GB 14232.4-2021Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (English PDF)
人体血液及血液成分袋式塑料容器 第4部分：含特殊组件的单采血袋系统
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Mandatory
Issue date
December 1, 2021
Implementation date
June 1, 2023
Scope
GB 14232.4-2021 is the English-translated version of 人体血液及血液成分袋式塑料容器 第4部分：含特殊组件的单采血袋系统.
GB 14232.4-2021 is the Chinese standard "Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features".
Its scope clause reads: This document specifies the requirements (including performance requirements) for a single blood collection bag system with special components.
The single blood bag system includes the One or more special components given.
These special components refer to. ---Acupuncture protection device; ---Leukocyte-removing filter; ---Sterile barrier filter; ---Sampling device before blood collection; ---Red blood cell storage bag; ---Plasma storage bag; ---Platelet storage bag; ---Polymorphic nuclear (e.g. stem) cell storage bag; ---Sampling device after blood collection; ---Connectors for storage fluid, anticoagulant and substitute fluid.
This document specifies additional requirements for blood bag systems used to collect different amounts of blood components or cells by apheresis separation. This document applies to automatic or semi-automatic blood collection systems.
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Document preview — GB 14232.4-2021
National Standard of the People's Republic of China
- Classification
- C 31
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 size
- 5 Design
- 5.1 Leukocyte-removing filter
- 5.2 Blood sample recognition
- 5.3 Collection needle and return needle
- 5.4 Anti-needle protection device
- 5.5 Sampling device before blood sampling
- 5.6 Red blood cell storage bag
- 5.7 Plasma storage bag
- 5.8 Platelet storage bag
- 5.9 Sampling device after blood collection
- 5.10 Transmission line
- 5.11 Blood transfusion socket
- 5.12 Hanging
- 6 Requirements
- 6.1 General requirements
- 6.2 Physical requirements
- 6.3 Chemical requirements
- 6.4 Biological requirements
- 7 Packaging
- 7.1 General
- 7.2 Shelf life
- 7.3 Outer packaging materials
- 7.4 Tightness of outer packaging
- 7.5 Strength of outer packaging
- 7.6 Placement of components in outer packaging
- 8 Label
- 8.1 General requirements
- 8.2 Labels on plastic blood bags
- 8.3 Outer packaging label
- 8.4 Package insert or instructions for use
- 8.5 Labels on the shipping box
- 8.6 Labeling requirements
- 9 Anticoagulant and/or maintenance fluid
- Appendix A (Normative) Physical Test
- Appendix B (Normative) Chemical Test
- Appendix C (Normative) Biological Test
- Appendix D (informative) Standard Implementation Guide
- References
1 Scope
This document specifies the requirements (including performance requirements) for a single blood collection bag system with special components. The single blood bag system includes the
One or more special components given.
These special components refer to.
---Acupuncture protection device;
---Leukocyte-removing filter;
---Sterile barrier filter;
---Sampling device before blood collection;
---Red blood cell storage bag;
---Plasma storage bag;
---Platelet storage bag;
---Polymorphic nuclear (e.g. stem) cell storage bag;
---Sampling device after blood collection;
---Connectors for storage fluid, anticoagulant and substitute fluid.
This document specifies additional requirements for blood bag systems used to collect different amounts of blood components or cells by apheresis separation.
This document applies to automatic or semi-automatic blood collection systems.
2 Normative references
The content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations
Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
This document.
GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696.1987, MOD)
GB 8368 Gravity infusion set for single-use infusion (GB 8368-2018, ISO 8536-4.2010, MOD)
GB 8369.1 Single-use blood transfusion set Part 1.Gravity blood transfusion (GB 8369.1-2019, ISO 1135-4.2015,
MOD)
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Test Selection for Interaction with Blood (GB/T 16886.4-2003,
ISO 10993-4.2002, IDT)
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test (GB/T 16886.5-2017,
ISO 10993-5.2009, IDT)
GB/T 16886.10 Biological Evaluation of Medical Devices Part 10.Irritation and Skin Sensitization Test (GB/T 16886.10-
2017, ISO 10993-10..2010, IDT)
GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test (GB/T 16886.11-2011,
ISO 10993-11.2006, IDT)
GB/T 14233.2 | GB/T 14233.3 | GB/T 14233.1 | GB 14232.1 | GB 14232.3 | […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB 8368Infusion sets for single use -- Gravity feed
- GB 8369.1Transfusion sets for single use -- Part 1: Gravity feed
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.4Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- GB/T 16886.5Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
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Related Standards
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 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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GB 14232.4-2021
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