SR EN 60601-1-4:2002

Medical electrical equipment. Part 1: General requirements for safety. 4 Collateral Standard: Programmable electrical medical systems

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.

General information

Status : Withdrawn
Approval date : 3/28/2002
Publish date : 3/29/2002
Withdrawal date : 6/29/2012
Number of pages : 32
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 22 - Electrical equipment in medical practice

Relations with other standards:

Normative reference SR EN ISO 9001:1995
Normative reference SR EN 60601-1+A1+A2+A13:2001
Normative reference SR ISO 9000-3:1995
Replaced by SR EN 60601-1:2007
Amended by SR EN 60601-1-4:2002/A1:2002