YY/T 0644-2008: Ultrasonics-surgical systems. Measurement and declaration of the basic output characteristics

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Scope

This standard specifies.
--- The main non-thermal output characteristics of the ultrasound surgical system;
Note 1. One specific parameter involved is the output sound power. This standard only considers the low frequency component (below 100 kHz) of the total released energy, which may be related to
The cavitation-related high frequency components produced by the tip are not taken into account.
---Measurement method of output characteristics;
--- The characteristic parameters that the equipment manufacturer should publish.
Note 2. For the sake of simplicity, this standard does not consider all possible complex appearances and shapes of the tip of the treatment head. Explain the parameters and measurements in a straight line
The tip of the tube shape is taken as an example. If required, users of this standard apply more complex designs using the basic methods described in the standard.
The equipment to which this standard applies shall also meet the requirements of a), b) and c) below.
a) operate in the frequency range of 20kHz to 60kHz;
b) for the breaking or cutting of human tissue (regardless of whether these effects are related to the removal or solidification of the tissue);
c) Sound waves transmit energy to the surgical site through specially designed waveguides.
Note 3. Examples of this type of system are surgical aspirator, internal lithotripter, end cutting device, and the like.
This standard does not apply to.
--- A gravel device that introduces a pressure pulse in vitro and focuses through a liquid medium and human soft tissue;
---Surgical device (thermotherapeutic system) as part of the treatment process;
--- The surgical application where the acoustic application site is not at the tip of the longitudinal vibrating treatment tip and therefore does not conform to the unipolar model used in this standard.
Note 4. In this standard, the term “accuracy” refers to the total uncertainty at the 95% confidence level.

Basic Data

Standard ID	YY/T 0644-2008 (YY/T0644-2008)
Description (Translated English)	Ultrasonics-surgical systems. Measurement and declaration of the basic output characteristics
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C41
Classification of International Standard	11.040.01; 17.140.50
Word Count Estimation	24,220
Date of Issue	2008-04-25
Date of Implementation	2009-06-01
Quoted Standard	IEC 60500-1974; IEC 61205-1993
Adopted Standard	IEC 61847-1998, IDT
Regulation (derived from)	SFDA [2008] No. 192
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies: ultrasonic surgical system's main non-thermal output characteristics, output characteristic measurement method, equipment manufacturers should publish the characteristic parameters. Equipment covered by this standard shall also meet the following a), b) and c) requirements: a) operating in the frequency range of 20kHz to 60kHz, b) for human tissue crushing or cutting (regardless of whether the role and organization of these the removal or coagulation related), c) the specially designed acoustic wave energy is delivered to the surgical site. This standard does not apply