CAN/CSA C22.2 NO. 60601-2-1:23 PDF

CSA Preface 

This is the fourth edition of CSA C22.2 No. 60601-2-1, Medical electrical equipment — Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV , which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-1 (fourth edition, 2020-10). It supersedes the previous edition, published in 2011 as CAN/CSA-C22.2 No. 60601-2-1 (adopted IEC 60601-2-1:2009). 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 "CSA C22.2 No. 60601-2-1" 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 Standard 60601-1:2005, including Amendment 1:2012, with Canadian deviations). 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 Application 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 Clause 1 of the general standard1 applies, except as follows: 

201.1.1 Scope Replacement: 

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS. NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some installation aspects of ELECTRON ACCELERATORS and their included equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT delivery – intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), – that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having 

• NOMINAL ENERGY in the range 1 MeV to 50 MeV, 

• maximum ABSORBED DOSE RATES between 0,001 Gy × s–1 and 1 Gy × s–1 at the ERP from the RADIATION SOURCE, and 

• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE; and – intended to be

 • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes, 

• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and 

• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON. 

NOTE 2 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION's premises. 

NOTE 3 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water. 

NOTE 4 The limits on maximum ABSORBED DOSE RATES are included for two reasons. The first is due to requirements related to time in this document. This restriction limits the total dose that could be delivered during a SPECIFIED time (examples: timer, TIME TO INTERRUPT or TERMINATE, LATENCY). The second is to limit the amount of RADIATION damage that can occur during the time required to take action (often as a follow up to an INTERRUPTION or TERMINATION OF IRRADIATION). Wherever requirements were made to limit the amount of dose delivered before action is taken, the RADIATION damage was considered to be independent of the dose rate and only dependent on the dose. This would largely hold true if the dose rate stayed within the range stated above. 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). IEC 60976:2007 specifies methods of testing and disclosure of functional performance of medical ELECTRON ACCELERATORS and is intended to facilitate comparisons of accelerator-based ME EQUIPMENTs of different manufacture. IEC 60976:2007 contains no safety requirements, and is not required to show compliance with this document. Until IEC 60976:2007 and IEC TR 60977:2008 are updated to match this document, it is suggested that MANUFACTURERS replace the word "ISOCENTRE" with "EQUIPMENT REFERENCE POINT" when reading the test methods. IEC TR 62926 provides guidance for integration of ELECTRON ACCELERATORS with other equipment. IEC TR 63183 provides guidance on the construction of error and warning messages. 

201.1.2 Object Replacement: 

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ELECTRON ACCELERATORS in the range 1 MeV to 50 MeV and to specify tests to check compliance to those requirements. 

NOTE The adoption of this document helps to ensure that the ME EQUIPMENT • maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS, • maintains OPERATOR and general public safety during ME EQUIPMENT NORMAL USE and failure of the SUPPLY MAINS, • delivers the pre-selected RADIATION TYPE, NOMINAL ENERGY, and ABSORBED DOSE, and • delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT, without causing unnecessary RISK to the PATIENT, the OPERATOR, other persons or the environment.