YY/T 0879.2-2015Test for hypersensitivity of medical devices - Part 2: Murine Local Lymph Node Assay (LLNA):BrdU-ELISA method (English PDF)

Foreword

YY/T 0879 "Medical Devices sensitization test" intended to divide part of the publication, currently plans to release the following components.

--- Part 1. local lymph node assay (LLNA) mouse;

--- Part 2. local lymph node assay (LLNA) mouse BrdU-ELISA method. This section YY/T Section 20879 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

Introduction

YY/T 0879.1 in the use of radioactive thymidine incorporation of uridine or method to detect sensitization potential of medical devices, It can be used to partially replace GB/T 16886.10 specified in the guinea pig sensitization test. But in the purchase, use or waste radioactive material handling Difficult areas, use of the test subject to certain restrictions. This part is LLNA method improvement, non-radioactive, and has After international independent scientific assessment team confirmed the blind, evaluation, and recommended as there are some limitations of the test for identifying skin sensitizing substance method.

And YY/T 0879.1 similar to this part of the study of the induction phase of skin sensitization and provides a suitable dose-response assessment of quantitative data.

And may not be used for radioactive labeled DNA, eliminating occupational exposure and radioactive waste disposal problems. Meanwhile, the ratio of part Skin sensitization test using guinea pigs in an amount less inspire challenges induction phase of skin sensitization reactions inside do not need. And not like the guinea pig The maximum dose tested as an adjuvant to reduce the suffering of animals. More in line with GB/T 16886.2 requirements.

This section does not necessarily apply to all of the test substance. For example, when some of the metal test, found that some skin irritation because the surface contains (Such as surfactant) and this substance is soluble, it will make the results were false positive. In addition, the test substance or containing certain categories Have indicated that substance as a potential confounders functional groups may also require the use of guinea pig sensitization test. Meanwhile, YY/T 0879.1 identified A limitation also applies to this section. Before using this section, the laboratory should consider all available information on the test substance, including The name and the chemical structure of the test substance including physical and chemical properties, and any other in vivo or in vitro toxicity test results and the number of structurally related toxicology According to determine whether this section applies to the test substance, and help for the test substance dose selection.

In addition, when the stimulation index (SI) is between 1.6 and 1.9 should be considered critical positive possibilities. However, since the phase The same data set to set the SI value and used to calculate the ability to identify the test results described may overestimate the actual recognition.

1 Scope

YY/T 0879 gives this part of the medical device or test methods for materials sensitization reactions.

This section is expected to provide an alternative method to the guinea pig sensitization test, with certain limitations, before use of the method should be applicable Of confirmation.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements

GB/T 16886.10 Biological evaluation of medical devices - Part 10.

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

3 Terms and Definitions

GB/T 16886.1 terms and definitions GB/T 16886.2 and GB/T 16886.10 defined apply to this document.

4 Test principle

Lymphocyte proliferation in the medical device sensitizing agent may be induced sites draining lymph nodes. The proliferation sensitizing agent used The dosage and sensitizing potential proportional to, thus providing a simple access method for quantitative measurement of sensitization. BrdU is a thymidine Glycoside analogs may be incorporated into the DNA of proliferating cells. Test methods for measuring animal ear by enzyme-linked immunosorbent assay (ELISA)

The amount of BrdU incorporated within the draining lymph nodes to indicate the increase in the number of proliferating cells, proliferation and use than the average volume of the test group and the control group (SI) to assess proliferation can be measured to determine the allergenic potential of substances. Description 5 Test Method