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YY/T 0812-2010: Implants for surgery. Metallic implantable strands and cables
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Implants for surgery. Metallic implantable strands and cables
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YY/T 0812-2010
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Basic data | Standard ID | YY/T 0812-2010 (YY/T0812-2010) | | Description (Translated English) | Implants for surgery. Metallic implantable strands and cables | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,198 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 228; YY/T 0605.5; YY/T 0605.6; YY/T 0606.7; YY/T 0640-2008; ISO 5832-2; ISO 5832-3; ISO 5832-11; ASTM F86; ASTM F562; ASTM F1058; ASTM F1314 | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the criteria for surgical implants of metal cables and cable materials, dimensional tolerances, structural and mechanical properties. This standard is used to aid specific cables and cable standards, especially for high load carrying cables and ropes, but not for the structure, material or performance in all possible variations. | YY/T 0812-2010: Implants for surgery. Metallic implantable strands and cables---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 implantable strands and cables
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical implants for metal cables and cables
2010-12-27 release
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the re-drafting method to refer to ASTM F2180-2002 "Standard Requirements for Metallic Cables and Cables for Surgical Implants"
prepared by.
The technical differences between this standard and ASTMF2180-2002 are as follows.
--- on the normative reference documents, this standard has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation
The situation is reflected in Chapter 2, "Normative references", as follows.
● replace GBME8 with GB/T 228;
● Replacement of ASTMF90 with YY/T 0605.5;
● instead of ASTM F136 with ISO 5832-3;
● instead of ASTM F138 with ISO 5832-1;
● instead of ASTM F1295 with ISO 5832-11;
● instead of ASTM F1341 with ISO 5832-2;
● YY/T 0640-2008, YY/T 0605.6, YY/T 0605.7;
● The ASQC1, MIL-DTL-83420J, MIL-DTL-83420/1B, MIL-DTL-83420/2B are deleted.
- Chapter 5, "Order Information", Chapter 13, "Certificates", Chapter 14, "Quality Procedures Requirements," and Chapter 15, "Keywords", have been removed;
- Added Chapter 10, "Sterilization", Chapter 11, "Packaging" and Chapter 12, "Information Provided by the manufacturer."
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 standard by the National Surgical Implantation and Orthopedic Equipment Standardization Technical Committee Materials and Orthopedic Implants Subcommittee (SAC /
TC110/SC1).
The drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Zhang Chen, Zhang Lu, Li Yuan.
Surgical implants for metal cables and cables
1 Scope
This standard specifies the material, dimensional tolerances, structural and mechanical properties of standard metal cables and cables for surgical implants.
This standard is used to assist in the development of specific cable and cable standards, especially for high load-bearing cables and cables, but not for structural,
Material or performance may occur in all changes.
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.
GB/T 228 Test method for room temperature tensile testing of metallic materials (GB/T 228-2002, eqvISO 6892..1998)
YY/T 0605.5 Surgical implants - Metallic materials - Part 5. Forged cobalt - chromium - tungsten - nickel alloys (YY/T 0605.5-2007,
ISO 5832-5..2005, IDT)
YY/T 0605.6 Surgical implants - Metallic materials - Part 6. Forged cobalt - nickel - chromium - molybdenum alloys (YY/T 0605.6-2007,
ISO 5832-6..1997, IDT)
YY/T 0605.7 Surgical implants - Metallic materials - Part 7. Cuts and cold - worked cobalt - chromium - nickel - molybdenum - iron alloys
(YY/T 0605.7-2007, ISO 5832-7..1994, IDT)
YY/T 0640-2008 General requirements for passive surgical implants (ISO 14630..2005, IDT)
ISO 5832-1 Surgical implants - Metallic materials - Part 1. Implantsforsurgery - Metalicma -
terials-Part 1. Wroughtstainlesssteel)
ISO 5832-2 Surgical implants - Metallic materials - Part 2. Implantsforsurgery - Metalic
materials-Part 2. Unaloyedtitanium)
ISO 5832-3 Surgical implants - Metallic materials - Part 3. Forged titanium - 6 - 4 - vanadium alloys (Implantsforsurgery -
Metalicmaterials-Part 3. Wroughttitanium6-aluminium-vanadiumaloy)
ISO 5832-11 Surgical implants - Metallic materials - Part 11. Forged titanium - 6 - 7 - niobium alloys (Implantsforsurgery -
Metalicmaterials-Part 11. Wroughttitanium6-aluminium 7-niobiumaloy)
ASTMF86 Metal surgical implants for surface treatment and labeling (Practiceforsurfacepreparationandmarkingof
metalicsurgicalimplants
Standard Specification for Forged Cobalt -35 Nickel-20 Chrome-10 Molybdenum Alloy for Surgical Implants ASTM F562 (UNS R30035)
(Specificationforwrought35Cobalt-35Nickel-20Chromium-10Molybdenumaloyforsurgicalimplant
applications (UNSR30035))
Standard Specification for Forged Cobalt-Chromium-Nickel-Molybdenum-Ferroalloy for Surgical Implants, ASTM F1058 (Specificationforwrought
40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenumaloywireandstripforsurgicalimplantappli-
cations
ASTM F1314 surgical implants forged high nitrogen 22 chrome -13 nickel-5 manganese-2.5 molybdenum stainless steel alloy bar and wire standard
(UNS S20910) (Specification for wrought nitrogenous 22 Chromium-13 Nickel-5
Manganese-2.5Molybdenumstainlesssteelaloybarandwireforsurgicalimplants (UNSS20910))
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