1 Scope
This standard specifies terms and definitions, product classification, technical requirements, test methods, inspection rules, marking and other requirements of the equipment for extracorporeally induced lithotripsy (hereinafter referred to as equipment according to the definition in 3.1).
This standard is applicable to the equipment with electrohydraulic, electromagnetic and piezoelectric pressure pulse generator as lithotripsy wave source, which are mainly used for crushing the urinary stone.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
GB 9706.1-2007 Medical Electrical Equipment - Part 1: General Requirements for Safety (IEC 60601-1: 1988, IDT)
GB 9706.22-2003 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy (IEC 60601-2-36: 1997, MOD)
GB/T 19042.1-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Test - Imaging Performance of X-ray Equipment for Radiographic and Radioscopic Systems (IEC 61323-3-1: 1999, IDT)
GB 10152-1997 B Mode Ultrasonic Diagnostic Equipment
YY/T 0291-2007 The Environmental Requirements and Test Methods for Medical Electrical Equipment
GB/191-2008 Packaging-Pictorial Marking for Handling of Goods
GB/T 13384-1992 General Specifications for Packaging of Mechanical and Electrical Product
3 Terms and Definitions
For the purpose of this standard, the following terms and definitions apply.
3.1
Equipment for extracorporeally induced lithotripsy
It refers to the equipment that conducts treatment by inducing pressure pulse extracorporeally.
3.2
Electrohydraulic lithotriptor
It refers to the equipment that generates pressure pulse by high voltage discharge in the liquid.
3.3
Electromagnetic lithotriptor
It refers to the equipment which generates pressure pulse by means of electromagnetic field variation in coils to cause metal film vibration.
3.4
Piezoelectric lithotriptor
It refers to the equipment which makes multiple piezoelectric chip to produce a small-energy pressure pulse respectively and then gathers at the focus point to crush stone by means of converse piezoelectric effect.
3.5
Lithotriptor with water cushion
It refers to the lithotriptor equipment which is adopted with water cushion without direct contact between human body and water.
3.6
Medical ultrasonic localization device
It refers to the equipment which is adopted with medical ultrasonic imaging technique for observing and determining the intracorporal stone state and position.
3.7
Medical X-ray localization device
It refers to the equipment which is adopted with medical X-ray perspective imaging technique for observing and determining the intracorporal stone state and position.
3.8
Pressure pulse
It refers to the sound wave emitted from the equipment.
3.9
Focus of pressure pulse
It refers to the point with maximum compressed sound pressure after the pressure pulse is focused
3.10
Focal volume
It refers to the space volume comprised of the surface defined by the -6 dB isobaric line of compressed sound pressure peak.
3.11
1 Scope
2 Normative References
3 Terms and Definitions
4 Product Classification
5 Technical Requirements
6 Test Methods
7 Inspection Rules
8 Marking, Packaging, Transportation and Storage
Appendix A (Informative) Examples for Test Devices of X-ray Image Resolution
