CSA C22.2 NO 60601-1-6
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
|Publication Date:||1 January 2015|
|ICS Code (Medical equipment):||11.040|
Amendment 1 removes the reference to the complete life-cycle process (including postproduction monitoring and surveillance). IEC 60601 (the series) is confined to performing a TYPE TEST of ME EQUIPMENT. It does not extend to the entire life cycle including postproduction monitoring and periodic maintenance of the USABILITY ENGINEERING PROCESS.