EN 60601-1-4

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Logo of the German Institute for Standardization DIN EN 60601-1-4
Area Medical technology
title Medical electrical equipment - Part 1-4: General requirements for safety Collateral Standard: Programmable electrical medical systems
Latest edition 4.2001
ISO IEC 60601-1-4: 1996 + A1: 1999

The EN 60601-1-4 entitled "Electrical Medical devices - Part 1-4: Programmable Electrical Medical Systems: General Requirements for Safety Collateral Standard" is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-1-4 .

The standard is based on the international version IEC 60601-1-4. Within the framework of the VDE standards, the standard is classified as VDE 0750-1-4 , see DIN-VDE standards part 7 .

This supplementary standard regulates general requirements for safety, tests and guidelines for programmable electrical medical systems.

validity

The German edition 4.2001 is accepted as a German standard from the date of its publication .

  • The current version (4.2001) is to be used in accordance with the 2nd edition of DIN EN 60601-1.
  • Attention: The software standard was integrated into the 3rd edition of the basic standard EN 60601-1 . If the 3rd edition is used, this standard is obsolete.

scope of application

This supplementary standard applies to the safety of medical electrical devices and medical electrical systems that contain programmable electrical subsystems (PESS).

Some systems that contain software and are used for medical purposes are outside the scope of this supplementary standard, e.g. B. many medical information systems. The differentiation criterion is whether the system corresponds to the definition of the medical electrical device in 2.2.15 of EN 60601-1 or the definition of medical electrical systems in 2.203 of EN 60601-1-1 .

extra information

The following changed requirements are contained in EN 60601-1-4 (extract):