GB 14232.4-2021 Active National standards force_standard

GB 14232.4-2021 Plastics collapsible containers for human blood and blood components—Part 4:Aphaeresis blood bag systems with integrated features

GB 14232.4-2021 Plastics collapsible containers for human blood and blood components—Part 4:Aphaeresis blood bag systems with integrated features

Publish Date: 2021-12-01 Implement Date: 2023-06-01 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: GB 14232.4-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Blood transfusion, infusion, and injection equipment

Publish Date: 2021-12-01

Implement Date: 2023-06-01

Pages: 32 pages

Scope

This document specifies the requirements (including performance requirements) for single-donation blood bag systems containing special components. Single-donation blood bag systems include one or more special components as specified in this document.
These special components include:
—— Needle protection devices;
—— Leukocyte removal filters;
—— Sterile barrier filters;
—— Pre-donation sampling devices;
—— Red blood cell storage bags;
—— Plasma storage bags;
—— Platelet storage bags;
—— Polymorphonuclear (e.g., dried) cell storage bags;
—— Post-donation sampling devices;
—— Connectors for storage solutions, anticoagulants, and substitution solutions.
This document specifies additional requirements for blood bag systems used to collect different quantities of blood components or cells through single-donation separation.
This document applies to automatic or semi-automatic blood collection systems.

Development Information

Word Count: 60 Thousand words Pages: 32 pages

Referenced Standards

ISO 23908 中华人民共和国药典 GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB 8368-1998 Infusion sets for single use GB 8368-2005 Infusion sets for single use, gravity feed GB 8368-2018 Infusion sets for single use—Gravity feed GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed 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 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Adopt standards

ISO 3826-4:2015

Related Standards

GB/T 4506-1984 Abolished

GB/T 4506-1984 Method for the test of sharpness and strength of needles tips

Publish Date: 1984-06-22

GB/T 11751-1989 Abolished

GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension

Publish Date: 1989-10-20

GB/T 12256-1990 Abolished

GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing

Publish Date: 1990-01-08

GB/T 13074-1991 Replaced

GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration

Publish Date: 1991-07-17

GB 14232-1993 Abolished

GB 14232-1993 Bags for human blood and blood components

Publish Date: 1993-03-16

GB/T 14233.2-1993 Replaced

GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods

Publish Date: 1993-03-16