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YY/T 0464-2019 Active Industry standards-Medicine

YY/T 0464-2019 Disposable hemoperfutor

YY/T 0464-2019 Disposable hemoperfutor

Publish Date: 2019-10-23 Implement Date: 2020-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0464-2019
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2019-10-23
Implement Date: 2020-10-01
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: 14 pages

Scope

本标准规定了一次性使用血液灌流器的术语和定义、分类与型号命名、要求、试验方法、标志与说明书及包装、运输、贮存。
本标准适用于采用活性炭或吸附树脂等吸附剂的一次性使用血液灌流器(以下简称灌流器)，灌流器配合血液净化装置供血液灌流使用，清除病人体内内源性和外源性药物、毒物及代谢产物。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、珠海健帆生物科技股份有限公司

Drafting Persons:

叶晓燕、何晓帆、张广海、罗洁伟、杜鸿雁、才建华、田冶

Word Count: 24 Thousand words Pages: 14 pages

Replace the following standards

YY 0464-2009 Disposable hemoperfutor

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 中华人民共和国药典(2015年版) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration GB/T 13074-2009 Terms of blood purification 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 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 13074-2024 Blood purification terminology GB/T 191-2025 Graphical symbols marking for handling and storage of packages

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08
GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26
GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17
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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