| Autor: |
Tian H; Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299., Wu S; Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299., Liang Y; Shanghai Bisheng Consulting Co. Ltd., Shanghai, 201413., Wang W; Bisheng Medical Technology (Beijing) Co. Ltd., Beijing, 101299., Ji C; Shanghai Bisheng Consulting Co. Ltd., Shanghai, 201413. |
| Jazyk: |
čínština |
| Zdroj: |
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation [Zhongguo Yi Liao Qi Xie Za Zhi] 2023 May 30; Vol. 47 (3), pp. 328-331. |
| DOI: |
10.3969/j.issn.1671-7104.2023.03.020 |
| Abstrakt: |
This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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