1. Reason for Revision
The proposed revision prescribes the new protection standards to be observed when using diagnostic radiation generators with a low risk of exposure to the general public other than patients outside medical institutions; and it aims to promote the appropriate operation thereof outside medical institutions by strictly regulating the allowable limit standards for radiation dose leakages outside medical institutions, and it stipulates that the head of a public health center who has received a report on health checkups in accordance with the Regional Public Health Act can also supervise and inspect the status of diagnostic radiation safety management. Further, in order to simplify the related administrative procedures, it stipulates that the same documents shall not be submitted repeatedly when reporting a diagnostic radiation generator, which is a special medical device.
2. Main Contents
a. The revision contains provisions on the standards for radiation protection facilities and the protective measures to be taken when moving diagnostic radiation generators that meet certain conditions, such as weight, maximum tube current, etc., outside medical institutions (Article 9 (3) and Subparagraph 1 (d) 2 of attached Table 2).
b. The revision sets the limit on the allowable leakage of radiation outside medical institutions to 2 milliroentgens (mR) per week (Subparagraph 1 (d) 1 of attached Table 2).
c. The revision includes measures designed to prevent persons other than patients in the definition of safety management from being exposed to radiation (Subparagraph 4 of Article 2).
d. The revision stipulates that the head of a public health center who has received a report on health checkups in accordance with Article 23 of the Regional Public Health Act may supervise and inspect the status of diagnostic radiation safety management (Article 16 (1)).
e. The revision stipulates that, when reporting a diagnostic radiation generator, which is a special medical device, the documents to be submitted ordinarily when registering an item of special medical equipment shall not need to be submitted (Article 3 (1) 1 (g) and Article 3 (1) 1 (h)).
