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YY/T 0662-2008 English PDF

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YY/T 0662-2008: Implants for surgery. Metal bone screws with asymmetrical thread and spherical under-surface. Mechanical requirements and test methods
Status: Valid
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YY/T 0662-2008English174 Add to Cart 3 days [Need to translate] Implants for surgery. Metal bone screws with asymmetrical thread and spherical under-surface. Mechanical requirements and test methods Valid YY/T 0662-2008

PDF similar to YY/T 0662-2008


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Basic data

Standard ID YY/T 0662-2008 (YY/T0662-2008)
Description (Translated English) Implants for surgery. Metal bone screws with asymmetrical thread and spherical under-surface. Mechanical requirements and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 9,950
Date of Issue 2008-04-25
Date of Implementation 2009-06-01
Quoted Standard ISO 5832-1; ISO 5835
Adopted Standard ISO 6475-1989, IDT
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies test surgical metal bone fracture screw breakage torque and torsion angle of test methods. The mechanical properties of bone screws are specified in Annex A.

YY/T 0662-2008: Implants for surgery. Metal bone screws with asymmetrical thread and spherical under-surface. Mechanical requirements and test methods


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Implants for surgery.Metal bone screws with asymmetrical thread and spherical under-surface.Mechanical requirements and test methods ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards YY/T 0662-2008/ISO 6475. 1989 Surgical implants asymmetrical thread and spherical Mechanical properties of bone screws metal surface Requirements and test methods (ISO 6475. 1989, IDT) Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

Foreword

This standard is identical with ISO 6475. 1989 "surgical implants asymmetrical thread and spherical under surface of the metal bone screw machinery And test methods "performance requirements. Appendix A of this standard is a normative appendix, Appendix B and Appendix C are informative appendices. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) and focal points. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Wang Zuo Xiao Song Duo, Zhang Chen, Sun Huili, Li Nan. YY/T 0662-2008/ISO 6475. 1989 Surgical implants asymmetrical thread and spherical Mechanical properties of bone screws metal surface Requirements and test methods

1 Scope

This standard specifies the test method for testing a surgical screw breakage torque and torsion angle fracture with metal bone. Bone screw machine Performance requirements in Appendix A. Note 1. The current data only applies to stainless steel in accordance with ISO 5832-1 and ISO 5835 compliance with the provisions of the size of the bone screw. When access to other material When the material and/or other standards consistent with the size of bone screws data, which will be added to a new appendix. Note 2. The relationship between the relevant plates, bone screws and relevant international standards between the tools, see Appendix B.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. ISO 5832-1 Implants for surgery - Metallic materials - Part 1. Forged steel ISO 5835 surgical implant hexagonal drive connection, spherical under surface, asymmetrical thread metal bone screw size Test Method 3 3.1 device Test equipment should be used with the following characteristics. a) the maximum sensitivity on the lowest range of not less than 0.01N · m or equivalent, full-scale reading on other range maximum flexibility Acuity less than 1%; Select b) range (see 3.2.4); c) can be recorded when the test reaches maximum torque; d) preventing screw element off from means for applying torque. Note. The test equipment must meet the requirements specified in the national testing body. 3.2 Program 3.2.1 The bone screw inserted into the jaw and locking device, so that should meet the following conditions. a) when possible, thread the tail should have five complete threads exposed; Note. From the tail of the thread holding position, counting direction of the screw head, there are five complete threads exposed. b) clamping parts not loose; c) screw axis coincident with the axis element should be applied torque. 3.2.2 Select a constant angular velocity in 1r/min ~ 5r/min within the range of the torque applied to the screw head in a row until the occurrence of a screw fracture. 3.2.3 record the maximum torque fracture and fracture torsion angle. 3.2.4 If the record of the maximum fracture torque is less than 20% of full scale reading test, the results should be ignored, and heavy on the lower one range Repeat the above test. Note. The use of electronic torsion testing machine, within the range of measurement precision, the results should be valid. YY/T 0662-2008/ISO 6475. 1989

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