CAN/CSA-C22.2 NO. 60601-1-2:16 (R2021):2016 Edition
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Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
Published By | Publication Date | Number of Pages |
CSA | 2016-07-01 | 221 |
Preface
This is the fourth edition of CAN/CSA-C22.2 No. 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-2 (fourth edition, 2014-02). It supersedes the previous edition, published in 2008 as CAN/CSA-C22.2 No. 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests (adopted IEC 60601-1-2:2007). 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. 60601-1-2 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).
Scope
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 the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by ME EQUIPMENT and ME SYSTEMS.
BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES is applicable to all ME EQUIPMENT and ME SYSTEMS.
1.2
Object
The object of this collateral standard is to specify general requirements and tests for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES and for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and ME SYSTEMS. They are in addition to the requirements of the general standard and serve as the basis for particular standards.