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Dentistry - Soft lining material for removable dentures - Part 2: Materials for long-term use
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| YY 0714.2-2009 | English | 359 |
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Basic data | Standard ID | YY 0714.2-2016 (YY0714.2-2016) | | Description (Translated English) | Dentistry - Soft lining material for removable dentures - Part 2: Materials for long-term use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 14,185 | | Date of Issue | 3/23/2016 | | Date of Implementation | 2018-01-01 | | Older Standard (superseded by this standard) | YY 0714.2-2009 | | Quoted Standard | ISO 1942; ISO 3696; ISO 6344-1; ISO 7619-1; ISO 8601; ISO 20795-1 | | Adopted Standard | ISO 10139-2-2009, IDT | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration |
YY 0714.2-2016: Dentistry - Soft lining material for removable dentures - Part 2: Materials for long-term use ---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 - Soft lining material for removable dentures - Part 2. Materials for long-term use
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
YY 0714.2-2016/ISO 10139-2..2009
Replacing YY 0714.2-2009
Dental activity denture soft lining material
Part 2. Long - term use of materials
Part 2. Materialsforlong-termuse
(ISO 10139-2..2009, IDT)
2016-03-23 release
2018-01-01 implementation
State Food and Drug Administration issued
Foreword
The technical content of this section is mandatory.
YY 0714 "dental activity denture soft lining material" consists of two parts.
- Part 1. short-term use of materials;
- Part 2. Long - term use of materials.
This part is part 2 of YY 0714.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0714.2-2009 "Dental denture soft lining material Part 2. Long term use of materials", and
YY 0714.2-2009 compared to the main technical changes are as follows.
- the depth of penetration (version 5.1 in.2009) and the corresponding test method (2009 version 6.3);
- the depth ratio (2009 edition 5.2) and the corresponding test method (2009 version 6.3) were deleted;
- modified the classification (see Chapter 4, Chapter 4 of the.2009 edition);
- increased bond strength (see 5.3) and its test methods (see 7.3);
- increased water absorption (see 5.4) and its test methods (see 7.4);
- increased dissolution values (see 5.5) and their test methods (see 7.4).
This part uses the translation method equivalent to ISO 10139-2..2009 "Dental activity denture soft lining material Part 2. Long term use
material".
In this part of the normative reference to the international documents have a consistent correspondence between the following documents.
Test method for press hardness of vulcanized rubber or thermoplastic rubber - Part 1. Shore 's hardness tester GB/T 531.1-2008.
(Shore hardness) (ISO 7619-1..2004, IDT);
Analysis of laboratory water specifications and test methods (ISO 3696. 1987, MOD); GB/T 6682-2008;
--- GB/T 7408-2005 Data element and exchange format Information exchange date and time representation (ISO 8601..2004,
IDT);
GB/T 9258.1-2000 Particle size analysis for abrasive abrasives - Part 1. Particle size composition (idtISO 6344-1.
1998);
GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts), IDT];
- YY 0270.1-2011 Dentistry base polymer - Part 1. Denture base polymer (ISO 20795-1..2008,
IDT).
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part is headed by the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99).
This part of the drafting unit. the State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center, Shanghai Second Medical Zhangjiang Biomaterials
Material Co., Ltd., Japan into dental materials (Kunshan) Co., Ltd.
The main drafters of this part. Lin Hong, Bai Wei, Jiang Lan, Xu Zhenguo, Sun Zhihui, Zheng Rui, Xia Jun, Shen Xiwei.
This section was first released in June.2009.
YY 0714.2-2016/ISO 10139-2..2009
Introduction
In this part of YY 0714, the long-term use of oral soft lining materials is classified according to the degree of softness and softness of the material. Though not
The evidence shows which soft and hard material is better, but the purpose of this classification is to help the clinician gain more information and make the appropriate
s Choice.
This part increases the requirements for the bonding strength, water absorption and solubility of the denture base. Using a new test soft lining material soft
Hardness test, ie Shore A hardness test. This test replaces the needle penetration test in YY 0714.2-2009.
This section does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that in assessing possible biological hazards, see
YY/T 0268 and GB/T 16886.1.
YY 0714.2-2016/ISO 10139-2..2009
Dental activity denture soft lining material
Part 2. Long - term use of materials
1 Scope
This part of YY 0714 specifies the softness, adhesion, water absorption and solubility of long-term denture soft lining materials, as well as packaging,
Logo and manufacturer's instructions. These materials can also be used for maxillofacial repair.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
ISO 1942 (all parts) oral vocabulary (Dentistry-Vocabulary)
ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification
andtestmethods)
ISO 6344-1 Particle size analysis for abrasive abrasives - Part 1. Coated composition - Coatedabrasives - Grainsize
analysis-Part 1. Grainsizedistributiontest)
ISO 7619-1 vulcanized rubber or thermoplastic rubber - Test method for hardness - Part 1. Shore 's hardness tester (Shore hardness)
[Rubber, vulcanizedorthermoplastic-Determination ofindentationhardness-Part 1. Durometer
method (Shorehardness)]
ISO 8601 data element and exchange format information exchange date and time representation (Dataelementsandinterchange
formats-Informationexchange-Representationofdatesandtimes)
ISO 20795-1 Dental science base polymer Part 1. Dentistry-Basepolymers-
Part 1. Denturebasepolymers)
3 terms and definitions
ISO 1942 and the following terms and definitions apply to this document.
3.1
Denture soft lining material softdentureliningmaterial
Soft and elastic material, adhesion to the denture of the tissue surface, in order to reduce the support of tissue damage.
3.2
Long-term use long-termuse
Use for more than 28 days.
3.3
Direct packaging container immediatecontainer
A container in direct contact with the material.
4 classification
For the long-term use of the denture soft lining material, according to 7.2 on the 24h Shore A hardness test (5.1) the following classification.
YY 0714.2-2016/ISO 10139-2..2009
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