LIST OF STANDARDS AND CERTIFICATES
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STANDARDS/CERTIFICATE DESCRIPTION
IEC 60601-1 3.1 edition Medical Electrical Equipment – Part 1 : General
requirements for basic safety and essential
performance.
IEC 60601-1-11:2015 Medical Electrical Equipment – Part 1-11 : General
requirements for basic safety and essential
performance – Collateral Standard: Requirements for
medical electrical equipment and medical electrical
systems used in the home healthcare environment
IEC 60601-1-2:2014 (4th EMC Edition) Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances
IEC 60601-1-8:2006+AMD1:2012 Medical Electrical Equipment Part 1-8 General
requirement for basic safety and electrical performance
- Collateral standard: General requirements, tests
and guidance for alarm systems in medical electrical
equipment and medical electrical systems