EN 60601-1-2
DIN EN 60601-1-2 | |
---|---|
Area | Medical technology |
title | Medical electrical equipment - Part 1-2: General requirements for safety including the essential performance characteristics - Collateral standard: Electromagnetic compatibility - Requirements
and exams |
Brief description: | This standard applies to the electromagnetic compatibility of medical electrical devices and medical electrical systems and specifies their requirements and tests for electromagnetic compatibility. |
Latest edition | 05.2016 |
ISO |
The EN 60601-1-2 entitled "Electrical Medical devices - Part 1-2: Requirements and tests: - - Electromagnetic compatibility General requirements for basic safety and essential performance Collateral Standard" is part of the series of standards EN 60601 .
The DIN standard DIN EN 60601-1-2 is published by the German Institute for Standardization ; ÖNORM ÖVE / ÖNORM EN 60601-1-2 is published by Austrian Standards International .
The standard is the identical European version of the international standard IEC 60601-1-2. Within the framework of the VDE standards, the standard is classified as VDE 0750-1-2 , see DIN-VDE standards part 7 .
This standard is a supplementary standard to EN 60601-1 and defines requirements and tests for electromagnetic compatibility in the EN 60601 series of standards.
validity
The German edition 12.2007 is accepted as a German standard with its date of issue .
- The versions 12.2007 or 05.2016 are only to be used together with the 3rd edition of DIN EN 60601-1 .
- The previous standard 10.2006 is only to be used together with the 2nd edition of DIN EN 60601-1.
- Until all sub-standards applicable to the device to be tested have been adapted to the 3rd edition of EN 60601-1, the version from October 2006 must still be used.
- The presumption of conformity for the 3rd edition EN60601-1-2: 2007 ends on December 31, 2018; this will be replaced by the 4th edition EN60601-1-2: 2015
scope of application
The standard applies to all electrical, medical devices or systems.
extra information
The following changes have been made to DIN EN 60601-1-2: 2006-10:
- The main technical changes are contained in Section 4. This section also takes into account the risk management process according to EN 60601-1 (3rd edition) as a general requirement.
- A new Appendix B summarizes all changes to labels and instructions from the third edition of EN 60601-1-2.
- The structure of the standard has been adapted to EN 60601-1 (3rd edition).