EN 60601-1:2006의 DOW (공식적 비활성일)가 2018-12-24에서 2012-06-01로 변경되었다.
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