X-RAY CONFORMITY TEST

Conformity testing is the most important part of a quality assurance program dealing with aspects of the applicable performance of an x-ray equipment based on radiation control laws. The conformity test is one of the efforts to optimize radiation protection for patients. By conducting a conformity test for an x-ray equipment owned by a health facility, the quality of the x-ray equipment used in the service may be determined.

The purpose of conformity test to an X-ray equipment is to ensure that each irradiation parameter of the equipment is tested for accuracy, linearity, and stability of its functions in accordance with the specifications of the equipment and if a deviation exists, it must be within the agreed tolerance value. The basis of this conformity test refers to The Regulation of Bapeten Head Number 9 of 2011 on Conformity Tests for Diagnostic and Interventional Radiological X-ray Equipment.

TESTED PARAMETERS ON CONFORMITY TEST

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THE ILLUMINATION POWER OF THE COLLIMATOR LAMPS

PERPENDICULARITY COLLIMATION TEST BETWEEN X-RAY BEAM WITH COLLIMATOR LIGHT

VOLTAGE ACCURACY

EXPOSURE TIME ACCURACY

Ma (milliampere) LINEARITY

VOLTAGE REPRODUCIBILITY, EXPOSURE TIME, AND RADIATION OUTPUT

X-RAY BEAM QUALITY (HVL)

X-RAY TUBE LEAKAGE

IMAGE QUALITY AND FOCAL SPOT MEASUREMENT

PATIENT DOSAGE INFORMATION

EXPOSURE OF ROOM RADIATION

LEGAL BASIS FOR THE REGULATION AND LAW ON TESTING AND CALIBRATION

  1. Law Number 36 of 2009 on Health “Article 103 paragraph 1: Safeguarding pharmaceutical preparations and medical devices is performed to protect the public from hazards caused by the use of pharmaceutical preparations and medical devices that do not meet quality and/or safety and/or efficacy/benefits requirements.
  2. Law No. 44 of 2009 on Hospital, Article 7 paragraph 1: Hospitals must meet the requirements of location, building, infrastructure, human resources, pharmaceutical aspects, and equipment. Article 16 paragraph 1: Equipment requirements as referred to in article 7 paragraph (1) cover medical and non-medical equipment which are required to meet service, quality requirements, security, safety, and proper use standards.
  3. Article 16 paragraph 2: Medical equipment as referred to in paragraph (1) must be regularly tested and calibrated by a Health Facility Testing Center and/or an authorized health facility testing institution.
  4. Article 16 paragraph 3: Equipment that uses ionizing rays must meet the conditions and must be supervised by an authorized agency.
  5. Article 16 paragraph 7: Provisions regarding testing and/or calibration of medical devices, standards related to safety, quality, and benefits are implemented in accordance with statutory provisions.
  6. Article 17: Hospitals that do not meet the requirements referred to in articles 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16 are not granted permission to establish, or whose hospital operation license are revoked or are not renewed.
  7. Law No. 10 of 1997 on Nuclear Power, Article 17 paragraph 1: Every use of nuclear power must have a permit, except in certain cases regulated further by a Government Regulation.
  8. Regulation of the Head of Bapeten No 9 of 2011 on “Radiological, Diagnostic, and Interventional X-Ray Equipment Conformity Test.”

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