The IEC 60601-1-12 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes the basic safety and performance criteria of medical devices and systems designed for use in emergency medical services.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1-12 Electrical medical equipment - Part 1-12: Basic safety and general rules for required performance - Auxiliary standard: emergencySpecifications for medical electrical equipment and medical electrical systems used in the environment related to the p service.
The IEC 60601-1-12 standard is an assurance standard and complements the IEC 60601-1 standard for medical electrical equipment.
In the emergency medical services environment, it is increasingly using medical electrical equipment and systems to monitor patients, treat and diagnose disease. These uncontrolled and complex environments often raise concerns about the safety of medical electrical equipment.
This standard has been developed with contributions from clinicians, engineers and regulators. The purpose of this assurance standard is to provide general requirements for medical devices and systems that are transported and used in an emergency environment and also used in space conditions different from the ambient conditions.
A few standards that are indispensable and referred to during the implementation of the IEC 60601-1-12 standard are: IEC 60068-2-27 (environmental testing), IEC 60068-2-31 (environmental testing), IEC 60068-2-64 (environmental tests ), IEC 60529 (degree of protection provided by enclosures, IP code) and IEC 60601-1 (general requirements for medical electrical equipment, basic safety and basic performance).
Tests in accordance with IEC 60601-1-12 standard are also carried out by our organization within the scope of medical device tests.
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