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YY/T 1823-2022: Cardiovascular implants - Standard test method for nickel ion release of nickel-titanium alloy
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Cardiovascular implants - Standard test method for nickel ion release of nickel-titanium alloy
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YY/T 1823-2022
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Basic data | Standard ID | YY/T 1823-2022 (YY/T1823-2022) | | Description (Translated English) | Cardiovascular implants - Standard test method for nickel ion release of nickel-titanium alloy | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Word Count Estimation | 19,168 | | Issuing agency(ies) | State Drug Administration | YY/T 1823-2022: Cardiovascular implants - Standard test method for nickel ion release of nickel-titanium alloy
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Cardiovascular implants - Standard test method for nickel ion release of nickel-titanium alloy
ICS 11.040.40
CCSC35
People's Republic of China Pharmaceutical Industry Standard
Cardiovascular Implants
Nitinol alloy nickel ion release test method
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Test method 2
5 Result calculation 4
6 Report 5
Appendix A (Informative) In Vitro Determination of Nickel Ion AL6
Reference 11
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices Subcommittee on Cardiovascular Implants (SAC/
TC110/SC2) focal point.
This document is drafted by. Lifetech Technology (Shenzhen) Co., Ltd., Shenzhen Leading Medical Service Co., Ltd., Shenzhen Medical Device Testing
Center, Jiangyin Farsenpeier New Material Technology Co., Ltd., National Standard (Beijing) Inspection and Certification Co., Ltd., Tianjin Medical Device Quality Supervision
inspection center.
The main drafters of this document. Liu Yanwen, Muying, Li Anning, Yang Han, Peng Jun, Wang Lingling, Chen Qingfu, Zhang Wenmei, Fan Zhigang, Ma Jinzhu,
Duan Qingjiao.
Introduction
Nickel ion is a heavy metal ion. Excessive intake of nickel can cause central circulation and respiratory disorders, and cause water in the heart muscle, brain, lung and kidney.
Swelling, bleeding or degeneration may increase the incidence of leukemia and cancer. Studies have shown that nickel has immunotoxicity, especially for those allergic to nickel.
crowd. In the adult population, nickel allergy is estimated to occur in 10% of women (17%) higher than men (3%) [22].
Therefore, after Nitinol cardiovascular implants are implanted in the human body, the release rate and release amount of Ni ions from Nitinol alloys are used to evaluate their clinical use.
Important content for security. However, due to the long time, high cost, and low accuracy of the test results in vivo (the body's interference with the test results)
In the preclinical evaluation stage, it is advisable to establish an in vitro nickel ion release model to form an in vitro test for nickel ion release evaluation.
method.
At present, there is no similar test standard for in vitro release of nickel ions in China. The formulation of this document will fill this gap and establish
Unified test method for nickel ion release in vitro from nitinol cardiovascular implants. If the pitting test results do not meet the expected defined acceptance criteria
If the surface finishing process of the device does not have a good history of clinical use [8], it is recommended to use this document to evaluate the nickel ion content through the in vitro test.
The risk of nickel ion release can be estimated to better ensure the safety of related products in clinical use.
Cardiovascular Implants
Nitinol alloy nickel ion release test method
1 Scope
This document specifies a test method for the in vitro release of nickel ions from nickel-titanium alloy cardiovascular implants.
An example of the calculation of the maximum allowable limit.
This document applies to nickel-titanium alloy cardiovascular implants, including vascular stents, cardiac occluders, vena cava filters, heart valves, etc.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB/T 16886.1-2011 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process
GB/T 16886.17-2005 Biological Evaluation of Medical Devices Part 17.Establishment of Allowable Limits for Leachables
Chinese Pharmacopoeia (four volumes of the 2020 edition)
3 Terms and Definitions
The terms and definitions defined in GB/T 16886.17-2005 and the following apply to this document.
3.1
detectionlimit detectionlimit
Under the optimal test conditions, measure no less than 7 blank sample solutions to continuously measure 3 times the standard of the response value of the blank sample solution
The concentration of the element to be measured corresponding to the deviation (3SD).
3.2
quantitativelimit
Under the best test conditions, measure no less than 7 blank sample solutions to continuously measure 10 times the standard deviation of the response value of the blank solution.
The concentration of the element to be tested corresponding to the difference (10SD).
3.3
simulated-use extraction simulated-use extraction
The test material or sample is extracted with a suitable medium under conditions simulating the use of the product, the purpose of which is to evaluate the
Potential hazards to the patient or user during bed use.
Note. The simulated use of leaching should consider all possible conditions such as the tissue contacted by the device, contact temperature and contact time, and assume the most severe conditions of use.
3.4
Sample test area testareaofsample
The surface area of the Nitinol portion of the device that comes into contact with the human body.
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