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CSA - 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

inactive
Organization: CSA
Publication Date: 1 January 2010
Status: inactive
Page Count: 96
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

Replacement:

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.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

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.

NOTE See also 4.2 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.

Document History

Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
This Standard covers ME EQUIPMENT that is intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
FOREWORD This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC technical committee 62: Electrical equipment in medical practice Full information on the voting for...
January 1, 2010
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
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. If a clause or subclause is...
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
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. If a clause or subclause is...
CAN/CSA-C22.2 NO. 60601-2-21-10
January 1, 2010
Medical electrical equipment — Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Replacement: 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. If a clause or...
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
A description is not available for this item.
March 1, 1998
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Infant Radiant Warmers
A description is not available for this item.
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Infant Radiant Warmers
A description is not available for this item.
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Infant Radiant Warmers
A description is not available for this item.
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Infant Radiant Warmers
A description is not available for this item.

References

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