What is BS EN IEC 60601‑2‑20 about?
BS EN IEC 60601 discusses medical electrical equipment. BS EN IEC 60601‑2‑20 is about infant transport incubators. BS EN IEC 60601‑2‑20 outlines basic safety and essential performance for infant transport incubators, as defined in 201.3.208, also referred to as medical electrical (me) equipment.
BS EN IEC 60601‑2‑20 specifies 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.
Note: BS EN IEC 60601‑2‑20 does not apply to devices supplying heat via blankets, pads, or mattresses in medical use, infant incubators that are not infant transport incubators, infant radiant warmers, and infant phototherapy.
Who is BS EN IEC 60601‑2‑20 for?
BS EN IEC 60601‑2‑20 on medical electrical equipment is useful for:
- Manufactures of infant transport incubators
- Test centers for infant transport incubators
- Infant healthcare regulatory authorities
- Personnel involved with transporting incubators
- Hospital and non-hospital environments where infant transport incubators are used
Why should you use BS EN IEC 60601‑2‑20?
Air-controlled transport incubators control air temperature automatically by an air temperature sensor close to a value set by the operator. Infant transport incubators create a hazard to a patient’s health if incubators don’t perform well. Minimum safety requirements are considered in BS EN IEC 60601‑2‑20 to provide a practical degree of safety in the operation of infant transport incubator equipment.
BS EN IEC 60601‑2‑20 guidelines help you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, and excessive temperatures and other hazards for infant transport incubators. This minimizes hazards to the patient and operator.
What’s changed since the last update?
BS EN IEC 60601‑2‑20:2020 supersedes IEC 60601‑2‑20:2020, which has been withdrawn. BS EN IEC 60601‑2‑20:2020 has re-dated normative references with respect to IEC 60601‑2‑20:2020