GB 12264-1990
Replaced
YY/T 0464-2019
Active
Industry standards-Medicine
YY/T 0464-2019 Disposable hemoperfutor
YY/T 0464-2019 Disposable hemoperfutor
Price:
$ 48
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
Pages:
14 pages
Scope
This standard specifies the terms and definitions, classification and model naming, requirements, test methods, marking and instructions, and packaging, transportation, and storage of disposable blood perfusion devices.
This standard applies to disposable blood perfusion devices (hereinafter referred to as perfusion devices) that use adsorbents such as activated carbon or adsorption resins. The perfusion devices are used in conjunction with blood purification devices for blood perfusion to remove endogenous and exogenous drugs, toxins, and metabolic products from the patient's body.
Development Information
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 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 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced