GB 14232.1-2020Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (English PDF)

1 Scope

This section specifies the requirements (including performance requirements) for airtight, sterile plastic blood bags. Unless otherwise specified, all tests specified in this section

Suitable for plastic blood bags to be used.

This part is applicable to blood collection tubes, blood transfusion sockets, blood collection needles and transfer tubes (optional) for the collection, storage, and storage of blood and blood components.

Handling, transferring, separating and transfusing blood bags. This section also applies to multi-connected plastic blood bags, such as double-connected, triple-connected, quad-connected or multi-connected blood bags. according to

Use requirements, the blood bag can be filled with anticoagulant and/or maintenance solution.

This section does not apply to plastic blood bags integrated with the filter.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article

Pieces. For undated references, the latest version (including all amendments) applies to this document.

GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696.1987, MOD)

GB 8369.1 One-time use blood transfusion set Part 1.Gravity blood transfusion (GB 8369.1-2019, ISO 1135-4.2015,

MOD)

GB/T 14232.2 Bag-type plastic containers for human blood and blood components Part 2.Graphical symbols for labels and instructions

Number (GB/T 14232.2-2015, ISO 3826-2.2008, IDT)

GB 14232.3 Bag-type plastic containers for human blood and blood components. Part 3.Blood bag system with special components (GB 14232.3-

2011, ISO 3826-3..2006, IDT)

GB/T 16886 (all parts) Medical device biological evaluation series standards [ISO 10993 (all parts)]

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.Stimulus and Delayed Hypersensitivity 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 16886.12 Biological Evaluation of Medical Devices Part 12.Sample Preparation and Reference Samples (GB/T 16886.12-

2017, ISO 10993-12.2012, IDT)

YY/T 0466.1 Medical devices are used for medical device labeling, marking and information symbols. Part 1.General requirements (YY/T 0466.1-2016,ISO 15223-1.2012,IDT)

Pharmacopoeia of the People's Republic of China

GB/T 14233.2 | GB/T 14233.3 | GB/T 14233.1 | GB 14232.4 | GB 14232.3 | […]