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
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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
Pages: 18 pages

Scope

This standard specifies the terms and definitions, types and model names, requirements, test methods, inspection rules, marking and packaging, transportation, and storage of disposable hollow fiber plasma separators and plasma component separators.
This standard applies to disposable hollow fiber plasma separators and plasma component separators. Disposable hollow fiber plasma separators (referred to as plasma separators) are used in conjunction with plasma separation devices to treat various diseases such as immunological and metabolic disorders and certain poisonings. Disposable hollow fiber plasma component separators (referred to as plasma component separators) are suitable for implementing double filtration plasma exchange therapy. When used in conjunction with plasma separators, they separate certain substances with a specific molecular weight from the separated plasma through membrane separation methods.

Development Information

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

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