SRPS EN 60601-2-45:2007

Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

Scope

Formulates appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment. Establishes particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. The safety requirements for the X-ray generator and its sub-assemblies form an integral part of this standard. Cancels and replaces the first edition published in 1998 and constitutes a technical revision.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.