TS EN 60601-2-21 Electrical Medical Equipment - Part 2-21: Specific Features for Basic Safety and Required Performance of Radiant Baby Warmers

TS EN 60601-2-21 Electrical Medical Equipment - Part 2-21: Specific Features for Basic Safety and Required Performance of Radiant Baby Warmers

The TS EN 60601-2-21 standard published by the International Electrotechnical Commission (IEC) describes the basic safety and performance characteristics and test methods of radiant baby warmer equipment. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 60601-2-21 Electrical medical equipment - Part 2-21: Specific features for the basic safety and required performance of radiant baby warmers.

TS EN 60601-2-21 Electrical Medical Equipment - Part 2-21: Specific Features for Basic Safety and Required Performance of Radiant Baby Warmers

This standard describes the safety requirements for baby radiant heaters. This special standard is a standard that complements the IEC 60601-1 standard. In this standard, the requirements are followed by the specifications of the relevant tests. The IEC 60601 2-21 standard has been revised to be structurally compatible with the IEC 60601-1 standard.

The special standard TS EN 60601-2-21 specifies safety requirements for baby radiant heaters and does not apply to the following equipment:

  • Equipment that provides heat through blankets, pillows and mattresses in medical use (IEC 80601-2-35 standard)
  • Baby incubators (IEC 60601-2-19 standard)
  • Baby transport incubators (IEC 60601-2-20 standard)
  • Baby photography equipment (IEC 60601-2-50 standard)

The purpose of this specific standard is to establish certain basic safety and basic performance requirements for baby radiant heaters that minimize hazards to the patient and the operator, and to provide test methods by which compliance with these requirements can be verified.

The two standards referred to as normative in the application of this standard and indispensable for its implementation are:

  • TS EN 60601-1-2 Electrical medical equipment - Electromagnetic disturbances - Properties and experiments
  • TS EN 60601-1-10 Electrical medical equipment - Features for the development of physiological closed-loop controllers

Our organization also provides basic safety and performance testing services for ISO 60601-2-21 radiant infant warmer equipment to businesses as part of our laboratory services .

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