ASTOTHERM PLUS Instructions for Use
14 Compliance with international standards
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14 Compliance with international standards
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
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility –
Requirements and tests
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.
Standard Specification for Blood/Intravenous
Fluid/Irrigation Fluid Warmers