YY 0605.9-2015Implants for surgery—Metallic materials - Part 9: Wrought high nitrogen stainless steel (English PDF)

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 °C 30min" replaced by the "675 °C 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".

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.

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.