EN 60601-2-12

Area	Medical technology
title	Medical electrical equipment - Part 2-12: Particular requirements for the safety of ventilators - ventilators for intensive care
Latest edition	3.2007
ISO	IEC 60601-2-12: 2001

The EN 60601-2-12 titled "Medical electrical equipment - Part 2-12: Particular requirements for the safety of ventilators for intensive care -Beatmungsgeräte" was part of the series of standards EN 60601 .

The DIN standard DIN EN 60601-2-12 is published by the German Institute for Standardization .

The standard was based on the international version IEC 60601-2-12. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-12 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for the safety, tests and guidelines of ventilators for intensive care.

validity

This standard was replaced in 2007 by DIN EN ISO 80601-2-12.

scope of application

These special provisions specify safety requirements for ventilators that are intended for use in intensive care.

The scope of application does not include CPAP devices (continuous positive airway pressure), sleep apnea therapy devices, support ventilators, ventilators for emergencies and transport, jet and high-frequency ventilation and oscillation, including devices that are used within a hospital to increase the ventilation of spontaneously breathing patients can be used.

Requirements for ventilators in anesthesia application are specified in EN 60601-2-13 .

extra information

The following changed requirements are contained in EN 60601-2-12 (excerpt):

Interruption of the power supply
Accuracy of the operating data
Alarms (see also EN 60601-1-8 )
Failures and environmental influences