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I.S. EN 60601-1-4:1998被替代

Medical Electrical Equipment - General Requirements For Safety - Collateral Standard: Programmable Electrical Medical Systems

出版：National Standards Authority of Ireland

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基本信息

标准编号： I.S. EN 60601-1-4:1998

标准类别：Standard

出版单位：National Standards Authority of Ireland

标准页数：96

标准简介

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. Also covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.

替代本标准的新标准

I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014

I.S. EN 60601-1:2006

等同采用的国际标准

IEC 60601-1-4 Ed. 1.1 - Identical

NF EN 60601-1-4:1999 - Identical

DIN EN 60601-1-4 (2001-04) - Identical

UNE EN 60601-1-4 : 1997 - Identical

EN 60601-1-4 : 96 AMD 1 99 - Identical

IEC 60601-1-4 : 1.1 - Identical

BS EN 60601-1-4 : 1997 - Identical

NF EN 60601-1-4 : 1999 AMD 1 2005 - Identical