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GB 17168-2013 English PDF

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GB 17168-2013: Dentistry -- Metallic materials for fixed and removable restorations and appliances
Status: Valid

GB 17168: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 17168-2013	English	454	Add to Cart	3 days [Need to translate]	Dentistry -- Metallic materials for fixed and removable restorations and appliances	Valid	GB 17168-2013
GB/T 17168-2008	English	639	Add to Cart	5 days [Need to translate]	Dental casting precious metal alloys	Obsolete	GB/T 17168-2008
GB/T 17168-1997	English	319	Add to Cart	3 days [Need to translate]	Dental casting precious metal alloys	Obsolete	GB/T 17168-1997

PDF similar to GB 17168-2013

Standard similar to GB 17168-2013

YY/T 1702 YY/T 1692 YY/T 1691 GB 30367 GB/T 44466 GB/T 36917.2

Basic data

Standard ID	GB 17168-2013 (GB17168-2013)
Description (Translated English)	Dentistry -- Metallic materials for fixed and removable restorations and appliances
Sector / Industry	National Standard
Classification of Chinese Standard	C33
Classification of International Standard	11.060.10
Word Count Estimation	23,257
Older Standard (superseded by this standard)	GB/T 17168-2008
Quoted Standard	GB/T 12160-2002; GB/T 16825.1-2008; YY 0466-2003; YY/T 0528-2009; ISO 3696-1987; ISO 6892; ISO 9693; ISO 1942
Adopted Standard	ISO 22674-2006, IDT
Regulation (derived from)	National Standards Bulletin 2013 No. 27
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard applies to the production of dental prostheses and prosthetic devices metallic materials, including porcelain, or not used for porcelain, metal, or both can be classified materials and provides performance requirements. In addition, the stan

GB 17168-2013: Dentistry -- Metallic materials for fixed and removable restorations and appliances

---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.Metallic materials for fixed and removable restorations and appliances ICS 11.060.10 C33 National Standards of People's Republic of China Replacing GB/T 17168-2008 Dentistry fixed and repairing metal material (ISO 22674.2006, IDT) Issued on.2013-12-31 2015-06-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Preface Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Category 2 5 requires 3 6 Sampling 7 7 7 Sample Preparation 8 9 Test Method 9 information and instructions 13 10 logo and tag 14 Appendix A (informative) expected thickness of 0.1mm ~ 0.5mm non-metal material casting 0 tensile test 15 References 18

Foreword

All the technical contents of this standard is mandatory. This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces GB/T 17168-2008 "precious metal dental casting alloy", YY0626-2008 "precious metal content of 25% to 75% Dental casting alloys "and YY0620-2008" Dentistry Gold Alloy. " This standard uses the translation method identical with ISO 22674-2006 "Dentistry fixed and repairing metal material." Correspondence between the consistency of the standards of international documents and normative references of the following documents. RT Test Method. --- GB/T 228.1-2010 metallic materials - Part 1 Tensile test (ISO 6892-1.2009, MOD) --- GB/T 6682-2008 analytical laboratory use specifications and test methods (ISO 3696. 1987, MOD) --- GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)] --- YY0621-2008 Dental PFM system (ISO 9693.1999, MOD) Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee materials and oral appliances and equipment (SAC/TC99) centralized. This standard was drafted. Peking University School of Stomatology Medical Device Quality Supervision and Inspection Center, there is limited research billion of new materials shares The company, your research Platinum Limited. The main drafters of this standard. Zheng Gang, Yuan Shen Po, Lin Hong, Bai Wei, Sun Zhihui, Miao Weidong, Zhang Heng Jin, Zhu Wuxun.

Introduction

This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards, the see ISO 10993-1 and ISO 7405. This standard performance requirements for metal and alloys PFM system in the metal portion of the substitution of the original contained in The ISO 9693 requirements. Combined with the performance requirements of ceramic and metal PFM system between still see ISO 9693. The standard of proof stress and the minimum of the Elongation 0 metal material not specified, but it is recommended in the detection of these properties Using the test procedure specified in Appendix A. When the ISO /TC106SC2 relevant information, these requirements will be listed in the present standard of repair The revised edition. Dentistry fixed and repairing metal material

1 Scope

This standard is used for the production of dental prostheses and prosthetic devices metal materials, including used for porcelain or ceramic, or the two can Metallic materials are classified and specifies performance requirements. In addition, the standard specifies the requirements for packaging and labeling of products, as well as providing material Specification requirements. This standard does not apply to dental amalgam (ISO 24234), dental welding materials (ISO 9333), or orthodontic metallic material (ISO 15841) (such as orthodontic wire, brackets, runners and screws, etc.).

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 12160-2002 uniaxial extensometer calibration test (ISO 9513.1999, IDT) Testing - Part 1 GB/T 16825.1-2008 static uniaxial testing machine. Rally and (or) pressure testing machine force measuring system Verification and calibration (ISO 7500-1.2004, IDT) YY0466-2003 medical equipment used with medical device labels, signs and symbols provide information (ISO 15223.2000, IDT) YY/T 0528-2009 Dental metallic materials corrosion test methods (ISO 10271.2001, IDT) ISO 1942 (all parts) oral vocabulary (Dentistry-Vocabulary) ISO 3696. 1987 for analytical laboratory use specifications and test methods (Waterforanalyticallaboratoryuse-Specifica- tionandtestmethods) ISO 6892 metallic materials at room temperature tensile test method (Metalicmaterials-Tensiletestingatambienttemper- ature) ISO 9693 Dental PFM system (Metal-ceramicdentalrestorativesystems)

3 Terms and Definitions

As defined in ISO 1942 and the following terms and definitions apply to this document. 3.1 Base metal basemetal All metal elements except precious metals and silver. 3.2 Harmful elements hazardouselement Known side effects may have biological elements. NOTE. dental alloys containing such elements (such as an alloying additives or impurities) does not mean that the alloy itself is harmful. 3.3 Metallic material metalicmaterial A material alloys, precious metal or precious metal properties. Note. The metal material may be a pure metal or alloy. 3.4 Cast alloy castingaloy Used for casting metal material in the dental mold. 3.5 Ceramic finishes ceramicveneer Repair thin metal ceramic surface on the body for improving appearance. 3.6 Metal - ceramic metal-ceramic By sintering a ceramic base material facing the metal dental prosthesis together. Note 1. This term also applies to the description of such a metal material used for restoration. In this document, the metal - ceramic alloys are synonyms. Note 2. If the manufacturer has recommended that such materials may not be used for metal porcelain. 3.7 Metal Matrix metalicbase Alloy highest concentration of precious metals or non-precious metals. NOTE. If applicable, the name of the element should be placed in front of the following word "group" word, such as "dental prosthesis with ××× metal material" or "dental ××× Base cast alloy "or" dental ××× metal - ceramic materials. " 3.8 Non-precious metal alloy base-metalaloy Non-precious metal alloy as a main component. 3.9 Cast as-castcondition Taken out from the casting metal material in the metallurgical state of its solid phase. Note. This state depends on the manufacturer's recommended cooling procedure (such as air cooled). 3.10 Air cooling bench-cooling Casting remains in the investment material, the top metal is exposed at room temperature for decentralized on a flat surface of the insulating platform, free flow of air around it straight To the casting down to room temperature. 3.11 Hardening hardening A state metal material after heat treatment, which is 0.2% of non-proportional extension strength than cast. Note. If the manufacturer recommends its use in this state and should be explicitly stated in the instructions for use. 3.12 Softening softening A state metal material after heat treatment, which is 0.2% lower than non-proportional extension strength cast. Note. If the manufacturer recommends its use in this state and should be explicitly stated in the instructions for use. 3.13 Sided inlay one-surfaceinlay The inlay has one and only one surface is exposed to the oral environment for restoring the tooth shape. 3.14 Facing veneer Rough surface of a substrate for a thin layer of material. Category 4 In this document, based on the mechanical properties of metallic materials are divided into six types. The six types of intended use of metallic materials for example as follows. --- Type 0. single tooth to withstand the stress of low fixed prostheses, such as small-sided veneer inlays, decorative crown. Note. Power-casting method or a sintering method to prepare a metal crown with a metal material belonging to Type 0. --- Type 1. Single tooth to withstand low stress fixed partial dentures, veneers, or if no stick-sided inlay surface, facing the crown. --- Type 2. fixed for single tooth restorations, such as crowns or inlays (does not limit the number of surface). --- Three types. fixed for multi-unit restorations, such as bridges. --- 4 type. restorations to withstand extremely high stress with a thin components, such as removable partial dentures, snap rings, thin veneer crown, span Or small cross-section of the bridge, rod attachment and the upper structure of the implant. --- Five types. for applications that require high stiffness and high strength restorations, such as thin removable partial dentures, small cross-section of the site, the snap ring.

5 Requirements

5.1 Chemical composition 5.1.1 Marked components The manufacturer shall declare all ingredients content greater than 1.0% (mass fraction) [see 9.1a)], accurate to 0.1% (mass fraction). The content is not more than 1.0% (mass fraction) but greater than 0.1% (mass fraction) of the component shall be marked with the name or symbol [see 9.1a)]. 5.1.2 Statement content of each component tolerances For silver-based or a noble metal alloy, alloy percentage of each ingredient and packaging, label or interstitial marked deviation value is not greater than 0.5% (mass fraction) [see 9.1a)]. Content of each component for non-precious alloys, the content of more than 20% (by mass) of the packaging, labeling or insert within the indicated value Deviation is less than 2.0% (mass fraction). Content higher than 1.0% (mass fraction) but not more than 20% (mass fraction) of each ingredient hundred Content of the packaging, label or interstitial marked deviation value is not more than 1.0% (mass fraction) [see 9.1a)]. 5.2 harmful ingredients 5.2.1 recognized harmful ingredients According to this standard uses, nickel, cadmium and beryllium specified as harmful ingredients. 5.2.2 limit values of harmful components cadmium and beryllium Content of cadmium or beryllium metal material is not more than 0.02% (mass fraction). 5.2.3 manufacturers label their nickel content Tolerance If the metal material nickel content greater than 0.1% (mass fraction), should be in the package [see 9.1n)] accompanying documents and packaging, labeling Or interstitial [see 10.2f)] mark on this content and accuracy of 0.1% (mass fraction). The mass fraction of nickel content should not exceed 9.1n) and 10.2f) specified value. 5.3 biocompatibility Biocompatible see the introduction guide. 5.4 Mechanical properties 5.4.1 Overview 8.3.2 shall be tested. After the recommended processing (for example. casting, air-cooled, machining), and after porcelain bake metallic material (if applicable) should be consistent Table 1 requirements. Recommended with or without ceramic finishes metal material in both metallurgical state should meet the requirements. If the manufacturer recommended heat treatment [9.2c)], the manufacturer's instructions when used in accordance with the material under heat treatment conditions should Compliance with this requirement. If the metal material is suitable for metallurgical state of more than one (by one of the production process), it might have a different classification (according to Table 1), it should provide the highest type of use in each condition of use. Table 1 Mechanical properties of metallic materials Types of 0.2% non-proportional extension Strength Rp0.2/MPa Least The Elongation /% Least Young's modulus/GPa Least 0 - - - 18018-- 218010-- 32705-- 43602-- 5.4.2 0.2% non-proportional extension strength 5.4.2.1 compliance determination Reference 9.lb) Category type specified. If the six samples tested in the first group there are four, five or six meet the 0.2% non-proportional extension strength requirements, it is considered The metal material to meet the requirements. If the six samples tested in the first group there are two or fewer samples meet the 0.2% non-proportional extension strength requirements, it is considered The metal material does not meet the requirements. Note 1. Make two sets of samples, each 6 (see 7.3.1). One set for the Group 1 test. If desired, you can replace the first set with a second set of samples The part of the sample. The first two sets of the remaining sample as a sample group of the second trial. Note 2. In these terms, the number of samples if the total number of samples tested by subtracting break inspect discarded equal to 6, it means reached the completion of the first test group The number of specimens required six requirements (ie, including the replacement of the total number of sample specimens). If the six samples tested in the first group there are three or four samples according to 8.3.2 is discarded, and replaced with a second set of samples, then 12 Samples are to be tested. At least eight of the sample results in line with 0.2% of non-proportional extension strength requirements in order that the metal sheet Expected to meet the requirements. If the six samples tested in the first group there are three samples meet the 0.2% non-proportional extension strength requirements, then the first two sets of the remaining All samples should be tested. If the second test group has five or six samples in line with 0.2% of non-proportional extension strength requirements, is recognized For metallic materials meet the requirements. Note 3. According to this criteria, if the first group test samples according to a discarded fracture after checking (8.3.2), and a sample with a second set of alternatives that What of the second set all the remaining five samples should meet the requirements. Note. There can be only one sample can be used to replace the first group of test samples. If the six samples tested in the first group there are three samples meet the 0.2% non-proportional extension strength requirements and test group 2 There are four or fewer samples meet the 0.2% non-proportional extension strength requirements, it is considered that the metal material does not meet the requirements. 5.4.2.2 mean 0.2% non-proportional extension strength of the average of the accompanying documentation and packaging [see 9.1c)] as shown in the deviation value should not exceed 10%. 5.4.3 percentage elongation after fracture 5.4.3.1 compliance determination Reference 9.1b) Category type specified. If the six samples tested in the first group in line with 0.2% of non-proportional extension strength requirements of four, five or six samples in line with Requirements of the Elongation of the metal material is considered to meet the requirements of the Elongation of. If the six samples tested in the first group there are two or fewer samples to meet the requirements of the Elongation, it is believed that the metal material is not Meet the requirements of the Elongation of. Note 1. Make two sets of samples, each 6 (see 7.3.1). One set for the Group 1 test. If desired, you can use the first two sets of the first set of alternate sample The part of the sample. The first two sets of the remaining samples constituting the second test group. Note 2. In these terms, the number of samples if the total number of samples tested by subtracting break inspect discarded equal to 6, it means that the first group completed the trial test The number of specimens is 6 (ie, the total number of samples included in the sample alternative). If the six samples tested in the first group there are three or four samples according to 8.3.2 is discarded, and replaced with a second set of samples, then 12 Samples are to be tested. If they meet the 0.2% non-proportional extension strength required at least eight samples are also consistent with the Elongation of Requirements, the metal material is considered to meet the requirements of the Elongation of. If the six samples tested in the first group in line with 0.2% of non-proportional extension strength requirements of the three samples is also consistent with the Elongation Requirements, then the rest of the second set of all samples should be tested. If the second test group of five or six samples comply Elongation Rate and 0.2% non-proportional extension strength requirements, the metal material is considered to meet the requirements of the Elongation of. If the second test group The five or six samples meet the requirements of the Elongation, but does not meet the 0.2% non-proportional extension strength requirements, it is considered the gold Metallic material does not meet the requirements of the Elongation of. Note 3. According to this criteria, if the first group test samples according to a discarded fracture after checking (8.3.2), and a sample with a second set of alternatives that What of the second set all the remaining five samples should meet the requirements. Note. There can be only one sample can be used to replace the first group of test samples. If the six samples tested in the first group there are three samples meet the requirements of the Elongation, and Group 2 Test 4 or more Less consistent with the Elongation of the sample requirements, that the metal material does not meet the requirements of the Elongation of. 5.4.3.2 mean The average percentage elongation after fracture should be greater than shown in the accompanying documentation package value of 70%, but not less than the minimum value of the type [see 9.1d)]. 5.4.4 Young's modulus 5.4.4.1 5 type material compliance determination reference 9.1b) specified category type. If the six samples tested in the first group, in line with 0.2% of non-proportional extension strength and elongation after fracture required four, five or 6 samples in line with the requirements of the Young's modulus, it is considered that the metal material meets the requirements of the Young's modulus. If the six samples tested in the first group, there are two or fewer samples meet the 0.2% non-proportional extension strength and elongation after fracture Requirements, even if they meet the requirements of the Young's modulus, but also that the metallic material does not meet the requirements of the Young's modulus. Note 1. Make two sets of samples, each 6 (see 7.3.1). One set for the Group 1 test. If desired, you can use the first two sets of the first set of alternate sample The part of the sample. The first two sets of the remaining samples constituting the second test group. Note 2. In these terms, the number of samples if the total number of samples tested by subtracting break inspect discarded equal to 6, it means that the first group completed the trial test The number of specimens is 6 (ie, the total number of samples included in the sample alternative). If the six samples tested in the first group there are three or four samples according to 8.3.2 are discarded, while the second set of samples with replacement, then 12 Samples are to be tested. If it meets the 0.2% non-proportional extension strength, and at least eight samples of the Elongation requirements are in compliance Young's modulus of the requirements, the metal material is considered to meet the requirements. If the six samples tested in the first group, in line with 0.2% of non-proportional extension strength and elongation after fracture required three samples also breaks Closing the Elongation requirements, then the remaining 2 sets all samples should be tested. If the second test group of five or six samples were In line with Young's modulus, 0.2% of the requirements of non-proportional extension strength and elongation after fracture, the metal material is considered to be in line with Young's modulus Demand; otherwise, the metal material that does not comply with the requirements of the Young's modulus. Note 3. According to this criteria, if the first group test samples according to a discarded fracture after checking (8.3.2), a sample replacement by the first two sets, then 2 sets all the remaining five samples should meet the requirements. Note. There can be only one sample can be used to replace the first group of test samples. 5.4.4.2 mean Deviation values shown on the Young's modulus of the average value of the package accompanying document should not exceed ± 10% [see 9.1e)]. 5.5 Density Deviation values shown in the accompanying documentation and packaging density metallic materials should not exceed ± 5% [see 9.1f)]. 5.6 corrosion resistance 8.5 when tested in accordance with the metal material at (37 ± 1) ℃, (7.0 ± 0.1) d is released within the specified solution (see 8.5.4) total Metal ions should not exceed 200μg/cm2. Metallic materials using the recommended processing techniques (for example. casting, air-cooled, machining) and after the sintering procedures (if applicable) should be Meet the above requirements. Recommended for use with or without ceramic finishes metal material in both metallurgical state should meet this requirement. 5.7 tarnish Packaging accompanying document "information", the statement has "tarnish resistance" product for this requirement. Exposure to the specified dark environment (see 8.6), if only very slight color change, and by gently brushing can be easily removed Rust on the alloy composition, in the accompanying documents package can be described as "anti tarnish" [see 9.1g)]. After the recommended processing (for example. casting, air-cooled, machining), and after porcelain bake metallic material (if applicable) should be consistent The above-mentioned requirements. Recommended with or without ceramic finishes metal material in both metallurgical state should meet this requirement. 5.8 solidus and liquidus temperature (alloys) or melting point (commercially pure metal) For the solidus temperature of the alloy is less than or equal to 1200 ℃, as shown on the accompanying documents solidus and liquidus temperature and packaging value The deviation should be no greater than ± 20 ℃ [see 9.1h)]. For the alloy solidus temperature greater than 1200 ℃, the deviation value shown on the accompanying documents solidus and liquidus temperature and packaging Should not exceed ± 50 ℃ [see 9.1h)]. For the melting point of less than or equal to 1200 ℃ commercial pure metal, the melting point of the deviation should not exceed ± 20 ℃; a melting point greater than Business 1200 ℃ of pure metal, the melting point of the deviation should not exceed ± 50 ℃. 5.9 coefficient of linear expansion This requirement only applies to metal - ceramic restorations with a metallic material. Deviation values shown on the accompanying documents and the linear expansion coefficient of metal packaging materials should be less than 0.5 × 10-6K-1 [see 9.1i)]. Note. The linear expansion coefficient measured value with the manufacturer should be used for quality control values are consistent. Meet this requirement does not guarantee any particular alloy and the ceramic phase match. 5.10 Information, descriptions and identification All the requirements in Chapter 9 and Chapter 10 provisions should be properly introduced. If you need detailed description or recommendation, these instructions And recommendations should be sufficient to achieve its purpose.

6 Sampling

The sample size should be able to meet the required 7.3 Preparation of samples, and the samples should be taken from the same batch. In addition, samples and packaging materials should be used Check 8.1 requirements.

7 Sample Preparation

7.1 Overview In accordance with the manufacturer's instructions (see 9.2) to prepare all samples. If the sample is casting sprue should be carefully separated and removed all the tumor and casting burrs. Replace all existing visual defects of samples. 7.2 Heat Treatment 7.2.1 Overview In the metallurgical state in line with the intended use of sample testing of metallic materials for compliance. 7.2.2 the manufacturer's recommended instructions for use of heat-treating metal material If the manufacturer recommended heat treatment [see 9.2c)], should be at the manufacturer specified in the instructions of the heat treatment conditions deal with. 7.2.3 metal - ceramic prosthesis with a metal material In the simulation test program after the following porcelain. Under simulated porcelain powder recommended maximum melting temperature of the oxidation process and attached four porcelain program [see 9.1k)]. Each ceramic oxide and si...

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