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Medical electrical equipment. General requirements for safety - Collateral standard. Safety requirements for medical electrical systems

BS EN 60601-1-1 covers the safety requirements for medical electrical systems to provide protection for patients, operators and their surroundings.

BS EN 60601-1-1 is the European standard that applies to the safety of medical electrical systems. It describes the safety requirements necessary to provide protection for the patient, the operator and their surroundings.

This collateral Standard specifies general requirements for safety applicable to:

  • A group of medical electrical equipment (for example, radiological equipment)
  • A specific characteristic of all medical electrical equipment, not fully addressed in the general Standard (for example, electromagnetic compatibility).

BS EN 60601-1-1 covers requirements for protection against electric shock hazards, protection against mechanical hazards, protection against hazards from unwanted or excessive radiation, protection against hazards of ignition of flammable anesthetic mixtures, protection against excessive temperatures and other safety hazards, accuracy of operating data and protection against hazardous output, abnormal operation and fault conditions, and environmental test.

History and related standards

BS EN 60601-1-1 supersedes BS EN 60601-1-1:1993 which is withdrawn.

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