E DIN EN IEC 80601-2-86 VDE 0750-2-86:2019-06

Medical electrical equipment

Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires

(IEC 62D/1628/CD:2018); Text in German and English
Class/Status: Draft, valid
Released: 2019 -06 Published: 2019-05 -17
VDE Art. No.: 1701479
End of objection deadline: 2019-07-17

This particular standard applies to basic safety and essential performance of ECG-equipment and accessories (including ecg electrodes, trunk cables, and lead wires). Additional specific requirements apply to the ECG-equipment based on the intended use claimed by the manufacturer for equipment intended for ECG-patient monitoring, diagnostic, or ambulatory use. This particular standard applies to ECG-equipment for use in professional healthcare facilities as well as in emergency medical service environments and home healthcare environments.

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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