ASTOFLO PLUS ECO Instructions for Use
14 Conformity with international standards
56
14 Conformity with international standards
Standard
Title
IEC/EN 60601-1
ANSI/AAMI ES 60601-1
CAN/CSA C22.2 No.
60601-1
Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
IEC/EN 60601-1-2
Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility
– Requirements and tests
IEC/EN 60601-1-6
Medical electrical equipment - Part 1-6:
General requirements for basic safety and essential
performance. Collateral Standard. Usability.
IEC/EN 60601-1-8
Medical electrical equipment - Part 1-8:
General requirements for basic safety and essential
performance - Collateral Standard: General
requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical
systems.
ASTM F 2172-02
Standard Specification for Blood/Intravenous
Fluid/Irrigation Fluid Warmers
