Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
(IEC 60601-2-2:2017 + AMD1:2023); German version EN IEC 60601-2-2:2018 + A1:2024 Class/Status:
Standard,
valid
Released: 2025-06
VDE Art. No.: 0701597
This standard specifies particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This amendment is intended to align the standard to IEC 60601-1:2005/AMD2:2020. Additionally, this amendment is intended to address several issues reported from the national committees, including but not limited to: - Requirement for including the length of an accessory in the instructions for use - Clarification of test setup for HF Leakage Currents - Considering modes with high DUTY CYCLES above 45% in the risk management - Including text of the interpretation sheet 62D/1703/INF regarding the High Current Mode to annex AA
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