TS EN 60601-2-23 Electrical Medical Equipment - Part 2-23: Distinctive Features for Basic Safety and Required Performance of Partial Pressure Monitoring Devices Passing Through the Skin

The IEC 60601-2-23 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes the basic safety and performance criteria for transcutaneous partial pressure monitoring equipment.

This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-23 Electrical medical equipment - Part 2-23: Specific features for the basic safety and required performance of partial pressure monitoring devices passing through the skin.

This standard applies to transcutaneous monitors for neonates, children and adults. These devices are also used to monitor the fetal condition during birth.

Hemoglobin saturation oximeters and devices applied to surfaces of the body other than the skin, such as the conjunctiva or mucosa, are outside the scope of the IEC 60601-2-23 standard.

A few standards that are indispensable and referred to during the implementation of the IEC 60601-2-23 standard are: IEC 60601-1-2 (general requirements for basic safety and basic performance, assurance standard: electromagnetic compatibility), IEC 60601-1-8 (basic general requirements for safety and basic performance, standard of assurance: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) and IEC 60601-2-49 (specific rules for basic safety and basic performance of multifunctional patient monitoring equipment) .

TranskuTan monitoring is a method used in patients who require minimal blood sampling and continuous monitoring of oxygen and carbon dioxide. In this method, the sensor of the device is placed on the skin surface and blood gases emitted towards the skin are measured. The device provides real-time information and helps to take immediate action to ensure patient safety.

Tests in accordance with IEC 60601-2-23 standard are also carried out by our organization within the scope of medical device tests.