TS EN 60601-2-50 Electrical Medical Equipment - Part 2-50: Specific Features for Basic Safety and Required Performance of Baby Phototherapy Equipment

Medical Device Tests

TS EN 60601-2-50 Electrical Medical Equipment - Part 2-50: Specific Features for Basic Safety and Required Performance of Baby Phototherapy Equipment

The IEC 60601-2-50 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the basic safety and performance criteria and test methods of infant phototherapy equipment that reduce the safety hazards to patients and operators as much as possible.

TS EN 60601-2-50 Electrical Medical Equipment - Part 2-50: Specific Features for Basic Safety and Required Performance of Baby Phototherapy Equipment

This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-66 Electrical medical equipment - Part 2-66: Basic safety and instruments, hearing and hearing aids and special rules for basic performance.

The scope of this standard includes devices used for medical purposes and providing heat through blankets, pads or beds (IEC 80601-2-35 standard), baby incubators (IEC 60601-2-19 standard), baby transport incubators (IEC 60601-2- 20 standard) and baby radiant heaters (IEC 60601-2-21 standard) are not included.

The reference referred to during the application of the IEC 60601-2-50 standardThe main standard is: IEC 60601-1-2 (general requirements for medical electrical equipment, basic safety and basic performance, assurance standard: electromagnetic compatibility).

Phototherapy is a light application used in the treatment of neonatal jaundice. In general, phototherapy is sufficient in the treatment of jaundice in babies. In insufficient cases, blood exchange is required. In phototherapy application, the baby is put in an incubator and light is given from above. The light emitted from fluorescent bulbs breaks down the bilirubin substance in the baby's skin and allows it to be expelled from the intestines. Phototherapy device is a system using blue LED technology. For an effective phototherapy treatment, light waves should penetrate the body as much as possible. Generally, jaundice is harmless and resolves spontaneously. If it is above a certain level, phototherapy treatment is applied according to the level of jaundice.

Tests in accordance with IEC 60601-2-50 standard are also carried out by our organization within the scope of medical device tests.

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