EN 80601-2-60

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Logo of the German Institute for Standardization DIN EN 80601-2-60
Area Medical technology
title Medical electrical equipment - Part 2-60: Particular requirements for the safety and essential performance characteristics of dental equipment
Brief description: This standard applies to basic safety including the essential performance characteristics of dental treatment units (consisting of dental units and dental instruments).
Latest edition 2009-05 (draft)
ISO IEC 62D / 739 / CD: 2009

The EN 80601-2-60 with the title "Medical electrical equipment - Part 2-60: Special stipulations on the safety including the essential performance characteristics of dental equipment" is part of the EN 60601 series of standards (the EN 60601 series is (as of 2010) transferred to the EN-80601 series).

The DIN standard DIN EN 80601-2-60 is published by the German Institute for Standardization ; ÖNORM ÖVE / ÖNORM EN 80601-2-60 is published by Austrian Standards International .

The standard is based on the international version IEC IEC 62D / 739 / CD: 2009. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-60 , see DIN-VDE standards part 7 . The ICS classification is 11.060.20

This supplementary standard regulates general specifications for the safety, tests and guidelines of dental devices. The purpose is to describe the features of basic safety, the essential performance features and tests and also to provide instructions for their application. These special specifications change or supplement the specifications of the EN 60601-1 standard

validity

  • The final version of the standard is to be used in accordance with the 3rd edition of DIN EN 60601-1.
  • Appeals could be made until July 31, 2009.

scope of application

This International Standard applies to the basic safety and essential performance characteristics of dental units and dental instruments, hereinafter referred to as dental devices. Amalgamators (amalgamators), sterilizers and dental X-ray machines are excluded.

The hazards directly associated with the intended physiological function of the ME device or ME system within the scope of this standard are not taken into account by the specific requirements (stipulations) of this standard.

This standard can also be applied to dental units and dental instruments intended for the treatment or alleviation of disease, injury or disability.

extra information

  • This standard is new and has no previous standard.
  • The standard is still in the drafting stage.

The following changed requirements are contained in EN 80601-2-60 (extract):

  • Protection against electrical hazards (separation, leakage currents)
  • Protection against mechanical hazards (elongation at break)
  • Temperatures
  • Hazards and errors
  • Reference to the application of EN 60601-1-2 , EN 60601-1-6 , EN 60601-1-8 , EN 60601-1-9