SSH EN 60601-2-11:1997

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

Scope

This standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system. Applies to equipment which is intended to deliver a gamma radiation beam(s) at normal treatment distances greater than 5 cm using a sealed radioactive source(s). Establishes requirements to ensure the radiation safety and enhance the electrical and mechanical safety of gamma beam therapy equipment used in human medical practice and specifies tests for demonstrating compliance with those requirements.

Related directives

Directives related to this standards.