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

Overview

These particular requirements apply to the basic safety and the essential performance characteristics for invasive blood pressure monitors and medical electrical measuring devices. They amend and supplement IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, and IEC 60601-1:2005/AMD2:2020. The aim of this fourth edition is to align these particular requirements with edition 3.2 of the general requirements and the newly drafted Collateral Standards and their amendments through technical amendments. This document applies to invasive blood pressure monitoring equipment intended for use in professional healthcare facilities and the emergency medical services environment. Within the IEC 60601 series of standards, the particular requirements may modify, replace, or delete the requirements contained in the general requirements and in the Collateral Standards, as appropriate for the medical electrical equipment under consideration, and add further requirements for the basic safety and the essential performance characteristics. A requirement of a particular requirement takes precedence over the general requirements and Collateral standards. These particular requirements do not apply to catheter tubes, catheter needles, Luer locks, taps and tap banks connected to the DOM. These particular requirements do not apply to non-invasive blood pressure monitoring equipment. The standard differs from DIN EN 60601-2-34 (VDE 0750-2-34):2015-01 as follows: a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as with the new editions and amendments to Collateral Standards; b) expansion of the scope to include the emergency medical services environment; c) modification of the essential performance characteristics in Table 201.101; d) modification of the requirements for protection against the ingress of liquid or solid materials; e) addition of principal operating functions; f) deletion of Annex BB Alarm diagrams. These particular requirements apply to the basic safety and the essential performance characteristics for invasive blood pressure monitors and medical electrical measuring devices.

Document: references other documents

Responsible national committee

DKE/GUK 804.5 - Diagnostik und Brain Computer Interfaces