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YY/T 1808-2021: (In vitro skin irritation test for medical devices)
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Basic data | Standard ID | YY/T 1808-2021 (YY/T1808-2021) | | Description (Translated English) | (In vitro skin irritation test for medical devices) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 11,180 | | Issuing agency(ies) | State Drug Administration | YY/T 1808-2021: (In vitro skin irritation test for medical devices)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(In vitro skin irritation test for medical devices)
ICS 11.040.01
CCSC30
People's Republic of China Pharmaceutical Industry Standard
In vitro skin irritation test for medical devices
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
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.
Please note that some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248).
This document is drafted by. Shandong Medical Device Product Quality Inspection Center, China National Institute for Food and Drug Control, Beijing Medical Device
Inspection Institute, Jinan Pansheng Biotechnology Co., Ltd.
The main drafters of this document. Fan Chunguang, Liu Jia, Chen Liang, Wang Rui, Xing Zhiqing, Chen Liyuan, Dai Zhengning, Zhang Ping.
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.
In vitro skin irritation test for 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
5.1 RhE model
Experiments were performed using a commercial RhE model. See Appendix A for a description of the RhE model.
Epidermal cells should be obtained from healthy volunteers who are negative for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis C antibodies, hepatitis B and other antigens.
By. Users of this document should establish appropriate safety and health procedures to ensure biosecurity.
5.2 Instruments and equipment
The equipment is as follows.
a) Ultra-clean workbench.
b) Biological safety cabinet.
c) Cell incubator.
d) Balance.
e) Microplate reader.
f) Horizontal shaker.
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