CSA C22.2 NO. 60601-2-46:24

CSA C22.2 NO. 60601-2-46:24 PDF

CSA Preface

This is the fourth edition of CSA C22.2 No. 60601-2-46, Medical electrical equipment — Part 2-46: Particular requirements for the basic safety and essential performance of operating tables, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-46 (fourth edition, 2023-05). It supersedes the previous edition, published in 2018 as CSA C22.2 No. 60601-2-46 (adopted IEC 60601-2-46:2016). 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. 60601-2-46” 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, edition 3.2, 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. 201.1 Scope and object IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Clause 1, applies, except as follows:

201.1.1 Scope Replacement: This part of IEC 60601 specifies safety requirements for OPERATING TABLES, whether or not having electrical parts, including TRANSPORTERS, used for the transportation of the OPERATING TABLE top to or from the base or pedestal of an OPERATING TABLE with detachable OPERATING TABLE top. NOTE See also IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 4.2. This particular standard does not apply to – dental PATIENT chairs (see ISO 7494-1), – examination chairs and couches, – PATIENT-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43), – OPERATING TABLE heating blankets (see IEC 60601-2-35), – PATIENT transfer equipment, – delivery tables and delivery beds, – medical beds (see IEC 60601-2-52 and EN 50637), and – field tables.

201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for OPERATING TABLES as defined in 201.3.203.