This Standard specifies terms and definitions, requirements and test methods of the ultrasonic endoscope related to the ultrasonic performance part. This Standard is applicable to ultrasound endoscope and ultrasound probe that extends into the body through the endoscope tube. NOTE: There are many types of ultrasound transducers for current ultrasound endoscopes and ultrasound probes, such as single element rotation, ring array and convex array. This Standard does not consider the appearance and structure of the probe. The test method of parameters takes the rotation of single element, ring array and convex array imaging as examples. If necessary, more complex designs can also use the basic methods described in this Standard.
Basic Data
Standard ID
YY/T 1676-2020 (YY/T1676-2020)
Description (Translated English)
Ultrasound endoscope
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C41
Classification of International Standard
11.040.55
Word Count Estimation
13,183
Date of Issue
2020
Date of Implementation
2022-10-01
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the terms and definitions, requirements and test methods of ultrasound endoscopes related to ultrasound performance. This standard applies to ultrasonic endoscopes and ultrasonic probes that are inserted into the body through the endoscopic tube.
