Medical Electrical Equipment Laboratory

Classification of Medical Electrical Equipment Based on Standards

Medical electrical equipment is classified according to standards into two categories:

1. Medical Devices: Equipment used for examination, treatment, or monitoring of a patient's condition, or for alleviation or healing of injuries, diseases, or disabilities. (Hereafter referred to as medical devices)
2. Laboratory Equipment: Equipment used for measurement, control, and laboratory activities in the medical field. (Hereafter referred to as laboratory equipment)
3. IVD Equipment: A specific branch of equipment used for testing samples separated from the body to diagnose disease or assess an individual's health status. (Hereafter referred to as IVD equipment)

Introduction to the Laboratory:

The Medical Electrical Equipment Laboratory at Energy and Power Industries Laboratories Company (EPIL) is approved by the Food and Drug Administration, the General Directorate of Medical Equipment, and the country's customs offices for conducting standard tests. This laboratory is also one of the first neutral partner laboratories of the Standards Institute, holding ISO17025 certification and traceable by ILAC.

Services of the Medical Electrical Equipment Laboratory

The main services provided by the Medical Electrical Equipment Laboratory of APIL are as follows:

Key Services for Manufacturers:

• Conducting type tests on medical equipment products with international traceability by ILAC
• Providing consultation and necessary tests for obtaining standard marks for manufactured products
• Reviewing production processes and identifying and resolving potential defects before standard sampling
• Providing technical consultation for equipping laboratories and necessary training in this area
• Offering quality consultation for implementing systems and obtaining related documentation
• Conducting inspections and audits of production lines

Key Services for Importers:

• Handling procedures related to obtaining import permits for goods
• Reviewing and stating necessary standards for importing goods and conducting related tests
• Providing guidance for the procurement and importation process, offering necessary pre-purchase consultations, and identifying potential issues.