EN 60601-2-34
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DIN EN 60601-2-34 |
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Area | Medical technology |
title | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitors. |
Latest edition | 11.2001 |
ISO | IEC 60601-2-34: 2000 |
The EN 60601-2-34 with the title "Medical electrical equipment - Part 2-34: Special requirements for the safety including essential performance characteristics of invasive blood pressure monitoring devices" is part of the EN 60601 series of standards .
The DIN standard DIN EN 60601-2-34 is published by the German Institute for Standardization .
The standard is based on the international version IEC 60601-2-34. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-34 , see DIN-VDE standards part 7 .
This supplementary standard regulates general specifications for the safety, tests and guidelines for invasive blood pressure monitors . The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.
validity
The German edition 11.2001 has been accepted as a German standard from the date of its publication .
- The current version (11.2001) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
- A draft for use with the 3rd edition of DIN EN 60601-1 was published in 1.2008.
scope of application
These special stipulations apply to invasive blood pressure monitors and measuring devices as defined in 2.101, hereinafter referred to as device. These special stipulations do not apply to catheter tubes, catheter needles, Luer locks, stopcocks and stopcock banks.
These special stipulations also do not apply to non-invasive blood pressure monitors.
extra information
The following changed requirements are contained in EN 60601-2-34 (extract):
- separation
- Electromagnetic Compatibility (EMC)
- Liquid hazards
- Accuracy of the output values
- Alarms