YY/T 1646-2019Dentistry—Test method for determining radio-opacity of materials (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard is identical to ISO 13116:2014 Dentistry - Test Method for Determining Radio-Opacity of Materials.

The Chinese documents that have consistent correspondence with the international documents normatively referenced in this standard are as follows.

-- GB/T 9937 Dentistry - Vocabulary (ISO 1942, IDT).

1 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.

2 Normative references

The following documents are essential for the application of this document. For any dated referenced document, only the dated version applies to this document. For any undated referenced document, the latest version (including all amendments) applies to this document.

ISO 1942 Dentistry vocabulary

ISO 3665 Photography Intra-oral dental radiographic film and film packets Manufacturer specifications

3 Terms and definitions

For this document, the terms and definitions defined in ISO 1942 apply.

4 Requirements

This standard does not give pass/fail limits for X-ray opacity. If the manufacturer claims that the material is X-ray opaque, the X-ray opacity may be tested in accordance with Chapter 7 and the value obtained shall be at least equivalent to the minimum value specified in the applicable product standard.

NOTE. Aluminum has a radiopacity equivalent to that of dentin; therefore, if a 1 mm thick material has