Abstract

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

Begin

2022-04-21

Planned document number

DIN EN IEC 60601-2-2/A1

Project number

02230982

Responsible national committee

DKE/UK 812.2 - Therapie, Chirurgie  

draft standard

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 62D/1944/CDV:2022); German and English version EN IEC 60601-2-2:2018/prA1:2022
2023-05
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