EN 60601-1:2006/A1:2013/AC:2014

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

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene lastnosti (IEC 60601-1:2005/AMD1:2012)

General Information

• Status: Published
• Publication Date: 21-Jul-2014
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-Jul-2014
• Completion Date: 22-Jul-2014
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1:2007/A1:2014/AC:2015 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Relations

• Corrects: EN 60601-1:2006/A1:2013 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 23-Jan-2023

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 standard je istoveten z:EN 60601-1:2006/A1:2013/AC:2014SIST EN 60601-1:2007/A1:2014/AC:2015en,fr,de01-maj-2015SIST EN 60601-1:2007/A1:2014/AC:2015SLOVENSKI
STANDARD
July 2014 IEC 60601-1:2005/AMD1:2012 (Amendment 1 to the third edition)
Medical electrical equipment – Part 1: General requirements for bas
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