EN 60601-2-49
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DIN EN 60601-2-49 |
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Area | Medical technology |
title | Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunctional patient monitoring equipment |
Latest edition | 12.2002 |
ISO | {{{ISO}}} |
The EN 60601-2-49 titled "Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment" is part of the series of standards EN 60601 .
The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-49 .
The standard is based on the international version IEC 60601-2-49. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-49 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for the safety, tests and guidelines of multifunctional patient monitoring devices. 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 12.2002 is accepted as a German standard from the date of its publication .
- The current version (12.2002) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
- In January 2008, a draft for corresponding application was published with the 3rd edition of DIN EN 60601-1.
scope of application
These special stipulations apply to the safety requirements for multifunctional patient monitoring devices. The scope of this standard is limited to devices that have more than one applied part or more than one single function and are intended for connection to a single patient. This standard does not specify any specifications for individual monitoring functions.
extra information
The following changed requirements are contained in EN 60601-2-49 (extract):
- Protection against electric shock
- Protection against radiation ( electromagnetic compatibility )
- Risk of ingress of liquids
- Interruption of the power supply
- Protection against dangerous initial values
- Alarms
- Constructive requirements
- The EN 60601-1-4 (software) must be applied