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

Standard No.

GB 14232.4-2021

Language

Chinese, Available in English version

Release Date

2021

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB 14232.4-2021

Scope

This document specifies requirements (including performance requirements) for single blood collection bag systems containing specific components. Single blood bag systems include one or more of the specific components given in this document. These special components refer to: - anti-acupuncture protection device; - leukocyte removal filter, - sterile barrier filter; - sampling device before blood collection; - red blood cell storage bag; - plasma storage bag; - platelet Storage bag; - polymorphonuclear (eg: and stem) cell storage bag; - sampling device after blood collection; - storage solution, anticoagulant and replacement fluid connectors. This document specifies additional requirements for blood bag systems used to collect variable quantities of blood components or cells by apheresis. This document applies to automatic or semi-automatic blood collection systems.

GB 14232.4-2021 Referenced Document

• GB 14232.4 Plastics collapsible containers for human blood and blood components—Part 4: Aphaeresis blood bag systems with integrated features
• GB 8368 Infusion sets for single use—Gravity feed
• GB 8369.1 Transfusion sets for single use—Part 1: Gravity feed
• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
• GB/T 6682 Water for analytical laboratory use.Specification and test methods
• ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
• ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 23908 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

GB 14232.4-2021 history

• 2021 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 -All Parts