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YY 0605.9-2015 English PDF

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YY 0605.9-2015: Implants for surgery. Metallic materials. Part 9: Wrought high nitrogen stainless steel
Status: Valid

YY 0605.9: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0605.9-2015English154 Add to Cart 3 days [Need to translate] Implants for surgery. Metallic materials. Part 9: Wrought high nitrogen stainless steel Valid YY 0605.9-2015
YY 0605.9-2007English399 Add to Cart 3 days [Need to translate] Implants for surgery. Metallic materials. Part 9: Wrought high nitrogen stainless steel Obsolete YY 0605.9-2007

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Basic data

Standard ID YY 0605.9-2015 (YY0605.9-2015)
Description (Translated English) Implants for surgery. Metallic materials. Part 9: Wrought high nitrogen stainless steel
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 8,815
Date of Issue 2015-03-02
Date of Implementation 2017-01-01
Older Standard (superseded by this standard) YY 0605.9-2007
Quoted Standard GB/T 10561-2005; GB/T 17505-1998; ISO 377; ISO 437; ISO 439; ISO 629; ISO 643; ISO 671; ISO 3651-2; ISO 6892; ISO 10714
Adopted Standard ISO 5832-9-2007, IDT
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State Food and Drug Administration
Summary This Standard specifies the requirements for high strength and good corrosion resistance of surgical implants with a nitrogen content of 0.25% to 0.50% of the parts are not the characteristics of Li and the appropriate test methods.

YY 0605.9-2015: Implants for surgery. Metallic materials. Part 9: Wrought high nitrogen stainless steel


---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.
Implants for surgery Metallic materials Part 9. Wrought high nitrogen stainless steel ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards YY 0605.9-2015/ISO 5832-9.2007 Replacing YY 0605.9-2007 Surgical implants of metallic materials Part 9. Forged high nitrogen stainless steel Part 9. Wroughthighnitrogenstainlesssteel (ISO 5832-9.2007, IDT) Issued on. 2015-03-02 2017-01-01 implementation China Food and Drug Administration released

Foreword

All technical content in this section is mandatory. YY 0605 "surgical implants of metallic materials" is expected to be divided into 14 parts. --- Part 1. Forged steel (reserve); Note 1. At present, the part of the GB 4234-2003 "by stainless steel surgical implants" (ISO 5832-1.1997, MOD). --- Part 2. titanium; --- Part 3. Forged titanium 6 aluminum 4 - vanadium alloy; --- Part 4. Cast cobalt - chromium - molybdenum alloy; Note 2. This is currently part of the GB 17100-1997 "surgical implants CoCrMo casting alloy" (eqvISO 5832-4.1996). --- Part 5. Wrought cobalt - chromium - tungsten - nickel alloy; --- Part 6. Wrought cobalt - nickel - chromium - molybdenum alloy; --- Part 7. malleable and cold cobalt - chromium - nickel - molybdenum - iron alloy; --- Part 8. Wrought cobalt - nickel - chromium - molybdenum - tungsten - iron alloy; --- Part 9. Forged high nitrogen stainless steel; .( --- Part 10 of reservation); --- Part 11. Forged Titanium-6 Aluminium -7 niobium alloy (reserve); --- Part 12. Wrought cobalt - chromium - molybdenum alloy; --- Section 13 .( reserve); --- Part 14. 15 forged titanium zirconium molybdenum 5 3 aluminum. This is Part 9 YY 0605 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This Part replaces YY 0605.9-2007 "Part 9 surgical implant metal material. Forged high nitrogen stainless steel," and YY 0605.9- Compared to 2007, the main technical changes are as follows. --- Corrosion test conditions before the "Heat 650 ℃ 30min" replaced by the "675 ℃ heating 1h". --- Increase the mechanical properties of steel bars moderate hardening and hardening of the two states. --- Annealed wire diameter of the first gear and the last delete a file. --- Remove Appendix A. This section uses the translation method identical with ISO 5832-9.2007 "Part 9 surgical implant metal material. Forged high nitrogen stainless steel". 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 part is proposed by the China Food and Drug Administration. This part of the National Surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized. This section is drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Air Materiel Biam high-tech Co., Ltd .. The main drafters of this section. Li Yuan, Fu Ruizhi, makin bamboo, platinum Fan, Liang Fanghui, Xiong Zhenguo. This section was first released in January 2007. YY 0605.9-2015/ISO 5832-9.2007

Introduction

Currently known surgical implant material has not been demonstrated to completely non-toxic side effects on the human body, but the material covered in this section Long-term clinical applications show that if applied appropriately, the expected level of biological response is acceptable. YY 0605.9-2015/ISO 5832-9.2007 Surgical implants of metallic materials Part 9. Forged high nitrogen stainless steel

1 Scope

YY 0605 This section specifies the requirements for high strength and good corrosion resistance of surgical implants with a nitrogen content of 0.25% to 0.50% Stainless steel features and the appropriate test methods. Note 1. The sample taken from the finished product, its mechanical properties may not have to abide by the provisions of this section. Note 2. The requirements for other stainless steel surgical implants ISO 5832-1.

2 Normative references

The following documents for the application of this document is essential. For cited documents with dates, only the dated edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document. GB/T 10561-2005 Steel - Determination of content of nonmetallic inclusions standards diagrams microscopic examination method (ISO 4967.1998, IDT) GB/T 17505-1998 Steel and steel products General technical delivery requirements (eqv, ISO 404.1992) ISO 377 Steel and steel products for mechanical testing location and sample preparation (Steelandsteelproducts-Locationand preparationofsamplesandtestpiecesformechanicaltesting) ISO 437 Determination of carbon steel and cast iron combustion gravimetric method the total content (Steelandcastiron-Determinationoftotalcarbon content-Combustiongravimetricmethod) Determination of silicon steel and cast iron ISO 439 gravimetric method the total content (Steelandiron-Determinationoftotalsiliconcontent- Gravimetricmethod) ISO 629 spectrophotometric determination of manganese steel and cast iron spectroscopic (SteelandCastiron-Determinationofmanganesecontent- Spectrophotometricmethod) ISO 643 steel microscopy determination of apparent grain size (Steel-Micrographicdeterminationoftheapparentgrainsize) ISO 671 Determination of sulfur content of steel and cast iron combustion titration method (SteelandCastiron-Determinationofsulphurcontent- Combustiontitrimetricmethod) Between ISO 3651-2 austenitic stainless steel grain measured corrosion - Part 2. added scrap copper sulfate/sulfate medium corrosive Test (Determinationofresistancetointergranularcorrosionofstainlesssteel-Part 2. Ferritic, austeniticand

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