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 ist eine gültige verbindliche chinesische Nationalnorm: Radiological health protection standard on gamma-beam teletherapy equipment in medicine. Branchencluster: Lebensmittel. Schwerpunkt: Produktsicherheit. Inkrafttreten: 1. Dez. 1996.

Die Anwendbarkeit hängt vom Produktumfang, dem Zertifizierungsweg, Bekanntmachungen der Behörden und Übergangsregeln ab. Fordern Sie eine Übersetzung an oder prüfen Sie die Quelle, bevor Sie diesen Eintrag für Compliance-Entscheidungen nutzen.

Compliance-Überblick

Dieser Überblick ist derzeit nur auf Englisch verfügbar.

Geltungsbereich und Anwendbarkeit

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.

Technische Anforderungen

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.

Prüfverfahren

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.

Häufige Fragen

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.

Hinweise zur Anwendbarkeit

Normtyp: Gesundheit und Hygiene
CCS: C57
ICS: 13.280
Zuständige Behörde: National Health Commission
Technisches Komitee: National Health Commission