DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
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
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
Order from DIN Media