YY/T 1646-2019: Dentistry - Test method for determining radio-opacity of materials

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Scope

This standard specifies a test method for determining the X-ray opacity of a material by
using a standard aluminum plate as a standard. This method is designed to distinguish
X-ray opacity at a clinically meaningful level without considering factors that affect
accuracy, nor factors that affect X-ray opacity itself (such as background noise, X-ray
energy, grey scale correction, and image enhancement). Although these influencing
factors can change the value of X-ray opacity, they cannot change the corresponding
trend compared with a standard of standard thickness (such as aluminum). This test can
be completed by using conventional or digital sensing technology in dental X-ray
machines.

Basic Data

Standard ID	YY/T 1646-2019 (YY/T1646-2019)
Description (Translated English)	Dentistry - Test method for determining radio-opacity of materials
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C33
Classification of International Standard	11.060.10
Word Count Estimation	6,673
Date of Issue	2019
Date of Implementation	2020-04-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies a test method for determining the X-ray resistance of materials using a standard aluminum plate as a standard. This method is designed to discriminate between clinically meaningful levels of X-ray opacity, regardless of factors affecting accuracy, nor its own factors affecting X-ray opacity (such as background noise, X-ray energy, grayscale calibration and image enhancement). Although these influencing factors can change the value of the X-ray opacity, they cannot change the corresponding trend compared to a standard of standard thickness (eg aluminum). This test can be done by conventional or digital sensing techniques of dental X-ray machines.