TS EN 60601-3-1 Medical Electrical Equipment - Part 3-4: Basic Performance Rule for Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment Passing Through the Skin

The IEC 60601-3-1 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), is a special standard that determines the basic requirements for the performance of oxygen and carbon dioxide partial pressure monitoring equipment passing through the skin. This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-3-1 Medical electrical equipment - Part 3-4: Basic performance rule for oxygen and carbon dioxide partial pressure monitoring equipment passing through the skin.

This standard applies to transcutaneous monitors intended for use with adults, children and newborn babies, and includes the use of these devices for delivery and fetal monitoring. This standard does not apply to hemoglobin saturation oximeters or devices applied to skin surfaces such as mucous membranes.

The oxygen and carbon dioxide partial pressure monitoring method passing through the skin is a method that does not require surgical intervention for patients who need continuous monitoring of oxygen and carbon dioxide with minimum blood supply and is very simple to apply. In neonates and infants, this monitoring method provides very useful clinical information. However, recently the transcutaneous method has been used for older children and adults. Other methods are also used for continuous monitoring of carbon dioxide in adults, but these methods cause adaptation problems or require surgical intervention.

In this respect, oxygen and carbon dioxide partial pressure monitoring equipment passing through the skin has an important area of ​​use and is carried out according to the IEC 60601-3-1 standard, which sets out the basic performance criteria for these devices. tests are important.

Tests in accordance with IEC 60601-3-1 standard are also carried out by our organization within the scope of medical device tests.