YY/T 0019.2-2011 English PDFUS$94.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0019.2-2011: Implants for surgery. Intramedullary nailing systems. Part 2: Medullary pins Status: Valid
Basic dataStandard ID: YY/T 0019.2-2011 (YY/T0019.2-2011)Description (Translated English): Implants for surgery. Intramedullary nailing systems. Part 2: Medullary pins Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 5,521 Date of Issue: 2011-12-31 Date of Implementation: 2013-06-01 Older Standard (superseded by this standard): YY 0019-2002 Quoted Standard: GB/T 321; GB 4234; YY/T 0605.5; ISO 3651-2 Adopted Standard: ISO 5837-2-1980, IDT Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the character to use nail orthopedic implant main dimensions and requirements. YY/T 0019.2-2011: Implants for surgery. Intramedullary nailing systems. Part 2: Medullary pins---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.Intramedullary nailing systems.Part 2. Medullary pins ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Partially replaced YY 0019-2002 Surgical implant intramedullary nail system Part 2. intramedullary nail Part 2. Medularypins (ISO 5837-2. 1980, IDT) Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued ForewordYY/T 0019 "surgical implant intramedullary nail system" is divided into two parts. --- Part 1. trilobal cross section or V-shaped intramedullary nail; --- Part 2. intramedullary nail. This section YY/T 0019 Part 2. This section drafted in accordance with GB/T 1.1-2009 given rules. From "surgical implant intramedullary nail system" from the implementation date, replace and repeal YY 0019-2002 "metal implant intramedullary osteosynthesis Needle ", may, according to this standard and YY 0341" to develop the products of enterprises with non-active surgical osteosynthesis metal implants general technical conditions " standard. The main difference between "surgical implant intramedullary nail system" and YY 0019-2002 "osteosynthesis implant intramedullary nail metal" as follows. --- The standard by "trilobal cross-section of the intramedullary nail" instead YY 0019-2002 in "Plum needle"; --- The standard by "intramedullary nail" instead YY 0019-2002 of "crochet"; --- This standard adds the V-nail type, delete YY 0019-2002 double rectangular flexible wire, flexible wire circular arcuate Needle, curved needle, needle and wing needle, such as several types of intramedullary nail; --- Compared with YY 0019-2002, the provisions of this standard intramedullary nail and needle the size of the relevant parts in more detail; --- This standard adds and remove the hook with intramedullary nail used in the respective guide pin size. This section uses the translation method identical with ISO 5837-2. 1980 "surgical implant intramedullary nail system Part 2. intramedullary nail." This part of ISO 5837-2. 1980 technical differences are as follows. --- On normative references, this part has been adjusted technical differences, in order to adapt our technical conditions, the adjusted situation Focus is reflected in the status of Chapter 2, "Normative references", the specific adjustments are as follows. ● with GB 4234 instead of ISO 5832-1; ● with YY/T 0605.5 instead of ISO 5832-5; ● The latest version of the ISO (ISO 3651.1998) 3651-2 replaces the ISO 3651-2. 1976, the standard name be adjusted accordingly; ● increase the GB/T 321, and replaces the ISO 3. --- Delete international standards foreword. 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 of the National Surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC / TC110/SC1) centralized. This section is drafted. Tianjin State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Jiang Xi, Ma bamboo, Zhang Wenhui, Jiaoyong Zhe, Furui Zhi. Surgical implant intramedullary nail system Part 2. intramedullary nail1 ScopeThis section YY/T 0019 specifies the main dimensions of orthopedic implants and requirements of the intramedullary nail.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 321 priority number and priority number system (GB/T 321-2005, ISO 3. 1973, IDT) GB 4234 stainless steel surgical implants (GB 4234-2003, ISO 5832-1.1997, MOD) YY/T 0605.5 surgical implants of metallic materials - Part 5. Wrought cobalt - chromium - tungsten - nickel alloy (YY/T 0605.5-2007, ISO 5832-5.2005, IDT) ISO 3651-2 Determination of stainless steel to intergranular corrosion - Part 2. Ferritic, austenitic and ferritic - austenitic (duplex) stainless Steel in sulfuric acid medium corrosion test (Determinationofresistancetointergranularcorrosionofstainless steels-Part 2. Ferritic, austeniticandferritic-austenitic (duplex) stainlesssteels-Corrosiontestin mediacontainingsulfuricacid)3 MaterialsIntramedullary nail may be consistent with GB 4234 stainless steel or in compliance with YY/T 0605.5 wrought cobalt - chromium - tungsten - nickel alloy (cold) manufacture. According to the above requirements, the manufacturer of the intramedullary nail material should comply with GB 4234 or YY/T 0605.5 prescribed use.4 manufacturing methodIntramedullary nail should be used cold-drawn or cold manufacturing process, shall not be welded. If you need some parts of stainless steel intramedullary nail re plastic Shape, only when the whole of the final product to meet the ISO 3651-2 predetermined intergranular corrosion test before allowing the product locally heated.5 SurfaceThe outer surface should be free of burrs, scratches and other visible defects. Special attention should be part of the intramedullary nail bending r surface quality.6 DimensionsThe size of the intramedullary nail shown in Figure 1, shall comply with the requirements in Table 1. ...... |
