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YY 0626-2008 English PDF

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YY 0626-2008: Dental casting alloys with noble metal content of at least 25% but less than 75%
Status: Obsolete

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0626-2008	English	439	Add to Cart	4 days [Need to translate]	Dental casting alloys with noble metal content of at least 25% but less than 75%	Obsolete	YY 0626-2008

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Basic data

Standard ID	YY 0626-2008 (YY0626-2008)
Description (Translated English)	Dental casting alloys with noble metal content of at least 25% but less than 75%
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C33
Classification of International Standard	11.060.10
Word Count Estimation	11,190
Date of Issue	2008-04-25
Date of Implementation	2009-12-01
Quoted Standard	GB/T 15072.1; GB/T 15072.2; GB/T 15072.3; GB/T 15072.4; GB/T 15072.5; GB/T 15072.6; GB/T 15072.7; GB/T 15072.8; GB/T 15072.9; GB/T 15072.10; GB/T 15072.11; GB/T 15072.12; GB/T 15072.13; GB/T 15072.14; GB/T 15072.15; GB/T 15072.16; GB/T 15072.17; GB/T 15072.18; GB/T 15072.19; GB/T 15072.20; GB/T 1423; GB/T 6682; GB/T 4340.1; GB/T 228; YY 0621; ISO 0621
Regulation (derived from)	SFDA [2008] No. 192
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the precious metal content (mass fraction) of 25% to 75 % of the precious metal dental casting alloy (hereinafter referred to as cast alloy) classification, requirements, test methods and packaging, labeling, instruction manual. This standard applies to the manufacture of dental prostheses and devices casting alloys.

YY 0626-2008: Dental casting alloys with noble metal content of at least 25% but less than 75%

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Dental casting alloys with noble metal content of at least 25% but less than 75% ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Precious metal content of 25% to 75% of the dental casting alloy (ISO 8891.1998, MOD) Posted 2008-04-25 2009-12-01 implementation State Food and Drug Administration issued

Foreword

4.1,4.2,4.3,4.4,4.5 and 4.6 of this standard are mandatory, the rest are recommended. This revised standard adopts ISO 8891.1998 "precious metal content of 25% to 75% of the dental casting alloy." Modifications are as follows. --- ISO 8891 standard references ISO 6892, ISO 3696 and ISO 9693 respectively converted to GB/T 228, GB/T 6682 and YY 0621, this standard with the latter replace the former; --- ISO 1562 does not contain a possible biological hazards qualitative and quantitative requirements given only biological evaluation literature Head record. The standard recommended in the evaluation of possible biological hazards, please refer to YY/T 0268. References added YY/T 0268; --- ISO 8891 alloy chemical composition and density of the test method is not specified, this standard specifies the use of GB/T 15072 and GB/T 1423 Methods and to include a reference standard; --- ISO 8891 cites Vickers hardness test method standards, and provides the manufacturer "provides Vickers hardness" 8.1a) in, but There is no provision requiring the Vickers hardness, this increases the Vickers hardness standard requirements (4.5) and test methods (5.3.4). --- The "corrosion 5.7" and "5.8 tarnish resistance" to recommend provisions; --- "Break outer" and "nipper" phenomenon occurs due to the mechanical properties of test samples ISO 1562 design verification test, this standard Quasi modify mechanical properties of test samples ISO 1562 design, the deletion of the "cone shoulder sample", retained the "round clip Head "to" thread chuck "and" circular shoulder sample "(see 5.2.2 Figure 2), and an increase in the sample provided one kind of threaded Meter (see Figure 1 5.2.2); --- Prepared in accordance with the requirements of this standard national standards for ISO 8891 chapters have been adjusted. the "Sample 5", "6 sample preparation" "7 test" to "5 Test methods", "5.1 sample", "sample preparation 5.2," "5.3 Test Method"; the "information and instructions 8 Book "," identifies 9 "to" 6 packaging, labeling and instructions for use ", and in accordance with relevant state regulations supplement the relevant content. The Standard Appendix A, Appendix B is an informative annex. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment. This standard has REVIEW billion of the New Materials Co., drafting. The main drafters of this standard. Feng Jing Su, Yang Yuhui, Liu Fu, Yang Hua.

Introduction

Avoid biological hazards dedicated qualitative and quantitative requirements are not included in this standard, but the evaluation of possible biological hazards, it is recommended to make With ISO 10993-1.2003 and ISO 7405.1997. This standard is not yet specified corrosion and tarnish resistance requirements. But recommended that the static immersion test is given in Appendix A for providing For the kind and amount of metal ions details dental casting alloys precipitated, in Appendix B gives the sodium sulfide tarnish test is used to provide a table Corrosion in the possibility of change in information. When dental alloys corrosion and tarnish test casting international standards (such as ISO 10271) published in Appendix A and Appendix B test given The method will be revised in line with the international standards, the maximum allowed corrosion and tarnish the requirements will be required. By that time it should also be considered a dental cast Making the implementation of the electrochemical characteristics test method. Precious metal content of 25% to 75% of the dental casting alloy

1 Scope

This standard specifies the precious metal content (mass fraction) of 25% to 75% of the precious metal dental casting alloy (hereinafter referred to as cast alloy) sub Class, requirements, test methods and packaging, labeling, instructions for use. This standard applies to the manufacture of dental restorations and the cast alloy components. Note 1. The precious metal content (mass fraction) ≥75% of dental casting gold alloys see YY 0620. Note 2. The manufacture of metal - metal matrix ceramic dental prostheses see YY 0621 with dental precious metal alloys.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 15072.1 ~ 15072.20 precious metals and their alloys - GB/T 1423 precious metals and their alloys density measurement method Laboratory use specifications and test methods GB/T 6682 analysis (GB 6682-1992; modISO 3696. 1987) GB/T 4340.1 Vickers hardness test - Part 1. Test methods GB/T 228 metal materials at room temperature tensile test (GB/T 228-2002, idt ISO 6892.1998) YY 0621 Dental PFM system (YY 0621-2008, ISO 9693.1999, MOD) ISO 3585 laboratory glassware nature Category 3 According to the mechanical properties of casting alloys and their recommended range, which is classified as follows. Type Ⅰ. low strength to withstand the stress of the cast alloy --- small castings, such as inlay; Ⅱ type. --- moderate cast alloy castings to withstand moderate stress, such as inlays, onlays and crowns; Ⅲ type. high-strength cast alloy to withstand high stress --- castings, such as onlays, bridges, crowns and saddle group; Ⅳ type. high strength cast alloy to withstand high stress --- and a thin cross section castings, such as saddle group, the tongue palate bar, card ring, sleeve Crown, crown and denture casting a single bracket.

4 Requirements

4.1 Chemical composition Cast alloy of gold and platinum group metal content (mass fraction) of 25% to 75%. Note. The meaning of this standard platinum group metals are platinum, palladium, iridium, ruthenium and rhodium. Cast alloy content of each component (mass fraction) deviation should be the nominal value [see 6.3c)] is within ± 0.5%. Cast alloy of beryllium and cadmium content (mass fraction) should not exceed 0.02%. If the cast alloy nickel content (mass fraction) is greater than 0.1%, which should not exceed the actual amount of the nominal value [see 6.3j)]. 4.2 biocompatibility See YY/T 0268. 4.3 Mechanical properties According to the classification of the cast alloy, the mechanical properties of various types of alloys shall meet the requirements of Table 1.

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