IEC 60601-1-4 Ed. 1.1 b:2000 PDF
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Medical electrical equipment – Part 1-4: General requirements for safety – Collateral Standard: Programmable electrical medical systems CONSOLIDATED EDITION
International Electrotechnical Commission , 04/07/2000
File Format: PDF
IEC 60601-1-4 Ed. 1.1 b:2000 PDF
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. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.
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