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CAN/CSA-C22.2 NO. 60601-2-17-04 (R2014)
Medical Electrical Equipment - Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading Equipment (Adopted IEC 60601-2-17:04, second edition, 2004-01)
SKU: 2416932
Published by CSA Group
Publication Year 2004
42 pages
Withdrawn
Product Details
CSA Preface
This is the second edition of CAN/CSA-C22.2 No. 60601-2-17, Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-17 (second edition, 2004-01).
It supersedes the previous edition, published in 1994 under the title Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment (adopted CEI/IEC 601-2- 17:1989).
At the time of publication, IEC 60601-2-17:2004 is available from IEC in English only. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety (adopted CEI/IEC Standard 601-1:1988, with Canadian deviations), CSA Supplement C22.2 No. 601.1S1-94 (adopted CEI/IEC Amendment 1:1991), and Amendment 2:1998 (adopted CEI/IEC Amendment 2:1995).
Scope and object
This clause of the General Standard applies except as follows:
1.1
Scope Addition:
1.1.101
This Particular Standard specifies requirements for the safety of automaticallycontrolled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.
1.1.102
This Standard specifies requirements for automatically-controlled AFTERLOADING EQUIPMENT
1.1.103
This Standard specifies requirements for EQUIPMENT intended to be
This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the EQUIPMENT. Such requirements are specified in other standards (see 6.8.3).
1.1.104
The requirements of this Standard are based on the assumptions that:
This Standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that:
This is the second edition of CAN/CSA-C22.2 No. 60601-2-17, Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-17 (second edition, 2004-01).
It supersedes the previous edition, published in 1994 under the title Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment (adopted CEI/IEC 601-2- 17:1989).
At the time of publication, IEC 60601-2-17:2004 is available from IEC in English only. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety (adopted CEI/IEC Standard 601-1:1988, with Canadian deviations), CSA Supplement C22.2 No. 601.1S1-94 (adopted CEI/IEC Amendment 1:1991), and Amendment 2:1998 (adopted CEI/IEC Amendment 2:1995).
Scope and object
This clause of the General Standard applies except as follows:
1.1
Scope Addition:
1.1.101
This Particular Standard specifies requirements for the safety of automaticallycontrolled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.
1.1.102
This Standard specifies requirements for automatically-controlled AFTERLOADING EQUIPMENT
- which contains and uses only beta, gamma, and NEUTRON-emitting SEALED RADIOACTIVE SOURCES,
- which automatically drives the sealed radioactive source(s) from a storage container to a treatment position inside the source applicator(s) and returns the source(s) to the storage container,
- which is designed for connection to a PATIENT, and
- with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems.
1.1.103
This Standard specifies requirements for EQUIPMENT intended to be
- used under the supervision of QUALIFIED PERSONS;
- maintained at predetermined intervals;
- subject to regular checks by the user.
This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the EQUIPMENT. Such requirements are specified in other standards (see 6.8.3).
1.1.104
The requirements of this Standard are based on the assumptions that:
- a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS, and
- the SOURCE STRENGTH(S) of the RADIOACTIVE SOURCE(S) used by the EQUIPMENT is (are) known.
This Standard includes requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that:
- the selected RADIOACTIVE SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
- IRRADIATION is performed by the selected RADIOACTIVE SOURCE configuration for the selected duration;
- IRRADIATION is performed by the EQUIPMENT without causing unnecessary risk to the OPERATOR or other persons in the immediate surroundings.