CSA C22.2 NO. 60601-1-3:09 + A1:15 (R2019) + A2:22 (CONS) PDF

CSA C22.2 NO. 60601-1-3:09 + A1:15 (R2019) + A2:22 (CONS) PDF

CSA Preface

This is consolidated edition 2.2 of 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, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-3 (edition 2:2008 consolidated with Amendment 1:2013 and Amendment 2:2021). It supersedes the first edition published in 1998 as CAN/CSA-C22.2 No. 601.1.3 (adopted IEC 601-1-3:1994). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as “CSA C22.2 No. 60601-1-3” 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, including Amendment 1:2012, with Canadian deviations). Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence. This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Applications of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope and object

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.