YY 1027: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 1027-2018 | English | RFQ |
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7 days [Need to translate]
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Dentistry--Hydrocolloid impression materials
| Obsolete |
YY 1027-2018
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| YY/T 1027-2018 | English | 969 |
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Dentistry-Hydrocolloid impression materials
| Valid |
YY/T 1027-2018
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| YY 1027-2001 | English | 599 |
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4 days [Need to translate]
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Dental alginate impression material
| Obsolete |
YY 1027-2001
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PDF similar to YY 1027-2018
Basic data | Standard ID | YY 1027-2018 (YY1027-2018) | | Description (Translated English) | Dentistry--Hydrocolloid impression materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 41,485 | | Date of Issue | 2018-06-14 | | Date of Implementation | 2019-07-01 | | Older Standard (superseded by this standard) | YY 1027-2001; YY 0494-2004 | | Regulation (derived from) | Announcement No. 38 of the State Drug Administration | | Issuing agency(ies) | State Drug Administration | YY 1027-2018: Dentistry--Hydrocolloid impression materials---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--Hydrocolloid impression materials
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 1027-2001, YY 0494-2004
Dentistry hydrocolloid impression material
(ISO 21563.2013, MOD)
Published on.2018-06-14
2019-07-01 implementation
State Drug Administration issued
Content
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification of agar water colloid impression materials 3
5 Requirements---Features and Performance 3
6 pre-test treatment 4
7 Test method 7
8 Labels and Instructions for Use 18
Appendix A (Normative Appendix) Schematic diagram of equipment and accessories for testing 21
Appendix B (informative) Preparation of an optional sample holding method for the tear resistance test 34
Reference 38
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 1027-2001 "dental alginate impression material" and YY 0494-2004 "dental agar-based water gel impression"
material".
Compared with YY 1027-2001 and YY 0494-2004, the main technical changes except the editorial modification are as follows.
--- Increased the classification of agar material 3A type, and added the sample preparation step for the 3A type material in the project involved;
--- Added test methods and requirements for tensile bond strength and linear dimensional change of 3A type materials;
--- Removed the requirements and test methods for the appearance of the product, the appearance of the blend, and the test methods in YY 1027-2001 and YY 0494-2004.
This part of the content is checked in Chapter 6, "Pre-Test Processing";
--- Removed the requirements for extrusion temperature, gel temperature and extrudability of agar material, and this part is in Chapter 6 "Before the test
Check at the "phase";
--- Removed the alginate material compressive strength project and increased the tear resistance performance project;
--- Modified the details of the alginate material and the agar material, and the test method was modified accordingly.
This standard uses the redrafting method to modify the use of ISO 21563.2013 "dental science hydrocolloid impression materials."
The technical differences between this standard and ISO 21563.2013 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.
a) Replace ISO 3696 with GB/T 6682 modified to international standards.
b) 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).
c) Replace ISO 6873 with YY 0462 modified to the international standard.
Please note that some elements of this standard may involve patents. The issuing organization of this standard does not assume responsibility 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 is drafted by. State Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center.
Participated in the drafting of this standard. Rijin Dental Materials (Kunshan) Co., Ltd., Shanghai Medical Devices Co., Ltd. Dental Materials Factory.
The main drafters of this standard. Bai Wei, Lin Hong, Yuan Shenpo, Shen Xiwei, Qin Jie, Xu Zhengguo, Du Zumin, Zheng Gang, Sun Zhihui.
The previous versions of this standard were released as follows.
---YY 1027-2001;
---YY 0494-2004.
Dentistry hydrocolloid impression material
1 Scope
This standard specifies the performance requirements and test methods for elastic aqueous agar and alginate hydrocolloid dental impression materials in order to determine their ability
Whether the expected quality of use is achieved. At the same time, the requirements for the instruction manual and label are specified.
This standard applies to elastic aqueous agar and alginate hydrocolloid dental impression materials.
Note. This standard does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended to evaluate the potential biological hazards of hydrocolloid impression materials.
Refer to ISO 10993 and ISO 7405.
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 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD)
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 0462-2018 Dental Gypsum Products (ISO 6873.2013, MOD)
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
Bonding bonding
The viscous properties of the reversible and irreversible stamp components in the impression material, resulting in the formation of individual components that require separate interactions
A uniform impression system to achieve the desired elasticity and effective impression, and can be successfully removed from the mouth.
3.2
Large packaging container bulkcontainer
Labeled sales or direct packaging containers containing bulk granules, liquids, powders or other loose materials, usually in packs
The amount required for more than one oral clinical treatment or laboratory operation.
3.3
Reversible/irreversible impression material bonding system combinedreversible/non-reversibleimpressionmaterialsystem
The low consistency agar material is first injected around the selected tooth and can be passed through the irreversible alginate impression material during impression molding.
An impression system that is used under pressure bonding.
3.4
Sales package consumerpackaging;retailpackaging;salespackaging
A unit of sale that contains the package and its contents at the time of retail sale to the end user or consumer.
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