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YY/T 0988.1-2016 English PDF

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YY/T 0988.1-2016: Coatings of surgical implants--Part 1: Cobalt-28 chromium-6 molybdenum powder
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YY/T 0988.1-2016English179 Add to Cart 3 days [Need to translate] Coatings of surgical implants--Part 1: Cobalt-28 chromium-6 molybdenum powder Valid YY/T 0988.1-2016

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Basic data

Standard ID YY/T 0988.1-2016 (YY/T0988.1-2016)
Description (Translated English) Coatings of surgical implants--Part 1: Cobalt-28 chromium-6 molybdenum powder
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 9,956
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
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/T 0988.1-2016: Coatings of surgical implants--Part 1: Cobalt-28 chromium-6 molybdenum powder

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Coatings of surgical implants - Part 1. Cobalt-28 chromium-6 molybdenum powder ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical Implant Coatings Part 1. cobalt-28 chromium-6 molybdenum powder Coatingsofsurgicalimplants-Part 1. 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 meaning and application 1 4 manufacturing method 1 5 Chemical requirements 1 6 particle size 3 7 cleanliness 3 Appendix A (informative) Basic principles 4 Appendix B (informative) Biocompatibility 5 Reference 6

Foreword

YY/T 0988 "Surgical Implant Coating" is divided into the following sections. - Part 1. cobalt - 28 chromium - 6 molybdenum powder; - Part 2. Titanium and titanium - 6 - 4 - vanadium alloy powders; - Part 3 to Part 10. (reserved); - Part 11. Test methods for tensile test of calcium phosphate coating and metal coating; Part 12. Test methods for calcium phosphate coating and metal coating shear test; - Part 13. Test methods for shear and bending fatigue of calcium phosphate, metal and calcium phosphate/metal composite coatings; - Part 14. Method for evaluation of porous coating bodies; Part 15. Test method for abrasion resistance of metallic thermal sprayed coatings. This part is part 1 of YY/T 0988. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section uses the re-drafting method for reference ASTMF1377-2008 "Standard Specification for Coated-Co-2 + Chromium-6 Molybdenum Powder for Orthopedic Implant Coatings Fan "system. The technical differences between this section and ASTM F1377-2008 are as follows. --- on the normative reference documents, this part made a technical differences in the adjustment, delete the ASTMF1377-2008 in the 2.2 And 2.3 to meet the technical conditions of our country. - Remove Chapter 3, Chapter 9, Chapter 10, Chapter 11 of ASTM F1377-2008. 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 section is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110). This part of the drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration Bureau of Medical Device Technical Review Center. This part of the main drafters. Li Yuan, Fu Ruizhi, Dong Shuangpeng, Liu Bin, Guo Xiaolei. Surgical Implant Coatings Part 1. cobalt-28 chromium-6 molybdenum powder

1 Scope

YY/T 0988 This section specifies the cobalt-28 chromium-6 molybdenum alloy powder for the formation of a coating on a cobalt-28 chromium-6 molybdenum implant Claim. The powder specified in this section may be formed by a sintering process or a thermal spraying process. This section specifies the requirements of the powder and does not apply to the performance of the powder made of the coating.

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. ASTMB214 metal powder sieving standard test method (Testmethodforsieveanalysisofmetalpowders) Standard Practice for the Sampling of ASTMB215 Metal Powders (Practicesforsamplingmetalpowders) ASTME11 Specification for Wire Mesh Screening (Specificationforwireclothandsievesfortestingpurposes) Standard Test Method for Chemical Analysis of ASTME354 High Temperature Steel, Electrical Steel, Magnet and Other Similar Iron, Nickel and Cobalt Alloys (Test methodsforchemicalanalysisofhigh-temperature, electrical, magnetic, andothersimilariron, nickel, andcobaltaloys)

3 meaning and application

The coating made of metal powder has been widely used in improving the adhesion of tissue and non-cement fixed joint prosthesis. Such coating also Can improve the adhesion of acrylic resin bone cement and prosthesis. This section specifies the specific requirements for the coating of metallic powders. Principle and health See Annex A and Appendix B for compatibility.

4 manufacturing method

The powder may be subjected to a plasma rotary electrode method, an inert gas atomization method or other method capable of producing a powder satisfying the requirements of this part.

5 Chemical requirements

5.1 The raw material thermal analysis results of the powder shall be in accordance with Table 1.

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