This standard specifies terms and definitions, classification, requirements, test methods, inspection rules as well as marking, packaging, transportation and storage of high intensity focused ultrasound therapy system.
It is applicable to extracorporeal focused high intensity focused ultrasound therapy system (hereinafter referred to as HIFU therapy system) which is used for extracorporeal high intensity focused ultrasound ablation therapy.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB/T 3947-1996 Acoustical terminology
GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety
GB/T 14710 The environmental requirement and test methods for medical electrical equipment
GB/T 19890-2005 Acoustics - High intensity focused ultrasound (HIFU) - Measurements of acoustic power and field characteristics
YY/T 0162.1-2009 Medical ultrasound equipment class series - Part 1: B mode ultrasound diagnostic equipment
YY 0505 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standards: Electromagnetic compatibility - Requirements and tests
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 3947-1996 and GB/T 19890-2005 as well as the followings apply.
