YY/T 1465.2-2016 English PDF (YYT1465.2-2016)

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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 immunoadsorbent assay)
YY/T 1465.2-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
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.
Immunogenic Evaluation Method of Medical Devices -
Part 2. Serum Immunoglobulin and Complement
Component Detection
(Enzyme-Linked Immunosorbent Assay)
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
GB/T 16886.20 Biological Evaluation of Medical Devices - Part 20. Principles and
Methods for Immunotoxicology Testing of Medical Devices
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.
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.
7.2.2 It is advisable to select the test dose and frequency of immunization according
to the intended use of the product and the dose to be clinically used by the human
body; meanwhile consider the tolerance of the test animals; the test substance shall
be tested in a multi-dose group. It is recommended to use at least three dose
concentrations like high, medium and low concentration; one negative control group
and one positive control group. When setting the dose group, it shall consider the dose
that is used clinically by the human body.
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
a) Positive control group. BSA is recommended to be a positive control substance.
Take 3mg of BSA to mix up with 9mL of PBS (pH 7.4); then mix with CFA in a
volume ratio of 1.1 to form an emulsion; each animal was subcutaneously
injected with 0.12mL on the back; inject once every week. A total of 4
immunizations. 10 animals/group.
b) Test sample group. Take the test sample; give the test animals in a suitable
manner; 10 animals/dose group.
c) Negative control group. Except that the test substance was not used for treatment;
the same operation and treatment method as the test animals in the test group
shall be carried out; 10 animals/group.