EN 60601-1-2

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Logo of the German Institute for Standardization 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).