YY/T 1465.2-2016 PDF English
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Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)
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YY/T 1465.2-2016: Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1465.2-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.01
C 30
Immunogenic Evaluation Method of Medical Devices -
Part 2.Serum Immunoglobulin and Complement
Component Detection
(Enzyme-Linked Immunosorbent Assay)
Issued on. JANUARY 26, 2016
Implemented on. JANUARY 01, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 5
4 Abbreviation... 6
5 Test Animal... 6
6 Test Principle... 6
7 Test Procedures... 7
8 Test Report... 9
Bibliography... 10
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.
Please note that some contents of this document may involve patents. The issuing
organization of this document shall not assume the responsibility for identifying these
patents.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee for
Standardization of Biological Evaluation on Medical Devices (SAC/TC 248).
Drafting organizations of this Part. Jinan Quality Supervision and Inspection Center for
Medical Devices of China Food and Drug Administration; Institute for Medical Devices
Control of National Institutes for Food and Drug Control; and Sichuan Testing Center
for Biomaterials and Medical Devices.
Chief drafting staffs of this Part. Gai Xiaoxiao, Yin Yuxia, Wang Xin, Chen Liang, Xu
Jianxia, Yuan Tun, and Liang Jie.
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.
7.4 Test grouping
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.
7.6 Preparation of serum
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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