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YY/T 0019.1-2011 PDF English

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YY/T 0019.1-2011: Implants for surgery. Intramedullary nailing systems. Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
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YY/T 0019.1: Historical versions

Std IDVersionUSDBuyDeliver [PDF] inTitle (Description)
YY/T 0019.1-2011English154 Add to Cart 3 days [Need to translate] Implants for surgery. Intramedullary nailing systems. Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
YY 0019-2002English439 Add to Cart 4 days [Need to translate] Implants for osteosynthesis--Metallic intramedullary nailing systems
YY 0019-1990English559 Add to Cart 4 days [Need to translate] (Intramedullary nail)

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Basic data

Standard ID YY/T 0019.1-2011 (YY/T0019.1-2011)
Description (Translated English) Implants for surgery. Intramedullary nailing systems. Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 8,885
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Older Standard (superseded by this standard) YY 0019-2002
Quoted Standard YY/T 0605.5; ISO 5832-1
Adopted Standard ISO 5837-1-1985, 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 orthopedic surgical trefoil cross-section or V-shaped intramedullary nail primary and mating dimensions. This section also provides for removing the hook size, and recommended use with healthy nails guide pin diameter.

YY/T 0019.1-2011: Implants for surgery. Intramedullary nailing systems. Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section





---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 1. Intramedullary nails with cloverleaf or V-shaped cross-section ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Partially replaced YY 0019-2002 Surgical implant intramedullary nail system Part 1. trilobal cross section or V-shaped nail Part 1. IntramedularynailswithcloverleaforV-shapedcross-section (ISO 5837-1. 1985, IDT) Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

YY/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 1. 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". Business enterprises can develop the product in accordance with this standard and YY 0341 "osteosynthesis with non-active surgical implants metal General technical conditions" Industry standards. 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 5837-1. 1985 "surgical implant intramedullary nail system - Part 1. cross-section of three Leaf or V-shaped nail. " Correspondence between the consistency of the standards of international documents and normative references of the following documents. • GB 4234 (ISO 5832-1.1997, MOD). 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 State Food and Drug Administration. 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. Makin bamboo, Jiang Xi, Zhang Wenhui, Jiaoyong Zhe, Furui Zhi. Surgical implant intramedullary nail system Part 1. trilobal cross section or V-shaped nail

1 Scope

YY/T 0019 provisions of this part of the orthopedic surgical trilobal cross section or V-shaped intramedullary nail primary and mating dimensions. Headquarters Points also provides for removing the hook size, and recommended with the guide pin diameter intramedullary nail use.

2 Normative references

The 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. 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 5832-1 Implants for surgery - Metallic materials - Part 1. Forged Stainless Steel (Implantsforsurgery-Metalicma- terials-Part 1. Wroughtstainlesssteel)

3 A Type

Cross-section straight nail trefoil shown in Figure 1, Table 1. Millimeters ab3 can be extended to the entire length of the nail. In view of the functional requirements, b3 dimensions should not exceed their respective mating guide pin diameter used (see Chapter 8). figure 1 ...

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