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YY 0462-2018: Dentistry--Gypsum products
Status: Obsolete YY 0462: Evolution and historical versions
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Dentistry--Gypsum products
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PDF similar to YY 0462-2018
Basic data | Standard ID | YY 0462-2018 (YY0462-2018) | | Description (Translated English) | Dentistry--Gypsum products | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 21,215 | | Date of Issue | 2018-06-14 | | Date of Implementation | 2019-07-01 | | Older Standard (superseded by this standard) | YY 0462-2003 | | Regulation (derived from) | Announcement No. 38 of the State Drug Administration | | Issuing agency(ies) | State Drug Administration | YY 0462-2018: Dentistry--Gypsum products---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dentistry--Gypsum products
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0462-2003
Dental science gypsum products
(ISO 6873.2013, MOD)
Published on.2018-06-14
2019-07-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0462-2003 "Dental Gypsum Products".
The technical changes in this standard compared with YY 0462-2003 are as follows. These changes are due to changes in ISO 6873.2013.
--- Chapter 1, "Scope" added "This standard does not apply to dental bone substitutes consisting of calcium sulfate hemihydrate (or gypsum)";
--- Added Chapter 2 "Regulatory References", and subsequent changes to the chapter numbers;
--- Chapter 3 "Terminology and Definitions" added "GB/T 9937.1-2008, GB/T 9937.2-2008, GB/T 9937.3-2008,
"GB/T 9937.4-2005, GB/T 9937.5-2008 defined";
--- Chapter 4 "Classification" is changed to.
a) Type 1. dental impression plaster;
b) Type 2. dental fixed plaster (Class 1) and model plaster (Class 2);
c) Type 3. dental model artificial stone;
d) Type 4. dental (high-strength, low-expansion) surrogate artificial stone, model base and CAD/CAM (computer-aided design and system)
Build)
e) Type 5. Dental (high-strength, high-expansion) surrogate artificial stone with high expansion to compensate for certain materials used in dental restorations
shrink.
--- The original 4.1 "appearance" was changed to 5.1 "quality";
---5.3 "Curing time" increased the "labeled value on the product packaging";
---5.4 "Line curing expansion" increased the curing expansion of type 2 (type 1) gypsum line 0.00%~0.05%, type 2 (type 2) plaster line curing expansion
Expansion of 0.06%~0.30%, line curing of type 4 gypsum for 24h is 0.00%~0.18%;
--- 6.1 "Sampling", adding "retail products suitable for the packaging of the products provided";
--- 7.1 "Visual inspection", added "check whether the packaging, label and information provided meet the requirements of Chapter 8";
---7.2.1.3 added "measurement of equipment from 35mm to 100mm length";
--- Added 7.3.1.2.2 "small cylindrical mold", and "Note. In order to effectively use resources, small molds can be used instead of traditional large molds.
The user should understand that the smaller the area, the fewer indentation points are allowed (according to 7.3.2), and special attention needs to be paid to the first injection.
Between (related to expected curing time)";
--- Added 7.3.1.3 "release agent";
--- The 7.3.2 "test procedure" was modified to increase the test method and test precautions for small cylindrical molds;
--- The 7.3.3 "Evaluation" was modified to separate the Type 1 product from the Type 2, Type 3, Type 4, and Type 5 products;
---7.4.1 "Equipment", modified the triangular section groove, and added 7.4.1.1.2 "square section groove", added Figure 3, Figure 4,
Figure 5;
---7.4.2 "Step", modified the calculation method of 7.4.2.1 "triangular section groove" test result, added 7.4.2.2 "square section
Slot" test method;
---7.4.3 "Evaluation", the measurement results of type 4 materials for 24h were added;
---7.6.2 "Step", the quality of gypsum is changed from 300g to (200 ± 1)g;
--- Added 7.7.1.8 "talc";
---8.2.1 "Recommended water/powder ratio", "curing time", "curing expansion" added to "outer packaging container" "If using graphic symbols, it should be
YY/T 0466.1-2016";
--- The original 7.2.2 "inner packaging" was changed to 8.2.2 "independent packaging";
--- The original 7.3 "Information provided by the manufacturer" was changed to 8.3 "Instructions for use";
--- Delete the original 7.4 "Chinese logo".
This standard uses the redrafting method to modify the use of ISO 6873.2013 "dental plaster products."
The technical differences between this standard and ISO 6873.2013 and their reasons are as follows.
---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Replace ISO 1302.2002 with GB/T 131-2006 equivalent to the international standard;
● Replaced ISO 3696.1987 with GB/T 6682-2008 modified to adopt international standards;
● Replaced ISO 8601.2000 with GB/T 7408-2005 equivalent to the international standard;
● Replace ISO 1942 (all parts) with GB/T 9937 (all parts), the degree of consistency between the two parts
as follows.
* GB/T 9937.1-2008 Oral vocabulary Part 1. Basic and clinical terms (ISO 1942-1.1989, IDT)
* GB/T 9937.2-2008 Oral vocabulary Part 2. Oral materials (ISO 1942-2.1989, IDT)
* GB/T 9937.3-2008 Oral vocabulary Part 3. Oral devices (ISO 1942-3.1989, IDT)
* GB/T 9937.4-2005 Dental terminology - Part 4. Dental equipment (ISO 1942-4.1989, IDT)
* GB/T 9937.5-2008 Oral vocabulary Part 5. Terminology related to testing (ISO 1942-5.1989,
IDT)
● Replace ISO 15223-1 with YY/T 0466.1, which is equivalent to the international standard.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99).
This standard was drafted. State Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center, Shanghai Medical Devices Co., Ltd.
Division Dental Materials Factory.
The main drafters of this standard. Lin Hong, Wu Yang, Zhang Xia Bing, Sun Zhihui, Lin Yao.
The previous versions of the standards replaced by this standard are.
---YY 0462-2003.
Introduction
Since the publication of the previous edition of ISO 6873, due to some of the properties of the already marketed gypsum products (required for newly introduced dental technology)
Some of the requirements specified in this version of the standard apply, so this revision is carried out. This version has been modified for classification, and related requirements are also made.
Appropriate modifications. In addition, it is considered that the type 4 dental artificial stone used to make the CAD/CAM model should not be produced during the 2h period.
Significant cure expansion, while the previous version only gave the requirement for curing expansion at 2h. This version requires Type 4 materials to be tested at 24h.
Curing expands and gives the requirements.
Dental science gypsum products
1 Scope
This standard specifies the classification and performance requirements of gypsum products for dental use, test methods for related requirements, packaging identification and instructions for use.
Book requirements.
This standard applies to the production of dental impressions, models, casting models, prototypes or model bases and plaster products for fixing models.
This standard does not apply to dental bone substitutes consisting of calcium sulfate hemihydrate (or gypsum).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 131-2006 Product Geometry Technical Specification (GPS) Representation of surface structure in technical product documentation (ISO 1302.
2002, IDT)
GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD)
GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2000, IDT)
GB/T 9937.1-2008 Oral vocabulary Part 1. Basic and clinical terms (ISO 1942-1.1989, IDT)
GB/T 9937.2-2008 Oral vocabulary Part 2. Oral materials (ISO 1942-2.1989, IDT)
GB/T 9937.3-2008 Oral vocabulary Part 3. Oral devices (ISO 1942-3.1989, IDT)
GB/T 9937.4-2005 Dental terminology - Part 4. Dental equipment (ISO 1942-4.1989, IDT)
GB/T 9937.5-2008 Oral vocabulary Part 5. Terminology related to testing (ISO 1942-5.1989, IDT)
YY/T 0466.1-2016 Symbols for medical devices for labeling, marking and providing information on medical devices - Part 1. General
Seeking (ISO 15223-1.2012, IDT)
3 Terms and definitions
GB/T 9937.1-2008, GB/T 9937.2-2008, GB/T 9937.3-2008, GB/T 9937.4-2005, GB/T 9937.5-
The following terms and definitions defined in.2008 apply to this document.
3.1
Gypsum product gypsumproduct
A dental product consisting mainly of calcium sulfate hemihydrate and the necessary modifiers.
Note. If it contains pigments and fragrances, it is considered to be a necessary modifier.
4 classification
This standard divides dental gypsum products into five types.
a) Type 1. dental impression plaster;
b) Type 2. dental fixed plaster (Class 1) and model plaster (Class 2);
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