The IEC 60601-2-33 standard prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes the criteria for the safety and performance of magnetic resonance (MR) equipment and magnetic resonance systems. This standard is to create a number of requirements in order to protect both the patient and the operators.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-33 Electrical medical equipment - Part 2-33: Certain features for the safety of medical diagnostic magnetic resonance equipment used outside the body.
The following standards referenced during the implementation of the IEC 60601-2-33 standard are indispensable: IEC 60601-1-2 (medical electrical equipment, general requirements for basic safety and basic performance, electromagnetic compatibility), IEC 60601-1 (medical electrical equipment, basic General requirements for safety and basic performance) NEMA MS4 (acoustic noise measurements procedure for diagnostic magnetic resonance imaging devices) and NEMA MS8 (characterization of specific absorption rate (SAR) for magnetic resonance imaging systems).
In-vitro medical diagnostic devices are devices used outside of the body (in a laboratory environment). These devices are produced to obtain information about a physiological or pathological condition or congenital anomalies, to determine suitability and safety for potential recipients, or to monitor treatment.
In short, in-vitro medical diagnostic devices are intended for use on humans. These are devices designed with a set of targets and used individually or with other medical devices. The operation of these devices with the expected accuracy and performance depends on having inspections according to domestic and foreign standards.
Tests in accordance with IEC 60601-2-33 standard are also carried out by our organization within the scope of medical device tests.
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