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Ethicon G11 - Chapter 6 - Conformance to Standards

Ethicon G11
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Generator G11 36
Generator G11 Operator’s Manual
Chapter 6 - Conformance to Standards
The Generator G11 conforms to the following international standards:
EN (IEC) 60601-1 (with Canadian and US
National Deviations)
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
EN (IEC) 60601-1-2
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
EN (IEC) 60601-2-2
Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency
surgical equipment
EN (IEC) 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

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