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YY/T 0345.2-2014 PDF English

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YY/T 0345.2-2014: Implants for surgery. Skeletal pins and wires. Part 2: Steinmann skeletal pins. Dimensions
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YY/T 0345.2-2014English114 Add to Cart 3 days [Need to translate] Implants for surgery. Skeletal pins and wires. Part 2: Steinmann skeletal pins. Dimensions

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Basic data

Standard ID YY/T 0345.2-2014 (YY/T0345.2-2014)
Description (Translated English) Implants for surgery. Skeletal pins and wires. Part 2: Steinmann skeletal pins. Dimensions
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 6,647
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Older Standard (superseded by this standard) YY 0345-2002
Adopted Standard ISO 5838-2-1991, IDT
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to Steinmann pin. This Standard specifies the Steinmann pin length, diameter size requirements, and recommended several cutting-edge type, according to the insert mode, the insertion site (eg, cortical or cancellous bone) different b

YY/T 0345.2-2014: Implants for surgery. Skeletal pins and wires. Part 2: Steinmann skeletal pins. Dimensions




---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.Skeletal pins and wires.Part 2. Steinmann skeletal pins.Dimensions ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Partially replaced YY 0345-2002 Implants for surgery - Metal bone needle Part 2. Steinmann pin size Implantsforsurgery-Skeletalpinsandwires-Part 2. Steinmannskeletal pins-Dimensions (ISO 5838-2.1991, IDT) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

YY/T 0345 "metal surgical implants bone needles" is divided into three sections. --- Part 1. Material and mechanical performance requirements; --- Part 2. Steinmann pin size; --- Part 3. Kirschner. This section YY/T Section 20345 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This portion instead of YY 0345-2002 "osteosynthesis implant metal spicules." --- YY 0345-2002 metal spicules only stainless steel materials, the new standards also include titanium, titanium alloys and cobalt-based materials, Therefore, a wider scope of the new standard. --- YY 0345-2002 metal spicules more general type, and the new standards are divided into specific Steinmann pin and Kirschner, distinguish more To clarify. --- YY 0345-2002 only provides the tensile strength of the metal bone pins, and the new standard, in accordance with the material, the size of different refinement Mechanical properties of metal spicules requirements and increases the requirements of the Elongation of. --- YY 0345-2002 only provides metal bone needles size range, the new standard in size more detailed, and increased tolerance. This section uses the translation method identical with ISO 5838-2.1991 "spicules metal surgical implants - Part 2. Steinmann pin ruler Inch". Since the implementation of this section, instead of YY 0345-2002 "osteosynthesis implant metal bone needle" in the appropriate section. 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 China 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 State Food and Drug Pipe Authority for Medical Device Evaluation Center. The main drafters of this section. Ma Chun Bao, Zhang Chen, Liu Bin, Terence Chang. Implants for surgery - Metal bone needle Part 2. Steinmann pin size

1 Scope

YY/T 0345 provisions of this part of the Steinmann pin size. Materials and mechanical performance requirements see YY/T 0345.1. Note. According to insertion, the insertion site (for example, cortical or cancellous bone) different bone needle tip can be designed into different types.

2 Dimensions

Dimensions shall comply with Figs. 1 to 5 and specified in Table 1 to Table 3.

1 Steinmann pin main dimension drawing

Table 1 Steinmann pin main dimensions in millimeters diameter d 0-0.048 length l ± 2 3.5 4.5 125 to 300

3 ends

3.1 General One end of spicules should tip, the other side should be in line with A type shown in 3.2, to any type B or type shown in Figure 3.3 C 3.4 of a type. Note. The recommended tip shown in Figure 2. Figure 2 Recommended Steinmann pin tip ...

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