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About This Item

 

Full Description

This is the second edition of CAN/CSA-C22.2 No. 60601-2-21. This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This particular standard does not apply to: devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information see IEC 80601-2-35; INFANT INCUBATORS; for information see IEC 60601-2-19; INFANT TRANSPORT INCUBATORS, for information see IEC 60601-2-20; INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50.
 

Amendments, rulings, supplements, and errata

  1. CAN/CSA C22.2 NO. 60601-2-21A-10 (R2018)


    Amendment 1:2018 to CAN/CSA-C22.2 NO. 60601-2-21-10, Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (Adopted amendment 1:2016 to IEC 60601-2-21:2009)