T/CIRA 5-2019 Active Group standards

T/CIRA 5-2019 Radiopharmaceutical production site radiation safety design requirements

Publish Date: 2019-12-31 Implement Date: 2020-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CIRA 5-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Radiation protection instruments

ICS Name: Radiation protection

Publish Date: 2019-12-31

Implement Date: 2020-03-01

Scope

Scope: This standard specifies the requirements for radiation safety design of production sites for radioactive drugs. This standard applies to the radiation safety design of new, modified, and expanded production sites for medical radioactive drugs containing fluorine-18, technetium-99m, iodine-131, etc. Main technical content: In addition to the general requirements such as the purpose and scope of the standard, referenced standards, and terminology, this specification includes the following main contents: 1. Basic requirements for site selection and buildings. It clarifies the enterprises and areas that are not suitable or should not exist in the surrounding areas, to avoid unnecessary disputes in future operation; and sets basic requirements for the design feasibility of buildings. 2. Clarifies the general requirements for such designs, such as dose constraints for occupational exposure and public exposure. It clarifies the controversy over the adoption of standards for wastewater discharge in the design. The selection of operating methods has always been controversial. The Ministry of Environmental Protection (at that time) issued Document No. 430 of 2015 to clarify this issue, and this specification adopts the content of that document. 3. Clarifies the principles of radiation zoning and the partitioning of specific functional areas. GB1887-2002 provides principled descriptions of supervision zones and control zones. Supervision zones and control zones should be divided by physical boundaries; the specific partitioning of zones should be set according to the different layouts of specific facilities. The appendix of this specification provides specific and clear recommendations for the partitioning of supervision zones and control zones in different functional rooms; and plans the flow of people and materials in accordance with the principle of avoiding cross-traffic as much as possible. This specification clarifies that the flow of people and materials cannot u