EN 60601-1-1

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Logo of the German Institute for Standardization DIN EN 60601-1-1
Area Medical technology
title Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Requirements for the safety of medical electrical systems
Brief description: The document applies to the safety of medical electrical systems. It describes the specifications for the safety of medical electrical systems in order to protect patients, the user and the environment.
Latest edition 8.2002
ISO IEC 60601-1-1: 2000

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

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-1-1 . Editor of the Austrian Standard ÖVE / ÖNORM EN 60601-1-1 is Austrian Standards International .

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

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

validity

The German edition 8.2002 has been valid as a German standard since August 1st, 2002 .

  • The system standard was integrated into the 3rd edition of the basic standard EN 60601-1 . With the beginning of the 3rd edition, this standard is obsolete.
  • The current version (8.2002) is to be used in accordance with the 2nd edition of EN 60601-1.

scope of application

This standard applies to the safety of medical electrical systems. Specifications for the safety that are necessary to protect the patient, the user and the environment are described.

extra information

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

  • separation
  • Leakage currents
  • Multiple sockets