CAN/CSA -C22.2 NO. 60601-1-9:15 (R2019) +A2:21 (CONSOLIDATED) PDF

CSA Preface 

This is consolidated edition 1.2 of CAN/CSA-C22.2 No. 60601-1-9, Medical electrical equipment — Part 1-9: General requirements for basic safety and essential performance — Collateral Standard: Requirements for environmentally conscious design , which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-9 (edition 1:2007 consolidated with Amendment 1:2013 and Amendment 2:2020). 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. 60601-1-9" 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 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 

1.1 * Scope 

This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard. 

1.2 Object 

The object of this collateral standard is to specify general requirements, in addition to those of the general standard, for the reduction of the adverse ENVIRONMENTAL IMPACT of ME EQUIPMENT, and to serve as the basis for particular standards.