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CSA C22.2 NO 60601-2-19

Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

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Organization: CSA
Publication Date: 1 January 2009
Status: active
Page Count: 103
ICS Code (Medical equipment in general): 11.040.01
scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209 of this standard, 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 safety requirements for INFANT INCUBATORS 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 [3]2);

- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2];

- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [1];

- INFANT PHOTOTHERAPY EQUIPMENT, for information see IEC 60601-2-50 [4].

2) Figures in square brackets refer to the Bibliography.

Document History

Amendment 1:2018 (MOD) to CAN/CSA-C22.2 No. 60601-2-19:09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
This Standard covers ME EQUIPMENT that is intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
Amendment 1:2018 (MOD) to CAN/CSA-C22.2 No. 60601-2-19:09 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
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...
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
A description is not available for this item.
Medical electrical equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209 of this standard, also referred to as ME EQUIPMENT. If a...
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209 of this standard, also referred to as ME EQUIPMENT. If a...
CSA C22.2 NO 60601-2-19
January 1, 2009
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209 of this standard, also referred to as ME EQUIPMENT. If a clause or...
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Baby Incubators
A description is not available for this item.
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Baby Incubators
A description is not available for this item.

References

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