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YY/T 1429-2016: Implants for surgery. Acrylic resin cement. Flexural fatigue testing of acrylic resin cements used in orthopaedics
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1429-2016 | English | 154 |
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Implants for surgery. Acrylic resin cement. Flexural fatigue testing of acrylic resin cements used in orthopaedics
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YY/T 1429-2016
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Basic data | Standard ID | YY/T 1429-2016 (YY/T1429-2016) | | Description (Translated English) | Implants for surgery. Acrylic resin cement. Flexural fatigue testing of acrylic resin cements used in orthopaedics | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 8,892 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | YY 0459-2003; ISO 16428 | | Adopted Standard | ISO 16402-2008, IDT | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to polymethacrylic acid based resin bone cement, and detailed description of the polymerization of bone cement fatigue characteristics of the test steps. This standard does not cover the hazards of patients or bone cement users when using bone cement. | YY/T 1429-2016: Implants for surgery. Acrylic resin cement. Flexural fatigue testing of acrylic resin cements used in orthopaedics
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Implants for surgery.Acrylic resin cement.Flexura fatigue testing of acrylic resin cements used in orthopaedics
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Surgical Implants Acrylic Resin Bone Cement
Acrylic resin for orthopedic surgery
Test Method for Bending Fatigue Performance of Bone Cement
(ISO 16402..2008, IDT)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
1 Scope 1
2 normative reference document 1
3 Overview of test methods 1
Equipment and equipment
5 sample selection and preparation 2
6 Test Step 3
7 Test Report 5
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the translation method equivalent to ISO 16402..2008 "Surgical Implants Acrylic Resin Bone Cement Orthopedic Surgery C
Standard Test Method for Bending Fatigue Performance of Acrylic Resin Bone Cement ". For ease of use, this standard has been modified as follows.
--- in accordance with the Chinese language used to modify some of the format;
--- to some of the statements applied to international standards to apply to the formulation of our standards;
--- will be Chapter 2 "normative reference document" has been converted into national standards instead of using national standards.
And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows.
YY/T 1427-2016 Test solutions and conditions for surgical and medical devices for static and dynamic corrosion testing of surgical implants
(ISO 16428..2007, IDT)
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 drafting unit of this standard. State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, the State Food and Drug Administration
General Administration of Medical Devices Technical Review Center.
The main drafters of this standard. Zhang Lu, Gao Jintao, Ma Chunbao, Liu Yinghui, Zhang Jiazhen.
Surgical Implants Acrylic Resin Bone Cement
Acrylic resin for orthopedic surgery
Test Method for Bending Fatigue Performance of Bone Cement
1 Scope
This standard applies to polymethacrylate-based resinous bone cement, and detailed description of the polymerization of bone cement fatigue properties
Of the test steps.
This standard does not cover the hazards of patients or bone cement users when using bone cement.
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.
YY 0459-2003 Surgical Implants Acrylic Resin Bone Cement (ISO 5833..2002, IDT)
ISO 16428 Surgical implants - Determination of open-circuit potentials for the evaluation of corrosion characteristics of metal implants and medical equipment after extension
Method (Implantsforsurgery-Testsolutionsandenvironmentalconditionsforstaticanddynamiccorro-
siontestsonimplantablematerialsandmedicaldevices)
3 Overview of test methods
The test uses rectangular strip samples. See Chapter 5 for the preparation of the sample.
The bending strength of the specimen is obtained by a four-point bending test under quasi-static or periodic load conditions. Under the conditions of the cycle load introduced two
Method. The first method follows the Wöhler theory (S/N curve method), which determines the bending properties in the case of full stress. Second
Method (low stress method) Determines the bending characteristics only at lower stress conditions. In clinical applications it is possible to encounter these specific low stresses
Happening.
4 equipment
4.1 Equipment for mixing bone cement, recommended by bone cement manufacturer.
4.2 mold, with the appropriate material made of mold, the sample processing growth 75mm, 10mm wide and 3.3mm high rectangular test strip. and also
The mold can be made into a 3.3 mm sheet with a thickness of 3.3 mm and cut into the size of the test strip. All molds in contact with bone cement
With a surface application of 400 mesh sandpaper for grinding.
Note. There can be a certain degree of stiffness of the metal materials, such as aluminum or stainless steel.
4.3 Smooth plate, prepared from a suitable material (two for each mold), shall be sufficient to cover the upper and lower surfaces of the mold as described in Section 4.2.
4.4 release agent, easy to sample and mold separation.
Note. can be used PTFE spray, vacuum grease or beeswax and so on.
4.5 polyester film, covering the mold plate.
4.6 C-clamp or other device that can clamp the mold between the upper and lower plates.
4.7 bending test equipment, can be applied to reach.200N load, can be applied between the 0N to set the value of the linear or sinusoidal cycle of the load
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