Discussion on requirements for preclinical and clinical research on single-use hemodialyzers

DENG Jie

doi:10.3969/j.issn.1671-4091.2011.04.00

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Chinese Journal of Blood Purification >

2011 , Vol. 10 >Issue 4: 224 - 227

DOI: https://doi.org/10.3969/j.issn.1671-4091.2011.04.00

血液净化相关产品与技术

Discussion on requirements for preclinical and clinical research on single-use hemodialyzers

DENG Jie

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Center for Medical Device Evaluation of SFDA, Beijing 100044, China.e-mail: dengjie@cmde.org.cn

Received date: 2011-01-28

Revised date: 1900-01-01

Online published: 2011-04-12

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Abstract

【Abstract】 This paper discusses preclinical research on hemodialyzers, including standards for hemodialyzer membranes, product control, biological evaluation, process control, and allowable limits for leachable substances. This paper also analyzes the requirements for clinical research on hemodialyzers, the key points to safety and efficacy evaluation of hemodialyzers, and the common questions from clinical researches.

Key words： Preclinical research; Clinical research

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DENG Jie . Discussion on requirements for preclinical and clinical research on single-use hemodialyzers[J]. Chinese Journal of Blood Purification, 2011 , 10(4) : 224 -227 . DOI: 10.3969/j.issn.1671-4091.2011.04.00

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