2. Getting involved
3. Standards Committees
4. DKE

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

Overview

This part of the 80601 series of International Standards applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201. These particular requirements apply to MULTIFUNCTIONAL PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS. This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG, invasive pressure, or pulse oximetry. The particular requirements related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME equipment. These particular requirements address the additional requirements related to MULTIFUNCTION PATIENT MONITORS. MULTIFUNCTION PATIENT MONITORS can be integrated into other ME equipment or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards also apply. The standard differs from DIN EN IEC 80601-2-49 (VDE 0750-2-49):2020-10 as follows: a) update of the reference to the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; b) normative references have been updated; c) references in the "Terms and definitions" clause have been updated; d) the "NON-SELF-HOLDING and SELF-HOLDING ALARM SIGNALS" clause has been revised; e) the "ALARM SYSTEM protocol" clause has been revised. The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS.

Responsible national committee

DKE/GUK 804.5 - Diagnostik und Brain Computer Interfaces