YY/T 0856-2011 English PDF

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YY/T 0856-2011: Implants for orthosynthesis. Metallic angled fixation device
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0856-2011	529	Add to Cart	4 days	Implants for orthosynthesis. Metallic angled fixation device	Valid

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Basic data

Standard ID: YY/T 0856-2011 (YY/T0856-2011)
Description (Translated English): Implants for orthosynthesis. Metallic angled fixation device
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 23,219
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Older Standard (superseded by this standard): YY 0017-2008
Quoted Standard: GB/T 228; GB 4234; GB/T 10623; GB/T 12417.1; GB 23102; GB/T 24629; JJG 139; YY/T 0342; YY 0605.9; YY/T 0640-2008; ISO 5832-3; ISO 5835; ISO 5836; ISO 9268; ISO 9269; ASTM E122; ASTM F382; ISO 5832-2
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 applies to orthopedic fixation using metal angle holder (hereinafter referred to as the angle holder). This standard established a right angle fixator and functional properties of geometric characteristics to classify and define a consistent approach. This standard also angle fixator materials, manufacturing, sterilization, packaging, marking, labeling and instructions for use given standard, right angle fixation in the body associated with the use of the important mechanical properties also gives the standard test methods. This standard does not purport to specified angle holder for a specific level of performance of clinical manifestations, the absence of adequate knowledge, yet can not be predicted in individual patients daily special events use the results. In addition, the standard does not provide for the fixation point of the skeletal system specially designed holder. This standard may not apply to all types of angles holder. Recommendations from the specific perspective of the fixed point and its potential uses carefully consider the suitability of this standard. This standard includes the following angle fixator used to test the mechanical properties of test methods: metal bending angle fixator single test method (see Appendix A), metallic angle fixator bending fatigue performance test method (see Appendix B). Unless a separate statement, the criterion used by the International System of Units (SI).

YY/T 0856-2011: Implants for orthosynthesis. Metallic angled fixation device

---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 orthosynthesis.Metallic angled fixation device ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Partially replaced YY 0017-2008 Osteosynthesis implant metal angle holder Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Category 5 5 material 5 6 5 General requirements and performance Manufacturing 7 5 Sterilization 8 5 9 Package 5 10 information supplied by the manufacturer 5 Appendix A (normative) metal bending angle holder Single Test Method 7 Fatigue performance test method in Appendix B (normative) metal bending angle holder 12 Annex C (informative) Fundamentals 17 Annex D (informative) Appendix A basic principle 18 Annex E (informative) Appendix B of the 19 basic principles

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Since the implementation of this standard, YY 0017-2008 relevant metal angle holder annulment, businesses can according to the criteria and parameters Examination YY 0341 development of enterprise standards. "Requirements and test methods for metallic angle fixator" used in this standard reference method redrafted ASTMF384-06 establishment. This standard compared with ASTMF384-06, the main differences are as follows. --- On normative references, this standard 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 the GB/T 12417.1 instead of ISO 14602; ● with the GB/T 228 instead ASTME8; ● with the GB/T 24629 instead ASTMF565; ● with the GB/T 10623 instead ASTME1823; ● with JJG139 instead ASTME4. ● Remove the ASTMF67, ASTMF75, ASTMF90, ASTMF136, ASTMF138, ASTMF139, ASTMF620, ASTMF621, ASTMF1295, ASTMF1314, ASTMF1472, ASTMF1713, ASTME4, ASTME467. ● Combination of conditions added to GB 4234, GB 23102, YY 0605.9, ISO 5832-2, ISO 5832-3. --- Delete the contents of the old version ASTMF384. --- Deleted the Chapter 7, "keywords." --- In Appendix X1 to Appendix A, and Appendix X2 to Appendix B, and Appendix X3 to Appendix C, Appendix X4 will to Appendix D, will Appendix X5 to Appendix E, remains unchanged. --- Increased Chapter 7, "manufacturing", Chapter 8, "sterilization," Chapter 9, "packaging", Chapter 11, "information provided by the manufacturer," and Chapter 5 to Chapter 11 of the content and order have been adjusted. 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 standard was proposed by the State Food and Drug Administration. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee (SAC / TC110/SC1) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Northwestern Polytechnical University. The main drafters. Zhang said, Zhang Lu, Dong Shuangpeng, Jiaoyong Zhe Song Duo, Fu Zengxiang. Osteosynthesis implant metal angle holder

1 Scope

This standard is intended for the orthopedic implant surgery using metal angle holder (hereinafter referred to as the angle of the holder) provides a comprehensive reference. Geometric characteristics and features of this standard to establish a fixed angle on the classification and definition of a consistent approach. This standard also fixed angle The materials, manufacturing, sterilization, packaging, marking, labeling and instructions for use given standard, for fixed angle in the body associated with its use Important mechanical properties are also given a standard test methods. This standard is not intended to be a predetermined angle holder for a specific clinical manifestations of performance levels, due to insufficient knowledge, not yet Forecast uses the results of its special events in the daily life of the individual patient. Furthermore, the standard does not provide for internal bone fixation system Specially designed angle fixator. This standard may not apply to all types of angles holder. From the perspective of specific recommendations to fix the angle and its potential use caution Consider the applicability of this standard. Note 1. This standard does not apply to the intramedullary hip screws and other non-plate angle holder. This standard covers the following test methods to test the mechanical properties of the angle of the holder to. --- Metal bending angle holder single test method (see Appendix A); --- Metal holder angle bending fatigue performance test methods (see Appendix B). Unless a separate statement, this standard adopts the International System of Units (SI). Note 2. There is no equivalent international standards or equivalent.

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. GB/T 228 metal materials at room temperature tensile test method GB 4234 stainless steel surgical implants GB/T 10623 test the mechanical properties of metallic materials term GB/T 12417.1 active surgical implants bone and joint replacement implants - Part 1. Particular requirements for osteosynthesis implants GB 23102 surgical implant metal material alloy Ti-6Al-7Nb processing materials GB/T 24629 Surgical implants orthopedic implants maintenance and operation JJG139 tension, pressure, and universal testing machine Determination of the strength and stiffness of YY/T 0342 surgical implant plate bending Part 9 YY 0605.9 surgical implant metal material. Forged high nitrogen stainless steel YY/T 0640-2008 active surgical implants General requirements ISO 5832-2 Implants for surgery metallic materials - Part 2. Titanium (Implantsforsurgery-Metalicmaterials- Part 2. Unaloyedtitanium) ISO 5832-3 Implants for surgery - Metallic materials - Part 3. Forged -6Al-4V titanium alloy (Implantsforsurgery- Metalicmaterials-Part 3. Wroughttitanium6-aluminium4-vanadiumaloy) ISO 5835 surgical implant hexagonal drive connection, spherical under surface, asymmetrical thread metal bone screw size (Implants forsurgery-Metalicbonescrewswithhexagonaldriveconnection, sphericalunder-surfaceofhead, ......

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