CAN/CSA-C22.2 NO. 601.2.1-92 (R2001)

Appareils électromédicaux - Deuxième partie: Règles particulières de sécurité pour accélérateurs médicaux d'électrons dans la gamme 1 MeV à 50 MeV (norme CEI 601-2-1:1981 adoptée)

Publication Year 1992
Published by CSA Group
Reaffirmed in 2001
Withdrawn

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Pages: 67

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Preface/Scope

Scope

1.1.1
This Standard applies to MEDICAL ELECTRON ACCELERATORS when used, for therapy purposes, in human medical practice.

1.1.2
This Standard applies to accelerators which deliver a USEFUL BEAM of either X-RADIATION or ELECTRON RADIATION, with energies in the range 1 MeV to 50 MeV, and at maximum ABSORBED DOSE* rates between 0.001 Gy·s-¹ and 1 Gy·s-¹ at 1 m from the RAD IATION SOURCE and at NORMAL TREATMENT DISTANCES between 0.5 m and 2 m from the RADIATION SOURCE. For equipment in which the selection and DISPLAY requirements are automatically controlled, these conditions shall be complied with or equivalent safety provisions shall be made.
*In this Standard all references to ABSORBED DOSE refer to the ABSORBED DOSE in water.

1.1.3
The requirements in this Standard are based on the assumption that a radiation treatment prescription is available which adequately defines the treatment parameters. Equipment complies with this Standard if all the following requirements are met:

(a) it delivers the preselected RADIATION TYPE;
(b) it delivers the preselected energy of RADIATION;
(c) it delivers the preselected ABSORBED DOSE;
(d) it delivers the RADIATION in accordance with the preselected relationship of the USEFUL BEAM to the PATIENT (STATIONARY or MOVING BEAM THERAPY, beam modifying devices, etc.);
(e) it delivers the RADIATION without causing unnecessary risk to the PATIENT, the operator, other persons or the immediate surrounding s.

1.1.4
This Standard applies to equipment intended for use under the jurisdiction of a QUALIFIED PERSON.

This Particular Standard specifies requirements for MEDICAL ELECTRON ACCELERATORS hereinafter referred to as EQUIPMENT designed to be installed and used in accordance with the Rules of the Canadian Electrical Code, Part I.

The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment - Part 1: General Requirements for Safety, hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the scope of this Particular Standard, the EQUIPMENT must meet the combined requirements, as applicable, of both this Particular Standard and the General Standard.

In this Particular Standard, shall indicates a mandatory requirement; should indicates a recommendation, or that which is advised but not mandatory.

Canadian Deviations and Editorial Changes are included in this Standard.