1 Scope
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.
This standard is applicable to high intensity focused (extracorporeal) ultrasound therapy system (hereafter referred to as HIFU therapy system) with sound working frequency range of 0.5 MHz~2.0 MHz.
2 Normative References
The following documents contain provisions which, by reference into this document, constitute the provisions of this document. For dated references, subsequent amendments to (excluding correction contents), or revisions of, any of these publications do not apply. However, it is encouraged that the Parties that reach an agreement according to this standard should research whether the latest edition of these documents can be used. For undated references, the latest edition referred to applies.
GB/T 191-2000 Packaging - Pictorial Marking for Handling of Goods
GB/T 3947-1996 Acoustical Terminology
GB 9706.1-1995 Medical Electrical Equipment - Part 1: General Requirements for Safety (idt IEC 60601:1988)
GB 9706.15-1999 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical Systems
GB 10152-1997 B Mode Ultrasonic Diagnostic Equipment
GB/T 14710-1993 The Environmental Requirements and Test Methods for Medical Electrical Equipment
GB/T 16540-1996 Acoustics-Measurement and Characterisation of Ultrasonic Fields in the Frequency Range 0.5 MHz to 15MHz-Hydrophone Method
GB/T 19890-2005 Acoustics-High Intensity Focused Ultrasound(HIFU)-Measurements of Acoustic Power and Field Characteristics
3 Terms and Definitions
For the purposes of this standard, the terms and definitions specified in GB/T 3947-1996, GB/T 16540-1996 and GB/T 19890-2005 as well as those listed below apply.
3.1
high intensity focused ultrasound therapy system
the therapy system (hereinafter referred to as HIFU therapy system), in which the ultrasound sent out by the focusing ultrasound sound source composed of single-element or multi-element transducer array penetrates through patients' body surface at the sound (acoustic) intensity acceptable for human's normal structure after passing through acoustic transmission medium, gathers energy on target tissue to cause its coagulative necrosis (or instant inactivation).
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification
5 Requirements
6 Test Method
7 Inspection Rules
8 Marking, Packaging, Transportation and Storage
Annex A (Normative) Safety
