SRPS EN 60601-2-34:2016

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

Scope

IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.