GB16351-1996

Radiological health protection standard on gamma-beam teletherapy equipment in medicine

医用γ射线远距治疗设备放射卫生防护标准

GB 16351-1996 es una norma nacional china obligatoria vigente: Radiological health protection standard on gamma-beam teletherapy equipment in medicine. Sector: Alimentos. Enfoque: Seguridad de productos. Entrada en vigor: 1 dic 1996.

La aplicabilidad depende del alcance del producto, la vía de certificación, los avisos de la autoridad competente y las reglas de transición. Solicite una traducción o verifique la fuente antes de usar esta ficha en una decisión de cumplimiento.

Resumen de cumplimiento

Este resumen está disponible por ahora solo en inglés.

Alcance y aplicabilidad

This standard specifies the basic radiological health protection requirements for medical gamma-beam teletherapy equipment. It applies to the production and clinical use of gamma teletherapy devices. It is mandatory for manufacturers and medical institutions utilizing gamma-ray teletherapy. The standard also references GB 4792 for basic radiological protection standards.

Requisitos técnicos

The standard outlines the dose equivalent limits for staff and the public, adhering to the principles of justification and optimization of radiological protection. For equipment specifications, it mandates a minimum source strength and sets strict tolerances for useful beam air kerma rate errors, asymmetry, and timer accuracy. It also defines geometric precision limits for the isocenter position, central axis indicators, and penumbra width. Safety and protection requirements detail the maximum allowable leakage radiation levels when the source is in both storage and irradiation positions. It specifies maximum transmission rates for collimators and counterweights, alongside limits for beta contamination on equipment surfaces. Facility requirements mandate that the treatment room must be separated from the control room, have specific minimum dimensions, and feature adequate shielding thickness. The entrance must utilize a maze design with interlocked doors to ensure operational safety.

Métodos de ensayo

The standard details evaluation procedures including useful beam air kerma rate measurements, beam asymmetry testing, and timer error checks. It specifies methods for isocenter verification (both mechanical and beam-based using star-shot film exposures), penumbra width determination, and light field vs. radiation field boundary alignment. Additionally, it outlines procedures for checking leakage radiation from the equipment head, transmission rate tests for collimators and counterweights, and beta contamination monitoring.

Preguntas frecuentes

What products are regulated under GB 16351-1996?

It regulates medical gamma-beam teletherapy equipment, covering both the manufacturing process and clinical use of these devices in medical facilities.

What are the key facility requirements for the treatment room?

The treatment room must be separated from the control room, have a minimum area of 30m² and a ceiling height of at least 3.5m. The entrance must feature a maze design with interlocked doors and adequate shielding.

Does the standard specify limits for radiation leakage?

Yes, it sets strict limits for leakage radiation from the equipment head when the source is in both the storage and irradiation positions, as well as maximum transmission rates for collimators and counterweights.

The summary above provides a high-level overview of GB 16351-1996. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 16351-1996 today to access all detailed parameters, tables, and testing procedures.

Indicaciones de aplicabilidad

Tipo: Salud e higiene
CCS: C57
ICS: 13.280
Organismo competente: National Health Commission
Comité técnico: National Health Commission