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YY/T 1500-2016: Pyrogen test for medical devices. Monocyte-activation test. Human whole blood ELISA method
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| YY/T 1500-2016 | English | 199 |
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Pyrogen test for medical devices. Monocyte-activation test. Human whole blood ELISA method
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YY/T 1500-2016
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Basic data | Standard ID | YY/T 1500-2016 (YY/T1500-2016) | | Description (Translated English) | Pyrogen test for medical devices. Monocyte-activation test. Human whole blood ELISA method | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 10,135 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 16886.12 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the use of human whole blood ELISA method for the determination of pyrogen in medical devices/materials. | YY/T 1500-2016: Pyrogen test for medical devices. Monocyte-activation test. Human whole blood ELISA method
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Pyrogen test for medical devices.Monocyte-activation test.Human whole blood ELISA method
ICS 11.120.20
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device pyrogen test monocyte activation test
Human whole blood ELISA
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is based on the European Pharmacopoeia 7.0 monocyte activation test based on the combination of medical device products to develop.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Medical Device Standardization Technical Committee (SAC/TC248).
The drafting of this standard. Shandong Hengxin Detection Technology Development Center, Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Shanghai Songli Biotechnology has
Limited company.
The main drafters of this standard. Fan Chunguang, Wang Hong, Sun Likui, Liu Jiaxin, He Hongbing, Wu Xujun.
Introduction
Pyrogenic detection is an important item in the safety evaluation of medical devices. Medical devices Pyrogenic reactions are mainly divided into endotoxin-mediated heat
The original reaction and non-endotoxin-mediated pyrogenic reaction.
The pyrogen is divided into exogenous pyrogen and internal pyrogen. Common pyrogen is mostly outside the pyrogen, outside the pyrogen into the body can be activated after the body
(IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNFα), interleukin-
And so on. Within the pyrogen can be directly through the blood - brain barrier in the body temperature adjustment center so that the body temperature adjustment point on the move, the body heat increased,
Heat dissipation, causing heat.
Monocyte activation test (MAT) is used to activate human monocytes or mononuclear cells to release such as proinflammatory cytokines
, IL-1β, IL-6 and TNF-α, and the like. And these cytokines can cause fever
disease. Therefore, the MAT can detect the pyrogen present in the test sample. This guideline is given in Appendix A for guidelines for monocyte activation.
In.2009, the European Pharmacopoeia included in vitro pyrogen examination, the US FDA also received five kinds of human immune cells based on the injection of drug fever
In vitro test method. These methods use human whole blood, component blood or cell lines as a cell source, to detect the contact with the test substance after incubation
IL-1β, IL-6 and TNF-α and other internal pyrogen. International Organization for Standardization Technical Committee (ISO /TC194) 16 Working Group A document
It is stated that the detection of IL-6 and IL-1β has a higher signal-to-noise ratio and is a good cytokine pyrogenic marker. This standard is given in Appendix B
An example of human whole blood IL-1β method for thermoanometry of medical devices.
Medical device pyrogen test monocyte activation test
Human whole blood ELISA
1 Scope
This standard gives a test method for the determination of pyrogen in medical devices/materials by means of human whole blood ELISA.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples
3 Overview
Medical device/material after contact with human whole blood, the medical device/material contained in the pyrogen-activated blood in the mononuclear cells, activated
Mononuclear cells can produce endogenous pyrogen, such as IL-1β, IL-6 and TNFα. The intrahepatic pyrogen in the whole blood was measured by ELISA
And the response of the mononuclear cells to the test product and the response to the endotoxin standard, indirectly reflecting the medical device/material
The amount of pyrogenic substance contained.
4 full blood source and quality requirements
4.1 whole blood
Whole blood should meet the requirements of 4.2 and 4.3 for mixed whole blood.
4.2 Quality requirements for blood donors
Blood donors are required to meet the following eligibility criteria, subject to the relevant knowledge, health, safety and ethical compliance requirements. Offer
The blood should read the health condition well and have no bacterial or viral symptoms at least 1 week before blood donation. Blood donors do not have services within 48 hours of donation
Used non-steroidal anti-inflammatory drugs, and 7 days before donation did not take steroidal anti-inflammatory drugs. Taking an immunosuppressive agent or other known
People who can affect the drug to be read should not be used as a blood donor. Blood donation should be based on national blood transfusion requirements test blood infection markers.
4.3 Mixed blood quality requirements
Mixed whole blood should come from at least four blood donors, if feasible, preferably 8 or more blood donors, from each donor to take about the body
Plot the blood. The quality requirements are as follows. within 4 h after blood collection, at least 4 concentrations of endotoxin solution diluted with standard endotoxin
(E.g., in the concentration range of 0.01 IU/mL to 4 IU/mL) to draw a dose-response curve. The dose-response curve should meet the requirements of 7.2
Two criteria for the standard curve.
5 utensils
Use a confirmed process to remove all glassware and other heat-resistant devices in a dry-hot oven. Usually used for the time and temperature
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