CAN/CSA-C22.2 No. 60601-1-3-09 PMT1-2015由SCC 发布于 2009-11-01。
CAN/CSA-C22.2 No. 60601-1-3-09 PMT1-2015在国际标准分类中归属于: 11.040 医疗设备。
CAN/CSA-C22.2 No. 60601-1-3-09 PMT1-2015 的最新版本是哪一版？
最新版本是 CAN/CSA-C22.2 No. 60601-1-3-09 PMT1-2015 。
Preface This is the second edition of CAN/CSA-C22.2 No. 60601-1-3, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-3 (second edition, 2008-01). It supersedes the previous edition published in 1998 as CAN/CSA-C22.2 No. 601.1.3 (adopted CEI/IEC 601-1-3:1994). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. Scope, object and related standards 1.1 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 subassemblies of such equipment, where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures. 1.2 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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