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YY/T 1920-2023 Active Industry standards-Medicine

YY/T 1920-2023 Blood compatibility tests of haemodialysers

YY/T 1920-2023 Blood compatibility tests of haemodialysers

Publish Date: 2023-09-05 Implement Date: 2024-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1920-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Health
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2023-09-05
Implement Date: 2024-09-15
Publisher: 国家药品监督管理局
Technical Committee: 全国医用体外循环设备标准化技术委员会(SAC/TC 158)
Pages: 12 pages

Scope

本文件规定了透析器血液相容性的试验方法。本文件适用于以中空纤维膜为主体的血液透析器、血液滤过器、血液浓缩器等医疗器械的血液相容性试验。

Development Information

Drafting Units:

中国食品药品检定研究院、广东省医疗器械质量监督检验所、河南省药品医疗器械检验院

Drafting Persons:

许建霞、杨文润、杨立峰、刘康博、莫晓彦、孟星、罗洁伟、田莉艳

Word Count: 23 Thousand words Pages: 12 pages

Referenced Standards

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Related Standards

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GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01
GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25
GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04
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