YY/T 0879.1-2013Test for sensitization of medical devices - Part 1: Murine local lymph node assay (LLNA), radioisotope incorporation method (English PDF)

Foreword

YY/T 0879 the general title "Medical Device sensitization test", includes the following components.

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

For additional aspects of sensitization test will have the rest of the standard. This section drafted in accordance with GB/T 1.1-2009 given rules.

YY/T 0879 this part of the reference ASTM F2148-2007 "using the local lymph node assay (LLNA) mouse evaluate delayed access Standard Specification for "the development of contact hypersensitivity.

Introduction

Material component of medical devices, processing aids or cleaning and sterilization residues may trigger the body's hypersensitivity occur.

GB/T 16886.10 recommended three measuring medical equipment skin sensitization potential of animal tests, including the maximum dose tested in guinea pigs (GPMT), closed-end sticking test (Buehler test) and local lymph node assay (LLNA) mouse. GB/T 16886.10 not given LLNA method steps.

At present the international community as the only alternative has been accepted LLNA test guinea pig test was used to test a single chemical, the preferred chemical measurement law. Compared with guinea pig sensitization test, LLNA has the following advantages.

a) test cycle is short. LLNA total period of seven days, and the guinea pig sensitization test is required 24 days.

b) the required test animals is smaller. In contrast, LLNA more in line with GB/T 16886.2 animal welfare requirements.

c) LLNA response data can be quantitative stimulus, rather than subjective evaluation can be used to determine the dose-response, and provides system can be Total Learning objective data analysis.

Sensitized guinea pigs is similar to the reaction, LLNA is preferred for a single chemical sensitization potential test. LLNA detected in the early (induction Guide) sensitization process, and guinea pig sensitization test is detected at a later stage (excitation) of the sensitization process. Can not penetrate the skin of certain metals and scores Molecular weight of the test sample false-negative and false-positive cases, you may need to evaluate the guinea pig test its potential allergenicity. YY/T 0879 of This section requires the use of radioisotopes. Therefore encouraged to find alternatives to radioactive isotopes, when the new method is confirmed,

YY/T 0879 of this section can be used.

1 Scope

This section YY/T 0879 gives medical equipment/materials sensitization detection tests.

This section is expected to provide an alternative method to the guinea pig sensitization test, especially for contact with intact skin only to medical devices/materials.

However, when the assessment or a metal material used for sensitization deep tissue or damage the surface of medical products/materials, the dolphin is still recommended Rat sensitization test.

This section only applies to the skin can be immersed in a low molecular weight chemicals that absorb chemicals or metabolites can bind to macromolecules, such as Proteins to form immunogenic complexes.

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 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity

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 Abbreviations

The following abbreviations apply to this document. AOO. olive oil solution of acetone (4.1 volume ratio)

DMSO. dimethyl sulfoxide

DNCB. 2,4 dinitrochlorobenzene

ICCVAM. Inter-Agency Coordinating Committee evaluated alternatives

PBS. phosphate buffer (pH 7.2)

TCA. 5% TCA 3H-TdR. 3H- thymidine, 7.4 x 10^10Bq/mm (2Ci/mM) (PBS medium); I125IUDR-I125 radioactive uracil Nucleosides