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Document CSA C22.2 NO 60601-1-3-09-CAN/CSA is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.
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CSA C22.2 NO 60601-1-3-09-CAN/CSA Document Information:
Title
Medical electrical equipment — Part 1-3: General requirements for basic safety and essential performance — Collateral Standard: Radiation protection in diagnostic X-ray equipment
Appareils électromédicaux — Partie 1-3 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Radioprotection dans les appareils à rayonnement X de diagnostic
CSA Standards
Publication Date:
Nov 1, 2009
Scope:
This International Standard applies to the BASIC SAFETY and
ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME
SYSTEMS.
This collateral standard applies to X-RAY EQUIPMENT and to
sub-assemblies of such equipment, where RADIOLOGICAL IMAGES of a
human PATIENT are used for diagnosis, planning or guidance of
medical procedures.
Object
The object of this collateral standard is to specify general
requirements that are in addition to those of the general standard
and to serve as the basis for particular standards.
The object of this collateral standard is to establish general
requirements for protection against X-RADIATION in X-RAY EQUIPMENT,
in order that the IRRADIATION of the human PATIENT, the OPERATOR,
staff and members of the public can be kept as low as reasonably
achievable, without jeopardizing the benefit of the RADIOLOGICAL
procedure. Particular standards may specify their appropriate
values and/or measures for general requirements specified in this
collateral standard. The implementation of the general requirements
or the reference to the particular standard instead, shall be
justified in the RISK MANAGEMENT process.
This collateral standard considers RADIATION PROTECTION aspects
related to X-RADIATION only.
Requirements for the control of the electrical energy used to
generate X-RADIATION, which is also an important aspect of
RADIATION PROTECTION, are included in IEC 60601-1 and in particular
standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT
concerned.
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