GB/T 19335-2022 PDF in English
GB/T 19335-2022 (GB/T19335-2022, GBT 19335-2022, GBT19335-2022)
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Blood flow products for single use－General specification
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| GB 19335-2003 | English | 125 |
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Blood flow products for single use -- General specification
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Standards related to (historical): GB/T 19335-2022
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GB/T 19335-2022: PDF in English (GBT 19335-2022) GB/T 19335-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
Replacing GB 19335-2003
Blood flow products for single use - General specification
ISSUED ON: APRIL 15, 2022
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions... 6
4 General requirements ... 6
5 Materials ... 6
6 Design ... 6
7 Requirements ... 8
8 Packaging, marks ... 11
Annex A (informative) Design and evaluation requirements ... 12
Annex B (normative) Test methods for pressure monitoring joints/sensor protectors 14
Annex C (informative) Example for preparation of chemical performance test solution
... 17
Annex D (informative) Standard implementation guide ... 18
Bibliography... 19
Blood flow products for single use - General specification
1 Scope
This Standard specifies the general technical conditions for blood flow products for
single use.
This Standard applies to the blood flow products for single use and the auxiliary
pipelines connected to them, including the products composed of liquid flow and
pressure monitoring pipeline (hereinafter referred to as "blood flow").
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB 8369 (all parts), Transfusion sets for single use
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment 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 equipment for single use
YY/T 1556, Test methods for particle contamination of infusion, transfusion and
injection equipment for medical use
ISO 18250-8:2018, Medical devices - Connectors for reservoir delivery systems for
health care 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 that need to be defined in this document.
4 General requirements
It shall use the established risk assessment procedures to design the blood flow products.
When transporting, storing, installing, using and maintaining blood flow products in
accordance with the manufacturer's instructions, under normal and single failure
conditions, use risk management procedures in accordance with YY/T 0316. Blood
flow products shall not present risks that are not reduced to acceptable levels and are
associated with their intended use.
Manufacturers may not be able to comply with all the requirements identified in this
document, then manufacturers shall specifically consider additional risk control
measures.
See Annex A for the design and evaluation requirements of blood flow products.
5 Materials
The pipelines directly or indirectly in contact with blood shall be made of materials that
meet relevant standards. Leachables from the blood flow due to chemical or physical
effects of anticoagulants and/or maintenance fluids, blood and blood components shall
be within specified limits.
NOTE: See bibliography for relevant material standards for blood flow products.
6 Design
6.1 Protective cover
flow of fluids or gases.
NOTE: Use a liquid or gas with a pressure of 50kPa to verify the flow stop function of the stop clip.
6.6 Pressure monitoring joint/sensor protector
6.6.1 Appearance
The machine end of the pressure monitoring joint/sensor protector shall be transparent.
Blood contamination can be checked visually during use.
6.6.2 Barrier properties
Pressure monitoring joints/sensor protectors on the blood flow shall prevent
microorganisms from entering the pipeline. When tested in accordance with Annex B,
the filtration rate of the pressure monitoring joint/sensor protector for particles above
0.5μm in the air shall not be less than 90%.
NOTE 1: The YY/T 1551 series of standards provide test methods for evaluating bacterial retention
performance.
NOTE 2: This test is not required if the barrier material is non-breathable.
6.6.3 Pressure transfer performance
The pressure monitoring joint/sensor protector shall have adequate pressure
transmission performance. When the test is carried out according to B.2, the time
required for the pressure monitoring joint/sensor protector to transmit 10kPa air
pressure shall not exceed 3s.
6.6.4 Blood blocking
The filter material in the pressure monitoring joint/sensor protector can effectively
block the liquid. When tested according to B.3, under the hydraulic pressure of 40kPa
for 40s, there shall be no evidence of liquid penetration.
7 Requirements
7.1 General
Blood flows are designed to maintain high quality blood or blood components. The
blood flow is sterile and pyrogen-free under the expected conditions of use. It has
properties (such as transparency, softness, strength, fatigue resistance, sterilization
adaptability) that are compatible with its clinical use.
7.2 Physical properties
7.2.1 Appearance
The hose on the blood flow shall be plasticized evenly without kinks. Its transparency
shall allow detection of air bubbles in the bloodstream with normal or corrected vision.
7.2.2 Tightness
Seal each end of the blood flow. Immerse it in water at 20°C~30°C. Access the air
pressure of 50kPa or 1.5 times the maximum working pressure stated by the
manufacturer. Maintain 2min. There shall be no evidence of leakage.
NOTE: The blood flow with special requirements (if it needs to bear negative pressure), depends
on the specific situation.
7.2.3 Connection firmness
Each connection of the blood flow (excluding the protective sleeve) shall be able to
withstand a static axial tension of 15N. It shall last 15s without breaking and falling off.
7.2.4 Particulate pollution
Blood flows shall be produced with minimal particulate contamination. Liquid passage
surfaces shall be smooth and clean. When tested according to the method specified in
YY/T 1556, the pollution index shall not exceed 90.
NOTE: The volume of flushing fluid can be adjusted according to the product structure and intended
use.
7.2.5 Color code
When the blood flow is divided into arterial blood flow and venous blood flow, there
shall be a clear color mark within 100mm of the end of the pipeline. The arterial blood
flow shall be red. The venous blood flow shall be blue.
7.3 Chemical properties
7.3.1 Guide for test solution preparation
The preparation conditions of the chemical performance test solution shall represent the
most severe conditions for the clinical use of the product. Design the reasonable and
feasible extraction ratio, extraction temperature and extraction time. Prepare the blank
control solution in the same way.
The leaching method prioritizes the use of recycling methods. It shall represent the
maximum flow rate at which the product is intended to be used.
If the product contains containers or other components that are inconvenient to prepare
the test solution in a cyclic manner, the test solution can be prepared according to the
requirements in GB/T 14233.1-2008. Prepare the blank control solution in the same
If ethylene oxide is used for sterilization, when inspected according to Chapter 9 of
GB/T 14233.1-2008, the residual amount of ethylene oxide in blood flow products shall
meet the requirements specified in the product standard.
NOTE: The ethylene oxide residue index of blood flow products needs to be established on the
basis of biological evaluation.
7.5 Biological properties
7.5.1 General requirements
Blood flow products shall be biologically evaluated according to GB/T 16886.1.
7.5.2 Sterile
Blood flow products shall be supplied sterile and shall meet the requirements of YY/T
0615.1.
7.5.3 Bacterial endotoxin
Blood flow products shall control bacterial endotoxin content in corresponding product
standards. Carry out the test according to the test method given in GB/T 14233.2. It
shall not exceed 20EU/set.
7.5.4 Hemocompatibility of blood flow in the fluid state
If applicable, the mechanical force-mediated hemocompatibility of the blood flow shall
be evaluated.
If applicable, the blood flow shall be evaluated for residual blood components and blood
component damage under normal conditions of use.
NOTE: See YY/T 1620 and YY/T 1631 for the design evaluation test protocol.
8 Packaging, marks
The manufacturer of the blood flow shall provide evidence that its single package
complies with GB/T 19633.1.
NOTE: See also YY/T 0313.
Annex A
(informative)
Design and evaluation requirements
A.1 General
The following aspects are considered in the design of blood flow products:
a) Ensure that the blood or blood components maintain the required high quality.
b) As far as possible to ensure safe and efficient collection, testing, storage,
separation and transfusion of blood, especially the risk of minimization due to:
- Contamination, especially microbial contamination;
- Air embolism;
- Interaction between the blood flow and the blood.
c) When used in conjunction with other devices, the guaranteed function is
applicable.
A.2 Pump tubing
Manufacturers shall evaluate pump tubing in three areas:
- Matching with the supporting equipment to obtain accurate flow rate;
- or the shedding of particles during the use of the pump tube, refer to ISO/TR 19727
to design and evaluate the test plan;
- Durability, to ensure target flow rate is maintained throughout the process.
A.3 Residual amount of adhesive
The adhesive residue index shall be established on the basis of toxicological evaluation.
For blood flow products using cyclohexanone as a binder, see YY/T 1658 for the
evaluation method of cyclohexanone residue.
A.4 Dissolution amount of plasticizer
For blood flow products using plasticizers, the plasticizer dissolution index shall be
established on the basis of toxicological evaluation.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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