YY/T 1808-2021In vitro skin irritation test for medical devices (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

Introduction

Normal keratinocytes obtained from healthy volunteers are cultured at the air-liquid interface on film or filter paper for several days to form substrates including The three-dimensional skin model including the layer, spinous layer, granular layer and functional stratum corneum, namely the reconstructed human epidermis model. This model was originally designed to detect pure Chemicals were developed for external skin irritation. In recent years, such models have also been used to detect irritants in medical devices.

1 Scope

This document specifies a method for in vitro skin irritation testing of medical devices using a reconstructed human epidermis (RhE) model.

This document applies to the evaluation of potential skin irritation of medical devices by in vitro skin irritation tests using the RhE model.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 16886.10 Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Tests

GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials

3 Terms and Definitions

Terms and definitions defined in GB/T 16886.10 and GB/T 16886.12 apply to this document.

4 Test principle

The polar and non-polar extracts of the medical device/material or the device/material itself can directly contact the upper surface of the RhE model, and incubate for a certain amount of time.

After time, the test samples on the epidermis were removed by washing, and the RhE model cell activity was detected by the tetramethylazolium salt (MTT) test.

The tissue activity was obtained by comparing with the control, and the irritation of the test sample was predicted according to the tissue activity.

5 Materials