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GB/T 36108-2018 (GBT36108-2018)

GB/T 36108-2018_English: PDF (GBT 36108-2018, GBT36108-2018)
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BASIC DATA
Standard ID GB/T 36108-2018 (GB/T36108-2018)
Description (Translated English) CAD software technical requirements of fixed dental restoration
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 10,145
Date of Issue 2018-03-15
Date of Implementation 2018-10-01
Drafting Organization Peking University School of Stomatology, Nanjing University of Aeronautics and Astronautics, Shandong Xinhua Medical Devices Co., Ltd
Administrative Organization National Oral Materials and Devices Equipment Standardization Technical Committee (SAC/TC 99)
Proposing organization State Food and Drug Administration
Issuing agency(ies) The General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and the National Standardization Administration of China

Standards related to: GB/T 36108-2018

GB/T 36108-2018
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.10
C 33
CAD software technical requirements
of fixed dental restoration
ISSUED ON. MARCH 15, 2018
IMPLEMENTED ON. OCTOBER 1, 2018
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative References ... 4 
3 Terms and definitions ... 4 
4 Operating environment ... 7 
5 Technical Requirements ... 7 
6 Test methods ... 9 
Annex A (Normative) Preparation and test of standard preparation ... 11 
Bibliography ... 13 
CAD software technical requirements
of fixed dental restoration
1 Scope
This Standard specifies the terms and definitions, technical requirements, test
methods and other requirements for CAD software for fixed dental restoration.
This Standard applies to the design, development and application of CAD software for
fixed dental restoration.
2 Normative References
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to this Standard.
GB/T 9937 (all parts), Dental vocabulary
GB/T 25000.51-2016, Systems and software engineering – Systems and software
quality requirements and evaluation (SQuaRE) – Part 51. Requirements for quality
of ready to use software product(RUSP) and instructions for testing
3 Terms and definitions
For the purposes of this document, the following terms and definitions, and those
defined in GB/T 9937, apply.
3.1
fixed dental restoration
An artificially made restoration to replace and/or restore part or all defective, missing
natural teeth, which patients can’t remove or wear by themselves.
3.2
CAD software for fixed dental restoration
A special software system with which an efficient, high-precision fixed dental
restoration digital model design can be fulfilled, in the human-computer interactive
operating mode, based on the digital dental impression established after the
inlay
A restoration which is inlaid in tooth to restore the shape and function of defective tooth.
4 Operating environment
4.1 Provision of hardware
The hardware shall be provided as follows.
a) above P4-2.0 and its PC;
b) memory more than 1 GB;
c) mouse and keyboard;
d) 24-speed CD-ROM or DVD-ROM drive or equivalent input interface;
e) dental model three-dimensional scanner or intraoral three-dimensional scanner.
4.2 Provision of software
The software shall be provided as follows.
a) operating system of Windows XP and above;
b) edition of OpenGL 2.0 and above.
5 Technical Requirements
5.1 Operating interface
5.1.1 Operating interface of the software shall have a Chinese interface at least; an
English interface can also be added if necessary.
5.1.2 The software operating process storage file names shall be file names named
in Chinese or time; English storage file names can also be provided if necessary.
5.1.3 The software shall support the retrieval of Chinese file names; the retrieval of
English file names can also be provided if necessary.
5.1.4 The terminology used in the software shall be consistent with the terminology
of GB/T 9937 and this Standard.
5.2 Performance requirements
5.2.1 In accordance with the method of Annex A, when using the even-thickness
coping/bridge function of the software to design coping/bridge of standard preparation,
6 Test methods
6.1 Operating interface test
Run the software system; check the operating interface.
6.2 Performance requirement test
6.2.1 Prepare standard preparation according to the method of Annex A; use the
software to be tested to design even-thickness coping/bridge thickened by 0.6 mm;
use a third-party measuring software to cut section evenly (perpendicular to the
rotation center direction of base crown model with an interval of 5°); extract the cervical
margin line intersection point together with the software to be tested; measure the
average of differences between the intersection point and the design curve.
6.2.2 Operators use a stopwatch for measurement; start from the end of scanned
single base crown data input and end at the end of design data output; they shall use
the functions of even-thickness coping/bridge and cut-back coping/bridge to conduct
measurements separately; record the results.
6.3 Function requirement test
6.3.1 Run the software for actual operation to check whether it has the functions
including patient information management and tooth position management.
6.3.2 Run the software for actual operation to check whether it has a guided design
process and has a backspace function.
6.3.3 Run the software for actual operation to check whether its input-output files
include the standard STL data file format at least.
6.3.4 Run the software for actual operation to check whether it has the function of
automatic calculation of an optimal path of insertion.
6.3.5 Run the software for actual operation to check whether it has the functions
including undercut amount prompt and filling undercut.
6.3.6 Run the software for actual operation to check whether it has the functions
including automatic or semi-automatic extraction of preparation cervical margin line,
and cervical margin interactive modification.
6.3.7 Run the software for actual operation to check whether it has the function of
regional parametric adjustment of thickness of adhesive and crown.
6.3.8 Run the software for actual operation to check whether it has the function of
restoration thickness prompt and the function of automatically adding to minimum
thickness.
...