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IEC 60601-2-21 Infant Radiant Warmers Testing

Medical electrical equipment – Part 2-20: the basic safety and essential performance of infant transport incubators

IEC 60601-2-21 Scope:

IEC 60601 2 21 and EN 60601 2 21 testing applies to the basic safety and essential performance of infant transport incubator equipment, as defined in 201.3.211 of this standard, also referred to as medical electronic equipment.

If a clause or sub-clause is specifically intended to be applicable to medical electronic equipment only, or to medical equipment systems only, the title and content of that clause or sub-clause will say so. If that is not the case, the clause or sub-clause applies both to medical electronic equipment and to medical equipment systems, as relevant.

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of IEC 60601-2-21 are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

EN 60601-2-21 specifies safety requirements for infant transport 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.

IEC 60601-2-21 tests do not apply to:

  • Devices supplying heat via blankets, pads or mattresses in medical use; for information see IEC 80601-2-35 [1]1);
  • Infant incubators which are not infant transport incubator; for information see IEC 60601-2-19 [2];
  • Infant radiant warmers; for information, see IEC 60601-2-21 [3];
  • Infant phototherapy; for information, see IEC 60601-2-50 [4].

Keystone Compliance assists manufacturers with IEC 60601-2-21 and EN 60601-2-21 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-21 test lab needs.