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CSA Group , 12/01/2015
Publisher: CSA
File Format: PDF
$240.00$480.00
CSA C22.2 No. 60601-2-64:15 (R2020) PDF
Preface:
This is the first edition of CAN/CSA-C22.2 No. 60601-2-64, Medical electrical equipment — Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-64 (first edition, 2014-09). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
For brevity, this Standard will be referred to as "CAN/CSA-C22.2 No. 60601-2-64" throughout.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).
201.1.1 Scope: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of PATIENTS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of LIGHT ION BEAM ME EQUIPMENT
NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION?S premises.
NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
NOTE 3 Information regarding x-ray image guidance can be found in IEC 60601-2-68 (under development).
NOTE 4 IEC 61217 gives guidance on the designation of ME EQUIPMENT movements, the marking of scales, their zero positions and the direction of movement with increasing value (see 201.7.4.101).
201.1.2 Object: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for LIGHT ION BEAM ME EQUIPMENT in the range 10 MeV/n to 500 MeV/n and to SPECIFY tests to check compliance to those requirements.
NOTE The adoption of this standard helps to ensure that the ME EQUIPMENT
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