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.
WITHDRAWN
SRPS IEC 60601-1-4:1999
95.99
Withdrawal of Standard
WITHDRAWN
SRPS EN 60601-1-4:2010