YY 0465-2019 Active Industry standards-Medicine

YY 0465-2019 Disposable membrane plasmaseparator and plasma component separator

YY 0465-2019 Disposable membrane plasmaseparator and plasma component separator

Publish Date: 2019-05-31 Implement Date: 2020-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0465-2019
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: 2019-05-31
Implement Date: 2020-06-01
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: 18 pages

Scope

本标准规定了一次性使用空心纤维血浆分离器和血浆成分分离器的术语和定义、型式和型号命名、要求、试验方法、检验规则、标志及包装、运输、贮存。
本标准适用于一次性使用空心纤维血浆分离器和血浆成分分离器。一次性使用空心纤维血浆分离器(简称血浆分离器)配合血浆分离装置对各种免疫、代谢失调及某些中毒等疾病进行治疗。一次性使用空心纤维血浆成分分离器(简称血浆成分分离器)适用于实施双重滤过血浆交换治疗,与血浆分离器联用,通过膜分离方法,从分离出来的血浆中再分离一定相对分子质量的物质。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、广州康盛生物科技有限公司、佛山市博新生物科技有限公司

Drafting Persons:

吴静标、何晓帆、罗洁伟、叶晓燕

Word Count: 36 Thousand words Pages: 18 pages

Replace the following standards

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 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings 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 YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements GB/T 13074-2024 Blood purification terminology GB/T 191-2025 Graphical symbols marking for handling and storage of packages

Related Standards

Contact Us