YY/T 0119.2-2014 English PDF

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YY/T 0119.2-2014: Spinal implants. Components uesd in the surgical fixation of the spinal skeletal system. Part 2: Metallic spinal screws
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0119.2-2014	169	Add to Cart	3 days	Spinal implants. Components uesd in the surgical fixation of the spinal skeletal system. Part 2: Metallic spinal screws	Valid

Similar standards

YY 0118   YY/T 0119.1   YY/T 0119.4   YY 0117.1   YY 0117.2   YY/T 0119.3   

Basic data

Standard ID: YY/T 0119.2-2014 (YY/T0119.2-2014)
Description (Translated English): Spinal implants. Components uesd in the surgical fixation of the spinal skeletal system. Part 2: Metallic spinal screws
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 7,721
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Older Standard (superseded by this standard): YY 0119-2002
Quoted Standard: YY/T 0119.1-2014; YY/T 0119.5-2014; ASTM F543; ASTM F1839
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 internal spinal fixation implant anchoring element metal spine screws. This Standard specifies the metal spine screws classification, material and performance requirements.

YY/T 0119.2-2014: Spinal implants. Components uesd in the surgical fixation of the spinal skeletal system. Part 2: Metallic spinal screws

---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.
. Spinal implants Components uesd in the surgical fixation of the spinal skeletal system Part 2. Metallic spinal screws ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Partially replaced YY 0119-2002 Spinal implants come within the spine system components Part 2. Metal screws spine system-Part 2. Metalicspinalscrews Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

YY/T 0119 "was within the spinal implant spinal fixation system components" is divided into five sections. --- Part 1. General requirements; --- Part 2. Metal screws spine; --- Part 3. Metal spine board; --- Part 4. Metal spinal rod; --- Part 5. Metal screw spinal static and fatigue bending strength Test method. This section YY/T Section 20119 of. This section drafted in accordance with GB/T 1.1-2009 given rules. Used in this section refer to redraft the law ASTMF2193-07 "standard spinal fixation system components and test methods" in the Annex Record A1 and X2 preparation. This standard and YY 0119-2002 "metal orthopedic implants osteosynthesis with nails", YY 0120-2002 "osteosynthesis implant metal Orthopedic stick, "the main differences. --- YY 0119-2002, YY 0120-2002 in materials including stainless steel, titanium, and the new standard also includes titanium, thus YY/T 0119-2014 broader scope; --- YY/T 0119-2014 has also increased the relative performance testing of metal spine screws, metal plates and metal spine spinal rods. Since the implementation of this section, instead of YY 0119-2002 "metal orthopedic implants osteosynthesis staple" relating to pedicle screws, vertebral Content sacrum nail body and nail. Generic companies can use passive metal surgical implant in accordance with this standard and reference YY 0341-2009 "osteosynthesis Technical conditions "content development of enterprise standards. 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 Medical Device Quality Supervision and Inspection Center, Shanghai Medical Technology Co., Ltd. minimally invasive orthopedics. The main drafters of this section. Zhang Chen, Jiang Xi, said Zhang, Zhang Lu, Wang Guohui, MA Yunpeng. Spinal implants come within the spine system components Part 2. Metal screws spine

1 Scope

This section YY/T 0119 provisions of the spine metal screws classification, materials, requirements and performance. This section applies to internal spinal fixation implants anchoring element.

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 0119.1-2014 come within the spinal implant spinal fixation system components - Part 1. General requirements YY/T 0119.5-2014 spinal fixation system implanted in the spine was part Part 5. Metal screw spinal static and fatigue Bending Strength Test Method Standards ASTMF543 medical metal bone screws and test methods (Specificationandtestmethodsforme- talicmedicalbonescrews) ASTMF1839 orthopedic instruments and tools to test using standard materials - rigid polyurethane foam (Specificationforrigidpolyure- thanefoamforuseasastandardmaterialfortestingorthopedicdevicesandinstruments) Category 3 3.1 In accordance with the classification prescribed ASTMF543 spinal screws classification. 3.2 can also be in accordance with the capacity between the spinal screw fixation system and spinal other components interconnected their classification, such as the expansion head screw Nail, locking screws and self-locking screws.

4 Materials

In accordance with YY/T 0119.1-2014 requirements in Chapter 5 and recommended choice spine screw material. 5 requirements, performance and test methods 5.1 geometric properties Recommended metal spine screw size can be found ASTMF543. 5.2 rotating connection Recommended spine screws in grooves can see ASTMF543 Appendix A6. 5.3 torsional performance Determination of torsional strength properties of the screw in accordance with Test Method ASTMF543 of (yield torque, maximum torque and breaking twist angle). ......

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