Valid

GB 8369.2-2020Transfusion sets for single use - Part 2: With pressure infusion apparatus use (English PDF)

一次性使用输血器第2部分：压力输血设备用

Preview PDF

This is a limited preview

Buy now to download the full PDF (42 pages)

Need quotation for your management?

Get a formal quotation for GB 8369.2-2020 in 30 minutes.

Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Mandatory

Issue date

November 17, 2020

Implementation date

June 1, 2022

Scope

GB 8369.2-2020 is the English-translated version of 一次性使用输血器第2部分：压力输血设备用.

GB 8369.2-2020 is the Chinese standard "Transfusion sets for single use - Part 2: With pressure infusion apparatus use". Its scope clause reads: This part of GB 8369 specifies the use of single-use blood transfusion devices for blood transfusion equipment that can produce pressures of.200 kPa (2 bar) and below.

Material, physical, chemical and biological requirements. This section applies to blood transfusion sets used for pressure transfusion equipment that are used in conjunction with blood and blood component containers and intravenous injection equipment. Its clauses include terms and definitions.

Found what you need?

Document preview — GB 8369.2-2020

National Standard of the People's Republic of China

ICS: 11.040.20
Classification: C 31

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Naming of blood transfusion set components
4.2 Aseptic maintenance
5 Material
6 Physical requirements
6.1 Particulate pollution
6.2 Leak
6.3 Tensile strength
6.4 Transfusion port puncture
6.5 Pipeline
6.6 Blood and blood component filters
6.7 Drop Hopper and Dropper
6.8 Flow regulator
6.9 Flow rate of blood and blood components
6.10 Injection parts
6.11 Outer cone joint
6.12 Protective sleeve
6.13 Storage volume
7 Chemical requirements
7.1 Reducing substances (easy oxides)
7.2 Metal ions
7.3 Titration of pH
7.4 Evaporation residue
7.5 UV absorbance of extract
7.6 Residual ethylene oxide
8 Biological requirements
8.1 General
8.2 Sterile
8.3 Pyrogen
8.4 Hemolysis
8.5 Toxicity
8.6 Assessment of residual blood components
8.7 Assessment of blood component damage
9 sign
9.1 General
9.2 Single package
9.3 Shelf or multi-unit packaging
10 Packaging
11 Disposal
Appendix A (Normative Appendix) Physical Test
Appendix B (Normative Appendix) Chemical Test
Appendix C (Normative Appendix) Biological Test
Appendix D (Normative Appendix) Liquid Storage Volume
Appendix E (informative appendix) Design and Implementation Guidelines
Appendix F (informative appendix) Technical differences between this part and ISO 1135-5.2015 and their reasons

1 Scope

This part of GB 8369 specifies the use of single-use blood transfusion devices for blood transfusion equipment that can produce pressures of.200 kPa (2 bar) and below.

Material, physical, chemical and biological requirements.

This section applies to blood transfusion sets used for pressure transfusion equipment that are used in conjunction with blood and blood component containers and intravenous injection equipment.

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 document.

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

GB/T 6682-2008 Analytical laboratory water specifications and test methods (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 14232.1-2020 Bag-type plastic containers for human blood and blood components Part 1.Traditional blood bags (ISO 3826-1.2013, MOD)

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

GB/T 14233.1-2008 Medical infusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods

GB/T 14233.2 Medical infusion, blood transfusion, and injection equipment inspection methods Part 2.Biological test methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management

GB/T 25915.1 Clean room and related controlled environment Part 1.Air cleanliness grade

YY/T 0466.1 Medical devices are used for medical device labeling, marking and information symbols. Part 1.General requirements

YY/T 1288 Nylon blood filter for disposable blood transfusion apparatus

ISO 80369-7.2016 Small aperture connectors for medical liquids and gases-Part 7.Connectors for intravascular or subcutaneous applications

3 Terms and definitions

The following terms and definitions apply to this document.

Note. These terms and definitions are exclusively used in Appendix D.

GB 9706.224 | GB 8368 | GB 8662 | GB/T 2766 | GB 8369.1 | […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 42 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 3696.1987 · ISO 1135 · ISO 3826 · ISO 80369

How to Download GB 8369.2-2020

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.