T/CIRA 5-2019 in English

本标准规定了放射性药物生产场所辐射安全设计的要求。
本标准适用于新、改、扩建用于生产含氟-18、锝-99m、碘-131等医用放射性药物的生产场所的辐射安全设计。

Scope

Except for the general requirements such as purpose scope, referenced standards, terms, etc., this specification includes the following main contents:
1. Basic requirements for site selection and factory premises, clearly defining surrounding areas and enterprises that should not be present to avoid future operational disputes; basic requirements for the feasibility of plant design are also provided.
2. General requirements for such designs, including dose constraints for occupational exposure and public exposure, as well as clarifications on controversies regarding sampling standards for waste liquid emissions in the design process. The Environmental Protection Department (formerly) issued a notice No. 430 in 2015 to clarify this issue; the content of this notice was adopted in this document.
3. Radiation zoning principles and specific functional area divisions are clarified, with GB1887-2002 providing general descriptions for control zones and supervision zones, which should be demarcated based on physical boundaries. Specific division methods vary according to different facility layouts; the appendices of this specification provide detailed suggestions for dividing supervision zones and control zones in various functional rooms while following the principle of minimizing intersections between pedestrian and logistics flows. It is specified that pedestrian and logistics entrances cannot be the same.
4. Clear requirements are made regarding filter types, ventilation zone divisions, and pressure differences within different zones for the ventilation system.
5. Requirements are provided for shielding design bases for equipment and safety interlocks for accelerators; although some organizations have integrated door control, ventilation, and dose monitoring into a complete system, this is considered good practice due to its optimization benefits. Given the general applicability of this specification, it does not mandate such integration unless necessary.
6. Principles for selecting and determining the number of radiation monitoring devices are provided. For such facilities, internal irradiation personal monitoring and air pollution monitoring can be exempted from non-sealed operation with iodine-131, but requirements must still be met for site dose rates (including neutron monitoring when using accelerators), surface contamination, and individual dose monitoring.
7. Requirements are specified for the storage and treatment of radioactive waste and the exhaust system's two-stage filtration process. The airflow should flow from high-pollution areas to low-pollution areas (also known as high-activity zones and low-activity zones). Areas requiring independent exhaust systems must be clearly defined, with chimney heights specified in EJ380 as 3 meters higher than nearby buildings; however, considering the short half-life of nuclear isotopes and their proximity to densely populated areas, it is more reasonable for chimneys to exceed the roofline of the building itself. Specific requirements are also provided for radioactive waste decay ponds (tanks) and temporary storage rooms for radioactive waste.
8. Except for radiation safety, this specification clearly addresses requirements related to industrial cylinders, fire protection, and physical security measures, referring to GA1002.