GB/T 44831-2024General technical requirements of skin-on-a-chip (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 for standardization documents" Drafting.

Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.

This document was proposed and coordinated by the National Biochip Standardization Technical Committee (SAC/TC421).

This document was drafted by: Southeast University Suzhou Medical Device Research Institute, Southeast University, Biobio Group Co., Ltd., Jiangsu Aiweidesheng Technology Co., Ltd., Tsinghua University, Southern Medical University, Nanjing Food and Drug Administration, Nanjing Metrology Supervision and Inspection Institute, Suzhou University Health and Environmental Technology Research Institute Co., Ltd., Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Jiangsu Sports Health Research Institute, Jiangsu Provincial People's Government People's Hospital, China Food and Drug Inspection Institute, Jiangsu Provincial Center for Disease Control and Prevention, Changzhou Food and Drug Fiber Quality Supervision and Inspection Center, Wuxi Inspection, Testing and Certification Research Institute, China Academy of Information and Communications Technology, China Certification and Accreditation Association, West China Hospital of Sichuan University, Fudan University Affiliated Hospital It belongs to Huashan Hospital and Yunnan Beitanni Biotechnology Group Co., Ltd.

The main drafters of this document are: Gu Zhongze, Pu Yuepu, Cheng Jing, Yang Xingfen, Yang Jun, Chen Zaozao, Zhang Jing, He Zhini, Wang Shangjun, Ling Rui, Wang Lijie, Yin Ningbei, Lin Xueyong, Chen Hongfei, Xie Lan, Zhang Juan, Yu Wenlong, Liu Yun, Lu Yong, Lin Niu, Zhu Shan, Si Ni, Bian Qian, Gu Zhengrong, Wang Qin, Tao Lei, Lian Yunbo, Li Man, Ge Jianjun, Bai Jing, Wang Na, Li Li, Wu Wenyu, and Wang Feifei.

General technical requirements for skin chips

1 Scope

This document specifies the general technical requirements for skin microarrays and provides instructions for marking, labeling and accompanying documents, packaging, transportation and storage.

This document applies to the design, production and testing of skin chip products using microfluidic chips as carriers.

2 Normative references

GB/T 191

GB/T 2410

GB/T 2423.23-2013

GB/T 9969

GB/T 16886.5

GB/T 27990

GB/T 39514

3 Terms and Definitions

The terms and definitions defined in GB/T 27990, GB/T 39514 and the following apply to this document.