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US$174.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. 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 0662-2008 | English | 174 |
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Implants for surgery. Metal bone screws with asymmetrical thread and spherical under-surface. Mechanical requirements and test methods
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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 ---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.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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