YY/T 1465.4-2017 (YY/T1465.4-2017, YYT 1465.4-2017, YYT1465.4-2017) & related versions
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Immunogenic evaluation method of medical devices—Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes—Ex-vivo method
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YY/T 1465.4-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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 γ interferon (IFN-γ) 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
......
| Standard ID | YY/T 1465.4-2017 (YY/T1465.4-2017) | | Description (Translated English) | Immunogenic evaluation method of medical devices--Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes--Ex-vivo method | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 10,188 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Sichuan Medical Devices Biological Materials and Products Inspection Center, Shandong Province Medical Device Product Quality Inspection Center | | Administrative Organization | National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC 248) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Standard ID | () | | Description (Translated English) | (Technical specifications for ceramic capacitive sensor type partial discharge monitoring devices of 35kV and below) | | Sector / Industry | Chinese Industry Standard | | Date of Issue | 2023-10-11 | | Date of Implementation | 2024-04-11 | | Issuing agency(ies) | National Energy Board | | Standard ID | () | | Description (Translated English) | (Technical specifications for ceramic capacitive sensor type partial discharge monitoring devices of 35kV and below) | | Sector / Industry | Chinese Industry Standard | | Date of Issue | 2023-10-11 | | Date of Implementation | 2024-04-11 | | Issuing agency(ies) | National Energy Board |
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