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YY/T 1074-2002

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标准编号: YY/T 1074-2002 (YY/T1074-2002)
中文名称: 外科植入物 不锈钢产品点蚀电位
英文名称: Implants for surgery - Measuring method for pitting corrosion potential on stainless products
行业: 医药行业标准 (推荐)
中标分类: C30
国际标准分类: 11.040.40
字数估计: 8,841
发布日期: 2002-09-24
实施日期: 2003-04-01
旧标准 (被替代): YY 91074-1999
起草单位: 北京科技大学、国家药品监督管理局天津医疗器械质量监督检验中心
归口单位: 全国外科植入物和矫形器械标准化技术委员会(CSBTS/TC110)
提出机构: 国家药品监督管理局
发布机构: 国家药品监督管理局


YY/T 1074-2002
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 30
Replacing YY 91074-1999
Implants for surgery - Measuring method for pitting
corrosion potential on stainless products
外科植入物 不锈钢产品点蚀电位
Issued by. China Food and Drug Administration
ISSUED ON. SEPTEMBER 24, 2002
IMPLEMENTED ON. APRIL 1, 2003
Table of Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative References ... 4 
3  Terms ... 4 
4  Test instruments and equipment ... 5 
5  Preparation of sample ... 5 
6  Test conditions and steps ... 6 
7  Test results ... 7 
8  Test report ... 7 
Appendix A ... 8 
Appendix B ... 9 
Foreword
This standard adopts the test solution and test temperature provisions of the simulated
human physiological environment that are specified in No. 405, 406 “New Working Item”
proposed by the International Organization for Standardization (ISO) Technical Committee
150 on October 24, 1997. For the test instruments and equipment, sample preparation,
and test steps, reference is made to some provisions in GB/T 17899-1999 “Method of
Pitting Potential Measurement for Stainless Steels”.
Appendix A and B of this standard are normative.
YY 91074-1999 (ZB C35 005-1985) “Corrosion Test Methods for Metallic Bone Plates and
Bone Screws” shall be abolished, since the issuing date of this standard.
This standard was proposed and approved by China Food and Drug Administration.
This standard shall be under the jurisdiction of the National Technical Committee on
Implants for Surgery and Orthopedic Devices of Standardization Administration of China
(CSBTS/ TC110).
Main drafting organizations of this standard. University of Science & Technology Beijing,
and Tianjin Medical Device Quality Supervision and Testing Center of China Food and
Drug Administration.
Main drafters of this standard. ZHANG Lin, QI Baofen, REN Fengmei, and DING Baofeng.
Implants for Surgery - Measuring Method for Pitting
Corrosion Potential on stainless products
1 Scope
This standard specifies the definitions of measuring method for pitting corrosion potential
on stainless surgical products; and the requirements of the measuring system’s test
instruments and equipment, sample preparation, test conditions and steps, test result, and
test report.
This standard is applicable to the measurement that adopts potentiodynamic method to
measure the pitting corrosion potential of stainless surgical implant products in the
simulated human physiological environment.
2 Normative References
The articles contained in the following documents have become part of this standard when
they are quoted herein. For the dated documents so quoted, all the modifications
(excluding corrections) or revisions made thereafter shall not be applicable to this
standard. For the undated documents so quoted, the latest editions shall be applicable to
this standard.
GB/T 1266-1986 Chemical reagents - Sodium chloride
3 Terms
For the purpose of this standard, the following terms and definitions shall apply.
3.1
Pitting corrosion
Pit-shaped corrosion that extends from the surface to the internal part of metal which may
be developed into cavity.
3.2
Free corrosion potential (Ek)
It refers to the electrode potential of the designated electrolyte solution when no net
current flows into or out of the research metal surface.
5.3 Selection of test surface. For plate products, select rolling surface. For rod or wire
products, select drawing surface. The test surface shall be away from edge, sharp corner,
hole, groove, thread, mark, and welding spot. If there is no flat surface, select smooth
spherical surface or cylinder surface.
5.4 Coating of sample. The surface of sample shall be wiped and cleaned by alcohol and
acetone. After drying process, use insulating sealant (704 silicone rubber, epoxy resin and
vinyl resin) to coat or inset the sample, so as to make the final exposed test surface to be
about 1 cm2. If the sample is too small, the test surface can be less than 1 cm2. No crevice
or pit is allowed on the insulated coating surface.
6.1 Test conditions
6.1.1 Test solution. 9 g/L sodium oxide.
Dissolve 9 g of analytically pure sodium chloride that conforms to provisions of GB/T 1266
into 1 000 ml of distilled water or deionized water.
6.1.2 Test temperature. 37°C±1°C.
6.2 Test steps
6.2.1 Inject appropriate test solution into a clean electrolytic tank; then place the
electrolytic tank into thermostatic water bath (temperature controlled at 37°C±1°C).
6.2.2 Install the working electrode (sample), saturated calomel electrode, and platinum
electrochemical measurement system diagram (Appendix B), and then fix them.
6.2.3 Fully submerge the working electrode (sample), reference electrode, and auxiliary
electrode into test solution. The upper edge of insulating part shall be at least 1cm higher
than the test solution. The top end of luggin capillary of reference electrode shall be 1 to 2
mm away from the test surface of working electrode.
6.2.4 Connect the wire according to operation instructions. Put the switch and button at
the required positions. Input the relevant parameters (select constant potential control,
and record E-logi anode polarization curve).
6.2.5 After 10min, record the free corrosion potential. Start from the free corrosion
adjust the potential, so as to make sample to be anodic polarization. When the anodic
current density reaches 500μA/cm2~1 000μA/cm2, end the test.
Appendix A
(Normative)
Supplementary explanation
A.1 This standard is also applicable to the measurement by adopting manual step-method.
The potential variation speed is to keep constant potential for 1 min per 20 mV, or for 2
min per 40mV. List out the potential and current values; draw the E-logi anode polarization
curve.
has crevice corrosion or coating is properly sealed. If there is crevice corrosion, the
corrosion potential value at this point shall be omitted and void; and test shall be
re-conducted.
A.3 The pitting corrosion potential measured by this standard only indicates the
anti-corrosion level of the surface of the product, and represent the quality of the product
and the processing level of surface treatment; it does not replace the random defect test
of the product surface.
   
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