E DIN EN IEC 60601-2-2/A1 VDE 0750-2-2/A1:2023-05

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
Class/Status: Draft, valid
Released: 2023 -05 Published: 2023-04 -07
VDE Art. No.: 1701832
End of objection deadline: 2023-06-07

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

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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Title		Format
	Prinz, Thorsten (Hrsg.) Entwicklung und Herstellung medizinischer Software Normen in der Medizintechnik VDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich