Electrical Medical Equipment Tests
TS EN 60601-1-12
These are the test procedures applied to determine the performance, strength, integrity and reliability of the electronic medical product under high temperature operation, intermittent operation, storage and low temperature operation, intermittent operation and storage conditions. It is observed whether there are any problems in the operation of electronic medical samples under specified air conditioning conditions. 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: General rules for basic safety and required performance - Supplementary standard: medical electrical devices used in the environment related to emergency medical service and Specifications for medical electrical systems. 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, medical electrical equipment and systems are increasingly used to monitor, treat, and diagnose patients. These uncontrolled and complex environments often raise concerns about the safety of medical electrical equipment. This standard was developed with contributions from clinicians, engineers and regulators. The purpose of this coverage standard is to provide general requirements for medical devices and systems that are carried and used in an emergency environment and also used in spatial conditions different from ambient conditions.
Standart
- TS EN 60601-1-12