YY/T 1465.2-2016Immunogenic evaluation method of medical devices - Part 2: Serum immunoglobulin and complement component detection (enzyme-linked immunosorbent assay) (English PDF)
医疗器械免疫原性评价方法第2部分血清免疫球蛋白和补体成分测定ELISA法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1465.2-2016 is the English-translated version of 医疗器械免疫原性评价方法第2部分血清免疫球蛋白和补体成分测定ELISA法.
YY/T 1465.2-2016 is the Chinese pharmaceutical industry standard that gives the enzyme-linked immunosorbent method for determining the levels of serum immunoglobulins and complement components, used to evaluate the immune response a medical device or material induces.
It is the second part of the YY/T 1465 series and sets out the animals or the sera, the plates and the reagents, the standard curve, the measurement and the way the results are compared with the controls. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1465.2-2016
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative References5
- 3 Terms and Definitions5
- 4 Abbreviation6
- 5 Test Animal6
- 6 Test Principle6
- 7 Test Procedures7
- 8 Test Report9
- Bibliography10
Foreword
YY/T 1465 Immunogenic Evaluation Method of Medical Devices consists of the following parts.
--- Part 1: T Lymphocyte Transformation Test In Vitro;
--- Part 2: Serum Immunoglobulin and Complement Component Detection (ELISA Method). This Part belongs to Part 2 of YY/T 1465.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
1 Scope
This Part gives the method using the enzyme-linked immunosorbent assay to determine the levels of serum immunoglobulin and complement component; it is suitable for the evaluation of immune response products induced by medical devices/materials.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
GB/T 16886.2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements
GB/T 16886.12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 16886.1 and GB/T 16886.20 apply.
4 Abbreviation
The following abbreviations are applicable to this document.
5 Test Animal
5.1 General
All animal tests shall be carried out in the laboratories approved by the national accreditation agency and in compliance with all applicable regulations for laboratory animal welfare; and shall also comply with the requirements of GB/T 16886.2.
5.2 Animal species and requirements
The commonly used experimental animal is a mouse. This Part recommended to use the healthy Grade-SPF, 6-8 weeks of age, half male and half female, BALB/c mice, which have not been tested.
6 Test Principle
Jointly incubate the serum and antibody (primary antibody) coated in a microplate to form an antigen-antibody complex.
7 Test Procedures
7.1 Sample preparation
Prepare the sample according to the principle of GB/T 16886.12. Whenever possible, the medical devices shall be tested in a "standby" state.
7.2 Selection of dose level
7.2.1 Select the dose range referring to the existing immunological research data and information on the toxicokinetic aspects of the test substance and related substance so as to avoid the excessive toxicity. Such information can also help to determine the frequency of dose administration.
7.3 Animal treatment
The in-situ contact method shall be used according to the characteristics of the device and the intended clinical use site. For the devices that are difficult to simulate clinical use and contact, it is advisable to demonstrate the selected contact mode. If using the sample extract to test, it shall establish corresponding extraction medium to treat the control group.
7.5 Test cycle
It is advisable to determine the observation cycle of the test sample according to the results of preliminary test. The test mode of the preliminary test is the same as the major test; generally, take 3 test animals to carry out the preliminary test.
7.7 Detection of serum immunoglobulin
7.7.1 Test method
It is recommended to use the commercially available ELISA kit; detect according to the kit instructions.
7.8 Detection of serum complement component
7.8.1 Test method
It is recommended to use the commercially available ELISA kit; perform the complement component test as per the kit instructions. Other validated test methods can also be used.
8 Test Report
The test report shall contain the following information. […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.2Biological evaluation of medical devices - Part 2: Animal welfare requirements
- GB/T 16886.12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.12-2023 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB/T 16886.2-2011 — Biological evaluation of medical devices -- Part 2: Animal welfare requirements
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