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YY/T 1427-2016: Implants for surgery. Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
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Implants for surgery. Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
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YY/T 1427-2016
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Basic data | Standard ID | YY/T 1427-2016 (YY/T1427-2016) | | Description (Translated English) | Implants for surgery. Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 11,129 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | ISO 3696; YY/T 0695-2008 | | Adopted Standard | ISO 16428-2005, IDT | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the standard environmental conditions for the testing of implants for metal materials, surgical implants and medical devices. This test condition simulates the physiological conditions by controlling the simplified solution of the test solution, temperature, ventilated environment, sample size to the volume of the solution. Where necessary, the application of these environmental test conditions can be combined with various static or dynamic tests that are affected by physiological conditions. Typical applications include corrosion fatigue tests, fretting and wear tests, conventional electrochemical tests. This standard does not take into account typical joint simulator tests and specific applications in the dental field. Attempts to reproduce the tribological properties of body fluids, such as solutions for abrasion studies, are outside the scope of this standard. | YY/T 1427-2016: Implants for surgery. Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
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Implants for surgery.Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
ICS 11.040.40
C30
People's Republic of China Pharmaceutical Industry Standard
Surgical implants for implantable materials and
Medical devices are static and
Test solutions and conditions for dynamic corrosion testing
(ISO 16428..2005, IDT)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 meaning and application 2
5 Environmental test conditions 2
6 Sample 3
7 Evaluation and Reporting 3
Appendix A (informative) Other recommended test solutions 5
Appendix B (informative) considerations for surface preparation and test evaluation 6
Reference 7
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 16428..2005 "Surgical implants Implantable materials and medical devices Static and dynamic rot
Test solution and conditions for corrosion test ". 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;
- In view of the specific definition of "static and dynamic test" in section 3.5 of the original text and the following paragraphs,
3.5 terms.
And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows.
Analysis of laboratory water specifications and test methods (ISO 3696. 1987, MOD) GB/T 6682-2008.
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. Jiang Xi, Zhang Zhenghui, Ma Jinzhu, Qi Baofen, Zhang Jiazhen, Min Yue.
Introduction
In many cases, medical devices and materials are tested in a physiological environment, for research, development work, and surgical implants and devices
Performance evaluation is very desirable. It is often difficult to apply a physiological stock solution because the medium is rapidly deteriorating.
Application of artificial media is common, but the shortcomings of the composition of the larger differences, the test results are usually not comparable.
This standard specifies the use of isotonic sodium chloride (NaCl) solution as a reproducible basic environmental condition. Because this solution is used for surgery
The injection and rinse during surgery contain an ion content similar to that of human body fluids, so the solution is suitable. More importantly, the vast majority
The corrosion resistance of metals is very sensitive to chloride ions (Cl-). Therefore, isotonic sodium chloride solution has been widely used in testing medical care
instrument.
Surgical implants for implantable materials and
Medical devices are static and
Test solutions and conditions for dynamic corrosion testing
1 Scope
This standard specifies the standard environmental conditions for the testing of implants for metal materials, surgical implants and medical devices. This test condition is controlled
The temperature of the test solution, the temperature, the ventilating environment, the ratio of the sample size to the volume of the solution, and the like to simulate the physiological conditions.
Where necessary, the application of these environmental test conditions can be combined with various static or dynamic tests that are affected by physiological conditions. typical
Application of corrosion fatigue test, micro-wear and wear test, conventional electrochemical test.
This standard does not take into account typical joint simulator tests and specific applications in the dental field. Trying to reproduce the body fluid tribological properties of the solution,
Such as solutions for abrasion studies, are outside the scope of this standard.
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.
ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification
andtestmethods)
Standard Test Method for Cyclic Potentiostatic Polarization of Corrosive Sensitivity for Small Implant Instruments YY/T 0695-2008
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Corrosion fatigue test
In the human physiological environment similar to the test solution in a cyclic loading test to evaluate the corrosion fatigue performance.
NOTE. The test solution may cause viscous corrosion effects and/or accelerated fatigue processes.
3.2
Test conditions
Sample (sample) test conditions, including test solution, temperature, aeration, pH, volume ratio and liquid exchange.
3.3
Isotonic sodium chloride solution isotonicsodium chloride
Sodium chloride aqueous solution (0.9% sodium chloride mass fraction) provides the same osmotic pressure as the physiological fluid (serum) in living tissue.
Note. Applications such as surgery can prevent tissue damage.
3.4
Ringer's solution Ringer'ssolution
An isotonic solution containing sodium chloride and an additional compound which is consistent with a part of the body fluid (serum) of the human body.
Note. See Appendix A.
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