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How X-Ray Research Has Led to IEC Safety Standards

Posted by TUV Rheinland on Mar 16, 2018 2:27:38 PM
TUV Rheinland

X-Ray: A Brief History

In 1895, German physicist, W.C. Roentgen discovered the X-ray. He found that the right mixture of gasses and high electric voltage would produce an “invisible light,” or ray, that was capable of passing through human tissue leaving only the bones and metals visible. The news of this scientific discovery spread like wildfire and soon became a medical breakthrough. In fact, by 1896, X-rays were already being utilized clinically in the United States for various medical injuries.

xray w shadow.jpg

X-ray apparatus and induction coils invented by W.C. Roentgen

Innovation Doesn't Come Without Risks

Since then, with continuous innovation, the imaging quality of X-ray has greatly improved and has become a standard in the medical field. However, as x-ray imaging became more widely accepted and used, so too did the concerns of its safety and impact on the human body. Since the discovery of radiation and radioactivity more than 100 years ago, radiation protection standards and the philosophy governing those standards have evolved. The changes have been driven largely by two factors: improved information about the effects of radiation on biological systems; and changing attitudes toward acceptable risk.

dr alice w shadow.jpgDr. Alice M. Stewart

In 1953, epidemiologist Dr. Alice M. Stewart discovered a very high correlation between the use of X-ray on pregnant women, and children who had died prematurely from a form of cancer. By the late 1970s, these findings, and others, began to penetrate the medical community. As a result, major American medical groups began recommending that doctors should not routinely X-ray pregnant women. These findings also sparked the development of radiation safety standards for the overall safe operation of medical X-ray equipment. The most well-known standard is IEC 60601-1-3 – ‘radiation protection in diagnostic X-ray equipment.’ This standard helps to maximise the protection of both patients and the medical personnel who operate the equipment regularly. An operator is exposed to insignificant radiation levels as compared to what a patient receives during a single X-ray session. However, accumulated exposure by medical personnel over time could present a health hazard and therefore protecting against this build-up of radiation is specified in several clauses of the IEC 60601-1-3 standard.

It is highly important for medical manufacturers to know and understand the various clauses that exist under the IEC 60601-1-3 standard and several other applicable standards to ensure safe operation of radiography equipment. It is imperative that this equipment undergo an array of certified radiographic testing methods to ensure not only compliance to these standards, but also the safety of its users. 

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Topics: medical devices