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BIJLAGE 7
TECHNISCHE STANDAARDEN
• IEC 60601-1:2005/AMD1:2012/ AMD2:2020
Medical electrical equipment, Part 1: general requirements for basic safety
and essential performance.
• IEC 60601-1-2:2014/ AMD1:2020
General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests.
• IEC 60601-1-8:2006/AMD1:2012/ AMD2:2020
General requirements for basic safety and essential performance –
Collateral Standard: General requirements, tests and guidance for alarm sy-
stems in medical electrical equipment and medical electrical systems.
• IEC 60601-1-11: 2015/ AMD1:2020
General requirements for basic safety and essential performance -
Collateral Standard: Requirements for medical electrical equipment and me-
dical electrical systems used in the home healthcare environment.
• IEC 60601-2-24:2012
Particular requirements for the basic safety and essential performance of in-
fusion pumps and controllers.
• IEC 60529:1989/AMD2:2013
Degrees of protection provided by enclosures (IP Code).
83
UNCONTROLLED COPY FOR INTERNAL USE ONLY
IFU PS3TLNL/MND Rev.0 03-2022
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