YY 1290-2016 Active Industry standards-Medicine

YY 1290-2016 Single use bilirubin plasma hemoperfutor

YY 1290-2016 Single use bilirubin plasma hemoperfutor

Publish Date: 2016-03-23 Implement Date: 2018-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 1290-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical instruments and materials

Publish Date: 2016-03-23

Implement Date: 2018-01-01

Pages: 9 pages

Scope

This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marking and user's manual, as well as packaging, transportation, and storage for disposable bilirubin plasma adsorbers (hereinafter referred to as adsorbers).
This standard applies to disposable bilirubin plasma adsorbers. The adsorbers use plasma separators and blood purification support systems to extract blood from patients with hyperbilirubinemia, separate the plasma using plasma separators, and perform plasma adsorption to reduce the bilirubin level in the plasma.

Development Information

Word Count: 15 Thousand words Pages: 9 pages

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods YY 0464-2009 Disposable hemoperfutor 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

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Publish Date: 1988-02-13

GB 2766-1995 Replaced

GB 2766-1995 Haemostatic forceps with box joint—General specifications

Publish Date: 1995-06-02

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GB 9706.4-1999 Replaced

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Publish Date: 1999-08-02

YY 0464-2003 Replaced

YY 0464-2003 Single use hemoperfutor

Publish Date: 2002-06-20

YY 0054-2003 Replaced

YY 0054-2003 Haemodialysis、haemodiafiltration and haemofiltration equipment

Publish Date: 2003-06-20