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YY/T 1506-2016: Implants for surgery--Test method for driving torque of metallic bone screws
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1506-2016 | English | 119 |
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Implants for surgery--Test method for driving torque of metallic bone screws
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YY/T 1506-2016
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Basic data | Standard ID | YY/T 1506-2016 (YY/T1506-2016) | | Description (Translated English) | Implants for surgery--Test method for driving torque of metallic bone screws | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Word Count Estimation | 6,653 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | JJG 269 | | Adopted Standard | ASTM F 543-2013, NEQ | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard is applicable to measuring the torque required for screwing out the standard material by screwing the metal screw (hereinafter referred to as "screw"). The results obtained using this standard are not directly related to the rotational torque required for the screw to be inserted into the human bone. The purpose of this standard is to confirm the consistency of the tested product. | YY/T 1506-2016: Implants for surgery--Test method for driving torque of metallic bone 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.
Implants for surgery - Test method for driving force of metallic bone screws
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical Implants Metal Bone Screws
Rotational torque test method
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
The use of re-drafting of this standard refers to ASTM F543-2013 Appendix A2 "Medical metal screw screw rotation test method"
prepared by.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Surgical Implantation and Orthopedic Equipment Standardization Technical Committee Orthopedic Implants Sub-Technical Committee (SAC/TC110 /
SC1).
The standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, a medical device China (limited) company.
The main drafters of this standard. Zhang, Li Wenjiao, Wang Zuoxiao, Chen Changsheng, Wang Jian.
Surgical Implants Metal Bone Screws
Rotational torque test method
1 Scope
This standard is used to measure the torque required for the metal screw (hereinafter referred to as "screw") to be screwed into the standard material. Use this standard
The result is not directly related to the rotational torque required for the screw to be inserted into the human bone. The purpose of this standard is to confirm only one of the tested products
To cause.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
JJG269 Torsion Testing Machine Verification Regulation
3 equipment
3.1 Test device
The device shown in Fig. 1 can be applied to a screw-in torque test. The test device shall be capable of testing with ASTM F1839 material
Block, test block fixture, drill sleeve and description of the drill sleeve clamp tooling fit. The test device should have sufficient stiffness to allow the test to be loaded
No deflection or deformation occurs.
Figure 1 Rotational torque test device
3.2 Torque sensor
The converter that converts the applied torque into a continuously recordable electrical signal is calibrated within the range of the range used in the test.
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