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IEC 60601-2-11

Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment

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Organization: IEC
Publication Date: 1 August 1997
Status: inactive
Page Count: 120
ICS Code (Therapy equipment): 11.040.60
ICS Code (Radiation protection): 13.280
scope:

Object 

Addition:

aa)

This Particular 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 (PES).

bb)

This Particular Standard 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). For EQUIPMENT operating at shorter distances, special precautions may be necessary.

cc)

This Particular Standard applies to EQUIPMENT intended to be:

- used under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the skills required for a particular medical application and acting in accordance with the INSTRUCTIONS FOR USE,

- maintained at predetermined intervals,

- subject to regular checks by the USER,

- used for particular specified clinical purposes e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY.

dd)

This Particular Standard is applicable to the manufacture and some installation aspects of GAMMA BEAM THERAPY EQUIPMENT by the inclusion of TYPE TESTS and SITE TESTS respectively.

ee)

This Particular Standard specifies the requirements for EQUIPMENT. It does not specify the requirements for the RADIATION SOURCES.

Document History

January 1, 2013
Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter...
August 1, 1997
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment
A description is not available for this item.
IEC 60601-2-11
August 1, 1997
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment
Object  Addition: aa) This Particular Standard specifies requirements for the safety of GAMMA BEAM THERAPY EQUIPMENT intended for RADIOTHERAPY in human medical practice and includes EQUIPMENT in...
January 1, 1987
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Gamma Beam Therapy Equipment; (Amendment 1-1988) (Amendment 2-1993) (CENELEC HD 395.2.11 S2: 1990)
A description is not available for this item.

References

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