2. Getting involved
3. Standards Committees
4. DKE

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

Overview

This standard specifies particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH FREQUENCY SURGICAL EQUIPMENT and HIGH FREQUENCY SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223. The minimum safety requirements described in these Particular Requirements are intended to provide a reasonable degree of safety during the operation of HIGH FREQUENCY SURGICAL EQUIPMENT. These Particular Requirements extend and supplement IEC 60601-1:2005 and its Amendment 1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The requirements are followed by specifications for the corresponding tests. HIGH FREQUENCY SURGICAL EQUIPMENT with a RATED OUTPUT POWER of not more than 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) are exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements. The standard differs from DIN EN IEC 60601-2-2 (VDE 0750-2-2):2018-12 as follows: a) improvement and supplementation of the definitions of terms; b) additional separation of the requirements for HF surgical equipment and HF surgical accessories; c) new requirement that the contact quality of neutral electrodes used on adults shall be monitored; d) new requirements for equipment capable of high current operation or make use of such.

Document: references other documents

Document: referenced in other documents

Responsible national committee

DKE/UK 804.6 - Therapie, Chirurgie