GB/T 19335-2022Blood flow products for single use — General specification (English PDF)
一次性血液循环产品 — 一般规格
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Issued by
SAC; SAMR
Level / Type
National · Recommended
Issue date
April 15, 2022
Implementation date
May 1, 2023
Scope
GB/T 19335-2022 is the English-translated version of 一次性血液循环产品 — 一般规格.
The general specifications of blood flow products for single use. This document applies to single-use blood flows and their integrated accessory lines, including products consists of liquid lines and pressure monitoring lines, etc. (hereinafter referred to as “blood flow”).
Document preview — GB/T 19335-2022
National Standard of the People's Republic of China
- ICS
- 11.040.20
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 5 Materials
- 6 Design
- 7 Requirements
- 8 Packaging, logo
- Appendix A Design and Evaluation Requirements
- Appendix B Test Method for Pressure Monitoring Connector / Transducer Protector
- Appendix C Example of Chemical Property Test Solution Preparation
- Appendix D Standard Implementation Guide
1 Scope
This document specifies the general specifications of blood flow products for single use. This document applies to single-use blood flows and their integrated accessory lines, including products consists of liquid lines and pressure monitoring lines, etc. (hereinafter referred to as “blood flow”).
2 Normative references
The contents of the following documents constitute essential provisions of this document through the normative references in the text. Among them, only the version corresponding to the date applies to this document for references dated, and its latest version (including all modification orders) applies to this document for references not dated. GB 8369 (all parts) Transfusion sets for single use GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems YY/T 0316 Medical devices - Application of risk management to medical devices YY 0581.1 Infusion access adapters - Part 1: Needle access adapters (Heparin plugs) YY 0581.2 Infusion access adapter - Part 2: Needleless access adapters YY/T 0615.1 Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices YY/T 0923 Needleless access ports for fluid lines and blood lines - Test method for microbial ingress YY/T 1288-2015 - Nylon blood filter nets for transfusion equipments for single use YY/T 1556 Test methods for particle contamination of infusion, transfusion and injection equipments for medical use ISO 18250-8:2018 Medical devices—Connectors for reservoir delivery systems for healthcare applications— Part 8: Citrate-based anticoagulant solution for apheresis applications ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications —Part 7: Connectors for intravascular or hypodermic applications
3 Terms and definitions
There are no terms and definitions to be defined in this document.
4 General requirements
Established risk assessment procedures shall be used to design blood flow products. When blood flow products are transported, stored, installed, used normally and maintained in accordance with the manufacturer’s instructions, no risks that are not reduced to an acceptable level and are relevant to its intended application shall be identified under normal and single-failure conditions, using risk management procedures in accordance with YY/T 0316.
The manufacturer shall give special consideration to additional risk control measures since they may not be able to follow all the requirements identified in this document.
See Appendix A for the design and evaluation requirements for blood flow products.
5 Materials
The lines directly or indirectly in contact with blood shall be manufactured by choosing materials that meet the relevant standards. Lysates from the blood flow due to chemical or physical action by anticoagulants and/or maintenance solution, blood and blood components shall be within the specified limits.
6 Design
6.1 Protective cap
Each inlet and outlet of the blood flow (except for the inlet and outlet of the pressure monitoring connector / transducer protector) shall be provided with a protective cap that is secure and easy to remove.
6.2 Injection parts
6.2.1 Needleless injection parts
Needleless injection parts on the blood flow shall meet the relevant requirements of YY 0581.2. Manufacturers are advised to evaluate the microbial ingress of the needleless access ports in accordance with YY/T 0923.
6.2.2 Needle injection parts
The puncture site of the needle injection parts on the blood flow shall comply with relevant requirements of YY 0581.1.
6.3 Connectors
6.3.1 Luer connectors
Luer connectors shall conform to the requirements of ISO 80369-7.
6.3.2 Reservoir connectors
Connectors to the citrate anticoagulant shall conform to the requirements of ISO 18250-8:2018. The puncture outfit connected to other fluid bags and blood bags shall comply with the requirements of GB 8369 (all parts).
6.4 Blood and blood component filter net
In case blood and blood component filters are available in the direction of transfusion, the blood flow products shall be designed to allow filtration only in the direction of transfusion. The filter mesh shall be uniform, and the filter performance of the filter mesh shall meet the requirements specified in YY/T 1288-2015 if nylon filter mesh is used.
6.5 Switch
The flow regulator in the blood flow shall comply with the relevant requirements of GB 8369 (all parts).
In the intended use environment, the restraint clamp in the blood flow shall be able to block the flow of liquid or gas during use and shall not damage the blood flow or impede the flow of liquid or gas.
6.6 Pressure monitoring connector / transducer protector
6.6.2 Barrier performance
The pressure monitoring connector / transducer protector on the blood flow shall be able to prevent microorganisms from entering the line. When tested in accordance with Appendix B, the filtration efficiency of the pressure monitoring connector / transducer protector for particles above 0. […]
7 Requirements
7.1 General provisions
The blood flow is designed to maintain high-quality blood or blood components. The blood flow shall be sterile and pyrogen-free under the intended conditions of use and provided with properties appropriate to its clinical use (e.g., transparency, flexibility, strength, fatigue resistance, sterilization adaptability, etc.).
7.2 Physical properties
7.2.1 Appearance
The hose on the blood flow shall be evenly plasticized and free of kinks, and its transparency shall be such that bubbles in the blood flow can be detected with normal vision or corrected vision.
7.2.2 Integrity
After sealing each end of the blood flow, immersing in water at 20°C-30°C and passing through an air pressure of 50 kPa or 1.5 times the manufacturer’s nominal maximum working pressure for 2 min, no signs of leakage shall be observed. determined on a case-by-case basis.
7.2.3 Connection firmness
Each connection of the blood flow (excluding the protective cap) shall be able to withstand a static axial tensile force of 15 N, lasting 15 s without fracture and fall off.
7.2.5 Color code
When the blood flow is divided into arterial and venous blood flows, there shall be a clear color marking within 100 mm of the end of the line. […]
7.3 Chemical properties
7.3.1 Test solution preparation guide
Test solution preparation conditions for chemical properties shall represent the most demanding situation of the product in clinical use, designing a reasonable and feasible extraction ratio, extraction temperature and extraction time, and preparing a blank control solution with the synchronization method. For the extraction method, preference shall be given to the use of circulation, which is appropriate to represent the maximum flow rate at which the product is expected to be used. If the product contains a container or other components with the use of circulation to prepare the test solution not facilitated, test solution can be prepared according to the requirements of GB/T 14233. […]
7.5 Biological properties
8 Packaging, logo
The manufacturer of the blood flow shall provide evidence that its single package complies with GB/T 19633.1.
Appendix A Design and Evaluation Requirements
A.1 General provisions
The following aspects of the design regarding blood flow products shall be considered: a) Ensure that the blood or blood components maintain the high quality required. b) Ensure that blood is collected, tested, stored, separated and transfused as safely and effectively as possible, in particular with the minimization of risks arising from:
-contamination, especially microbial contamination; -aeroembolism; -interaction between blood flow and blood. c) Ensure that the functions are applicable when used in conjunction with other devices.
A.2 Pump tube
The manufacturer shall evaluate the pump tube in three areas: -- matchability with the auxiliary equipment, to obtain accurate flow rates; […]
A.3 Adhesive residual
Indicators of adhesive residuals shall be based on the toxicological evaluation. For blood flow products using cyclohexanone as adhesives, the evaluation method of cyclohexanone residuals is shown in YY/T 1658.
Appendix B Test Method for Pressure Monitoring Connector / Transducer Protector
B.1 Filtration rate test method
B.1.1 Test instrument
Dust particle counter: The length of the sampling tube is 1 m, and the sampling frequency is 1 time/min. Rotor flow meter: The range is 80 mL/min or 100 mL/min.
B.1.2 Test procedure
Connect the dust particle counter to a flow meter under static ambient conditions, measure the number of particles of 0.5 μm and above in the air collected within 1 min at an air flow rate of 50 mL/min, and take 5 consecutive values. […]
B.2 Pressure propagation performance test method
B.2.1 Cut off the pressure monitoring connector / transducer protector and connect it to the two spring-loaded sphygmomanometers (full range of 40 kPa) and the compression units consisting of 5 and 6 according to Figure B.1, with both sphygmomanometer pointing to 0 position at this point. B.2.2 Close switch 3, quickly operate the pressurized airbag 6 to raise the pressure of sphygmomanometer 4 to 10.5 kPa, stop pressurization and keep the pressure constant, quickly open switch 3 while timing, and observe the pointer of sphygmomanometer 1. […]
Appendix C Example of Chemical Property Test Solution Preparation
C.1 Take a sterilized blood flow of 4 m and connect it to a 500 mL glass flask to form a closed circulation system, fill the flask with water of 250 mL (in line with GB/T 6682) and keep it at 37 °C ± 1 °C, apply a peristaltic pump to the shortest possible section of silicone rubber pump pipe to circulate water at a flow rate of 1 L/h for 2 h, and collect all the liquid and cool, so as to obtain the test solution. Use the same batch of water to prepare a blank control liquid by circulating as the above steps without connecting the sample on the return path.
C.2 Prepare the test solution by a special peristaltic pump acting directly on the pump pipe according to the conditions of C.1 if the sample contains a pump pipe. Add water of 250 mL to a glass flask of 500 mL and keep it at 37°C±1°C for 2 h to obtain the blank control liquid.
C.3 Mix various parts of the test solution to make the sample test solution. separately, the test solution of each part can be tested separately.
Remaining clauses in the full document
- Appendix D Standard Implementation Guide
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0923Test method for microbial ingress on infusion access adapters for fluid and blood lines
GB 8369 · GB/T 19633.1 · YY/T 0316 · YY 0581.1 · YY 0581.2 · YY/T 0615.1 · YY/T 1288-2015 · YY/T 1556 · ISO 18250 · ISO 80369
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-2025 — Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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