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YY 0605.12-2016 English PDF

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YY 0605.12-2016: Implants for surgery. Metallic materials. Part 12: Wrought cobalt-chromium-molybdenum alloy
Status: Valid

YY 0605.12: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0605.12-2016English119 Add to Cart 3 days [Need to translate] Implants for surgery. Metallic materials. Part 12: Wrought cobalt-chromium-molybdenum alloy Valid YY 0605.12-2016
YY 0605.12-2007English239 Add to Cart 3 days [Need to translate] Implants for surgery. Metallic materials. Part 12: Wrought cobalt-chromium-molybdenum alloy Obsolete YY 0605.12-2007

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Basic data

Standard ID YY 0605.12-2016 (YY0605.12-2016)
Description (Translated English) Implants for surgery. Metallic materials. Part 12: Wrought cobalt-chromium-molybdenum alloy
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 6,62
Date of Issue 2016-01-26
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0605.12-2007
Quoted Standard ISO 643; ISO 6892-1
Adopted Standard ISO 5832-12-2007, IDT
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements for two types of surgical implants, the forged cobalt 28 chromium 6 molybdenum alloy. This standard applies to the use of forged bar and wire for surgical implants.

YY 0605.12-2016: Implants for surgery. Metallic materials. Part 12: Wrought cobalt-chromium-molybdenum alloy


---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 12. Wrought cobalt-chromium-molybdenum alloy ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard YY 0605.12-2016/ISO 5832-12..2007 Replacing YY 0605.12-2007 Surgical implants Part 12. forged cobalt - chromium - molybdenum alloys Part 12. Wroughtcobalt-chromium-molybdenumaloy (ISO 5832-12..2007, IDT) 2016-01-26 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

The technical content of this section is mandatory. "Surgical Implants Metal Materials" is expected to be divided into 14 parts. - Part 1. Forged stainless steel (reserved); Note 1. At present this part is GB 4234-2003 "Stainless steel for surgical implants" (ISO 5832-1..1997, MOD); - Part 2. Pure titanium; - Part 3. forged titanium 6 aluminum 4 vanadium alloy; - Part 4. Cast cobalt - chromium - molybdenum alloy; Note 2. At present this part is GB 17100-1997 "cast cobalt chromium molybdenum alloy for surgical implants" (ISO 5832-4..1996, MOD); - Part 5. Forged cobalt - chromium - tungsten - nickel alloy; - Part 6. forged cobalt - nickel - chromium - molybdenum alloy; - Part 7. malleable and cold - worked cobalt - chromium - nickel - molybdenum - ferrous alloys; - Part 8. Forged cobalt - nickel - chromium - molybdenum - tungsten - ferroalloy; - Part 9. Forged high nitrogen stainless steel; - Part 10. (reserved); - Part 11. Forged titanium - 6 - 7 - niobium alloy (reserved); - Part 12. Forged cobalt - chromium - molybdenum alloy; - Part 13. (reserved); - Part 14. forged titanium 15 molybdenum 5 zirconium 3 aluminum alloy. This section is part 12 of YY 0605. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY 0605.12-2007 "Surgical Implants Metal Materials Part 12. Forged Cobalt-Chromium-Molybdenum Alloys", and YY 0605.12-2007 compared to the editorial changes, the main technical changes are as follows. --- made a change to the scope and added Note 2; Table 1 according to the different content of C is divided into low-carbon alloy and high-carbon alloy two; --- increase the mechanical properties of the principle of re-inspection; The mechanical properties of Table 2 have been modified. This part uses the translation method equivalent to ISO 5832-12..2007 "Surgical Implants Metal Materials Part 12. Forged Cobalt-Chromium- Molybdenum alloy ", including its errand ISO 5832-12..2007/Cor.1..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. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Baxiao material high-tech Co., Ltd. This part of the main drafters. Li Yuan, Ma Jinzhu, Fu Ruizhi, Song Duo, Liang Fanghui, Li Tong. This part was first released in January.2007. YY 0605.12-2016/ISO 5832-12..2007

Introduction

There is currently no known surgical implant material that has been shown to be completely non-toxic to the human body, but the materials covered by this standard In long-term clinical applications it has been shown that the expected level of biological response is acceptable if applied properly. YY 0605.12-2016/ISO 5832-12..2007 Surgical implants Part 12. forged cobalt - chromium - molybdenum alloys

1 Scope

This part of YY 0605 specifies the requirements for two surgical implants for forged cobalt 28 chromium 6 molybdenum alloys. This section applies to forged rods and wire for surgical implants. Note 1. The mechanical properties of the samples taken from the finished product may not necessarily comply with the provisions of this section. Note 2. The high carbon alloy produces a distinct carbide distribution structure that can be adjusted during the production of the bar or during the subsequent heat treatment of the finished product. The distribution of carbides in the product is outside the scope of this section.

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. Determination of apparent grain size by ISO 643 steel micrograph (Steels-Micrographicdeterminationoftheapparentgrain size) ISO 6892-1 Metallic materials - Tensile testing - Part 1. Room temperature test method (Metalicmaterials - Tensiletesting - Part 1. Methodoftestatroomtemperature

3 chemical composition

According to the method specified in Chapter 6 of the representative alloy samples for melting analysis, the chemical composition should be consistent with the provisions of Table 1. Table 1 Chemical composition element Chemical composition (mass fraction) /% Alloy 1 (low carbon) alloy 2 (high carbon) Chromium (Cr) Molybdenum (Mo) Iron (Fe) Manganese (Mn) Silicon (Si) Carbon (C) Nickel (Ni) Nitrogen (N) Cobalt (Co) 26.0 to 30.0 5.0 ~ 7.0 ≤0.75 ≤1.0 ≤1.0 ≤0.14 ≤1.0 ≤ 0.25 Matrix 26.0 to 30.0 5.0 ~ 7.0 ≤0.75 ≤1.0 ≤1.0 0.15 to 0.35 ≤1.0 ≤ 0.25 Matrix YY 0605.12-2016/ISO 5832-12..2007

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