YY/T 1646-2019 English PDF (YY/T1646-2019)

YY/T 1646-2019: Dentistry - Test method for determining radio-opacity of materials
Delivery: 9 seconds. Download (& Email) true-PDF + Invoice.
Get Quotation: Click YY/T 1646-2019 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 1646-2019
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 1646-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.060.10
C 33
YY/T 1646-2019 / ISO 13116.2014
Dentistry - Test method for determining radio-opacity of
materials
(ISO 13116.2014, IDT)
ISSUED ON. OCTOBER 23, 2019
IMPLEMENTED ON. APRIL 1, 2020
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 4
5 Specimen preparation... 5
6 Apparatus... 5
7 Test conditions and procedures... 7
8 Result processing... 8
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).
Please note that some of the contents of this document may involve patents. The issuing
organization of this document does not assume the responsibility for identifying these
patents.
This standard was proposed by the National Medical Products Administration.
This standard is under the jurisdiction of the National Technical Committee on Dental
Materials and Instruments Equipment of Standardization Administration of China
(SAC/TC99).
Drafting organizations of this standard. Dental Medical Devices Testing Center of
Peking University School of Stomatology, Peking University Hospital of Stomatology,
Hospital of Stomatology of Hebei Medical University, and KaVo Kerr Dental (Suzhou)
Co., Ltd.
Main drafters of this standard. Li Yuan, Lin Hong, Zhang Tiejun, Dong Fusheng, Zeng
Jiajia, Xin Junbin, and Yu Meiqing.
Dentistry - Test method for determining radio-opacity of
materials
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
YY/T 1646-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE'S REPUBLIC OF CHINA
ICS 11.060.10
C 33
YY/T 1646-2019 / ISO 13116.2014
Dentistry - Test method for determining radio-opacity of
materials
(ISO 13116.2014, IDT)
ISSUED ON. OCTOBER 23, 2019
IMPLEMENTED ON. APRIL 1, 2020
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Requirements... 4
5 Specimen preparation... 5
6 Apparatus... 5
7 Test conditions and procedures... 7
8 Result processing... 8
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).
Please note that some of the contents of this document may involve patents. The issuing
organization of this document does not assume the responsibility for identifying these
patents.
This standard was proposed by the National Medical Products Administration.
This standard is under the jurisdiction of the National Technical Committee on Dental
Materials and Instruments Equipment of Standardization Administration of China
(SAC/TC99).
Drafting organizations of this standard. Dental Medical Devices Testing Center of
Peking University School of Stomatology, Peking University Hospital of Stomatology,
Hospital of Stomatology of Hebei Medical University, and KaVo Kerr Dental (Suzhou)
Co., Ltd.
Main drafters of this standard. Li Yuan, Lin Hong, Zhang Tiejun, Dong Fusheng, Zeng
Jiajia, Xin Junbin, and Yu Meiqing.
Dentistry - Test method for determining radio-opacity of
materials
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