[Current Progress on Biological Evaluation for Medical Devices]

Chenghu Liu; Yanping Shi; Li Hou; Xiaoxia Sun

doi:10.3969/j.issn.1671-7104.2021.01.015

[Current Progress on Biological Evaluation for Medical Devices]

Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Feb 8;45(1):72-75. doi: 10.3969/j.issn.1671-7104.2021.01.015.

[Article in Chinese]

Authors

Chenghu Liu¹, Yanping Shi¹, Li Hou¹, Xiaoxia Sun¹

Affiliation

¹ Shandong Quality and Inspection Center for Medical Devices;NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging;NMPA Key Laboratory for Quality Control of Pharmaceutical Packaging;Shandong Provincial Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101.

PMID: 33522181
DOI: 10.3969/j.issn.1671-7104.2021.01.015

Abstract

To broadly understand the new direction of biological evaluation for medical devices, we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation, toxicological risk evaluation, evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.

Keywords: biological evaluation; medical device; regulatory science; risk management.

MeSH terms

Equipment and Supplies*