T/CIRA 11-2020 in English
VALIDCobalt-60 sealed radioactive sources for stereotactic radiotherapy system
- Issued on:2020-12-28
- Implemented on:-
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
本文件规定了立体定向放射治疗系统用钴60γ放射源的代号、规格及结构、技术要求、检验方法、检验规则、标志、资料、贮存、包装及运输。
本文件适用于立体定向放射治疗系统用钴60γ放射源。
Introduction
Analysis of the core content of the standard
This standard systematically specifies the technical requirements for the cobalt-60Y radiation source (referred to as the gamma knife source) dedicated to the stereotactic radiotherapy system, mainly including the following technical dimensions:
| Technical elements | Core indicators | Detection methods |
|---|---|---|
| Source core material | Cobalt 59 purity ≥99.5%, nickel layer thickness 5-40μm | Chemical analysis/spectral analysis |
| Clad structure | 022Cr17Ni12Mo2 stainless steel, coaxiality ≤0.05mm | Coaxiality measuring instrument |
| Safety performance | In compliance with GB 4075-2009 C63535/E63535 level | Prototype source test |
| Radiation output | End face output rate deviation ≤±10% | EJ/T788 ionization chamber method |
Detailed explanation of key technical requirements
1. Materials and structure
The source core adopts a nickel-plated cobalt column design and the cladding uses austenitic stainless steel (022Cr17Ni12Mo2 is recommended). The welding penetration depth must be greater than the wall thickness to ensure the sealing reliability within the 15-year safety shelf life.
2. Radiation performance indicators
- End output rate: The air kerma rate at 1m away from the source end face must meet the dose rate requirements of the supporting equipment
- Loading activity: Expanded uncertainty ≤10% (k=2), typical value is 6.7-18TBq (see Appendix A)
- Output consistency: The output rate fluctuation of the whole source group is controlled within ±10%
Key points for standard implementation
Suggestions for inspection process optimization
For the inspection of cladding welding quality, the "3 false and 1 true" inspection strategy can be adopted:
1. First use 3 false sealed sources for leakage test and penetration test
2. The finished source is only subjected to non-destructive leakage test (GB 15849)
Suitability for clinical applications
Appendix A of the standard lists 9 typical specifications, such as:
- RSCODY-AT1 (for head treatment): Φ27.8×50mm, 30 pieces/set
- RSCODY-ZS1 (for body treatment): Φ3.7×20mm, 35 pieces/set
Technology evolution analysis
Compared with the earlier standards, this version has the following major improvements:
1. Material specification: Clarify the stainless steel grade and nickel layer parameters
2. Detection method: Introduce the EJ/T788 high activity source equivalent measurement method
3. Safety period: Extend the shelf life from 10 years to 15 years
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