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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 は現行の中国強制国家規格です：Radiological health protection standard on gamma-beam teletherapy equipment in medicine。 業界：食品。テーマ：製品安全。 施行日：1996年12月1日。
適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。
コンプライアンス概要
この概要は現在英語のみで提供しています。
適用範囲
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.
技術要求
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.
試験方法
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.
よくある質問
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.
適用のヒント
- 種別
- 衛生
- CCS
- C57
- ICS
- 13.280
- 所管部門
- National Health Commission
- 技術委員会
- National Health Commission