EN 60601-2-11:1997

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

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Apr 14, 2018

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.50   Radiographic equipment

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
HD 395.2.11 S2:1990

NOW

WITHDRAWN
EN 60601-2-11:1997
99.60 Withdrawal effective
Apr 14, 2018

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 60601-2-11:1997/A1:2004

REVISED BY

PUBLISHED
EN 60601-2-11:2015