58
LIST OF STANDARDS AND CERTIFICATES
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STANDARD / CERTIFICATE
DESCRIPTION
IEC 60601-1 3.1 edition
Medical Electrical Equipment – Part 1 : General
requirements for basic safety and essential performance.
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
EN ISO 10993-1:2018
Biological evaluation of medical devices - Part 1
EN 1717:2000
Protection against pollution of portable water in water
installation and general requirements of devices to prevent
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IEC 60601-1-6:2010 +A1:2013
Medical electrical equipment - Part 1-6: - Collateral
standard: Usability