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YY/T 1465.4-2017 English PDF (YYT1465.4-2017)

YY/T 1465.4-2017 English PDF (YYT1465.4-2017)

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YY/T 1465.4-2017: Immunogenic evaluation method of medical devices?€?Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes?€?Ex-vivo method

This Part of YY/T 1465 gives the ex-vivo method for the determination of phagocytosis of mouse peritoneal macrophages on chicken erythrocytes. This Part applies to the evaluation of the influence of medical devices/materials on phagocytic ability of macrophages.
YY/T 1465.4-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.01
C 30
Immunogenic evaluation method of medical devices - Part
4. Phagocytosis of mouse peritoneal macrophages on
chicken erythrocytes - Ex-vivo method
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 2018
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 Test principles ... 6
5 Test animal ... 6
6 Sample preparation and route of exposure ... 6
7 Selection of control sample ... 7
8 Test procedures ... 7
9 Result calculation ... 9
10 Result judgement ... 9
11 Reliability inspection ... 9
12 Test report ... 10
References ... 11
Immunogenic evaluation method of medical devices - Part
4. Phagocytosis of mouse peritoneal macrophages on
chicken erythrocytes - Ex-vivo method
1 Scope
This Part of YY/T 1465 gives the ex-vivo method for the determination of phagocytosis of mouse peritoneal macrophages on chicken erythrocytes.
This Part applies to the evaluation of the influence of medical devices/materials on phagocytic ability of macrophages.
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the versions with the dates indicated are applicable to this document. For the undated references, 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 within a risk management process (GB/T 16886.1-2011, ISO
10993-1.2009, IDT)
GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal
welfare requirements (GB/T 16886.2-2011, ISO 10993-2.2006, IDT)
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity (GB/T 16886.11-2011, ISO 10993-6.2006, IDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (GB/T 16886.12-2005, ISO 10993-
12.2002, IDT)
GB/T 16886.20 Biological evaluation of medical devices - Part 20. Principles and methods for immunotoxicology testing of medical devices (GB/T
16886.20-2015, ISO/TS 10993-20.2006, IDT)
3 Terms and definitions
with reference to the requirements of acute, subacute, subchronic, and chronic systemic toxicity tests in GB/T 16886.11, and shall be stated in the final test report.
6.2 For degradable medical devices, it shall, according to intended clinical application mode, design the device-animal contact/immune mode. When there is available research literature, the method reported in the existing literature can be used for test design, to compare with the existing data. When there is no animal contact/immune mode which can be referenced, an implantation route similar to the intended clinical application mode may be considered.
6.3 The liquid test substance can be used directly or diluted.
Note. The immunogens in medical devices are mostly macromolecular substances. If sample extracts are prepared, the effectiveness of the selective extraction method shall be explained.
7 Selection of control sample
7.1 Positive control
Recommended positive control substances which can promote phagocytic
ability of macrophages include. 100 IU/g ?? interferon (IFN-??) or 10 mg/kg phytohemagglutinin A (PHA). Positive control substances capable of inhibiting phagocytic ability of macrophages include. 5 mg/kg dexamethasone or 200 mg/kg cyclophosphamide. Other fully-demonstrated positive control test
substances can also be used. The selection and application mode of positive control substances shall be determined according to the intended use of the test samples and the purpose of the test.
7.2 Negative control
The extraction medium (such as normal saline) recommended in GB/T
16886.12 is used and treated in the same way as the test sample.
Note. When there is a known marketed product which has a long-term clinical use history and of which the immunotoxicity level has been considered acceptable and the composition and intended use mode are the same as the test sample, it can also be used as a negative control, but its application requires a full demonstration. 8 Test procedures
8.1 Test grouping
for 30 min. After the incubation, RINSE in normal saline, to remove anchorage- independent cells. After drying, USE 1.1 acetone-methanol solution to fix it for 5 min, and USE 4% (volume fraction) Giemsa-phosphate buffer dye solution to stain for 3 min; FLUSH with running water; and RINSE with distilled water and DRY it.
9 Result calculation
The macrophages are counted under a microscope. Each slide is randomly
counted for 200. The phagocytic percentage and the phagocytic index of each animal shall be calculated according to the formulas (1) and (2).
Note 1. If the drop slide is too dark, it can be decolored with 1% HCl. If it is too light, it can be re-dyed.
Note 2. If the fluid drawn out of the peritoneal cavity is bloody exudate, it shall not be used. 10 Result judgement
When the test group and the negative control group show statistically significant difference in the phagocytic percentage and the phagocytic index, it can be considered that the test substance has an impact on the phagocytic function of mouse macrophages. If a gradient-diluted material or its extract is used for the test, and there is dose-effect relationship between the phagocytic percentage and the phagocytic index, it suggests that the phagocytic function of
macrophages may be affected.
11 Reliability inspection
11.1 The positive control is to, by using the substance which has been proven to promote or inhibit the phagocytic function of macrophages, confirm the suitability of the test. When it is necessary to verify that the laboratory is capable of performing this test and performing in-lab repeatability and interlaboratory reproducibility evaluations, positive control is recommended for each test. 11.2 For laboratories which frequently perform this test (Frequency is not less than once a month) and have long-term positive control data proving their ability Phagocytic
percentage
Phagocytic index
Number of macrophages which
phagocytose chicken erythrocytes
Total number of macrophages counted
Total number of chicken erythrocytes
which are phagocytosed
Total number of macrophages counted

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