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This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.
This document replaces GB 19335-2003 Blood flow products for single use - General specification. In addition to structural adjustment and editorial changes, the following main technical changes have been made with respect to GB 19335-2003:
a) The clause “General requirements” is added (see Clause 4 and Annex A herein);
b) The requirements for “materials” are modified (see Clause 5 herein; 3.1 of Edition 2003);
c) The clause "General" is added (see 7.1 herein);
d) The requirements and test methods for "design” and "physical properties" (see Clause 6, 7.2 herein; 3.2 of Edition 2003) are modified, among which, the requirements for "injection parts", "connectors", "filters for blood and blood component ", "switch" and "particle contamination" (see 6.2 to 6.5 and 7.2.4 herein; 3.2.4 and 3.2.5 as well as 3.2.7 to 3.2.9 of Edition 2003) are mainly modified, the requirements for "air filter" are deleted (see 3.2.10 of Edition 2003), and the requirements for "pressure monitoring connector/sensor protector" are added (see 6.6 herein);
e) The requirements and test methods for chemical properties are modified (see 7.3 herein; 3.3 of Edition 2003);
f) The method for “Ethylene oxide residues” is modified (see 7.4 herein; 3.4 of Edition 2003);
g) The requirements for "biological properties" (see 7.5 herein; 3.5 of Edition 2003) are modified, among which, "pyrogen" and "hemolysis" are deleted (3.5.3 and 3.5.5 of Edition 2003), and the requirements for "sterility" (see 7.5.2 herein; 3.5.2 of Edition 2003) are modified, and the requirements for evaluation of "compatibility of blood in blood flow in fluid state" are added (see 7.5.4 herein);
h) The requirements for packaging and marking are modified (see Clause 8 herein; Clause 4 of Edition 2003);
i) “Method for testing the content of particles” is deleted (See Annex A of Edition 2003);
j) “Methods for testing self-sealing of injection parts” is deleted (See Annex B of Edition 2003);
k) "Method for testing the efficiency of filters for blood and blood components" is deleted (see Annex C of Edition 2003);
l) "Method for testing filtration rate of air filters" is deleted (see Annex D of Edition 2003);
m) “Method for analyzing ethylene oxide residues” is deleted (see Annex F of Edition 2003);
n) The "Requirements for design and evaluation" are added (see Annex A herein);
o) "Test methods for pressure monitoring connector/sensor protector" is added (see Annex B herein);
p) "Example of preparation of chemical property test solution" is modified (see Annex C herein; Annex E of Edition 2003);
q) "Guide for implementation of the standard" is added (see Annex D herein).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of SAC/TC 106 National Technical Committee on Medical Syringes of Standardization Administration of China.
The previous editions of this document and documents replaced by this document are as follows:
——It was first issued as GB 19335-2003 in 2003;
——This edition is the first revision.
Blood flow products for single use - General specification
1 Scope
This document specifies the general specification of blood flow products for single use.
This standard is applicable to blood flow for single use, as well as the auxiliary tubing connected with them, including products composed of fluid lines and pressure monitoring tubing (hereinafter referred to as “blood flow”).
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. 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 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
For the purposes of this standard, no terms and definitions apply.
4 General requirements
The blood flow products shall be designed with the established risk assessment procedures. In case the blood flow products are transported, stored, installed, properly used and maintained in accordance with the manufacturer's instructions, blood flow products shall not expose risks that have not been reduced to acceptable levels and are associated with their intended application under normal and single failure conditions if the risk management procedures conforming to YY/T 0316 are used.
The manufacturer shall give special consideration to additional risk control measures as the manufacturer may not be able to comply with all the requirements specified in this document.
See Annex A for the requirements for design and evaluation of blood flow products.
5 Materials
Pipelines that come into direct or indirect contact with blood should be made of materials that meet the requirements of relevant standards. The dissolved matter generated in the blood flow due to chemical or physical action of anticoagulants and/or preservative solutions, blood and blood components shall be within the prescribed limits.
Note: Refer to the bibliography for the standards about relevant materials of blood flow products.
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6 Design
6.1 Protective sleeves
All entrances and exits of the blood flow (except those of pressure monitoring connector/sensor protector) shall be provided with protective sleeves, which shall be firm and easy to remove.
6.2 Injection parts
6.2.1 Needless infusion access adapters
The needless infusion access adapters on the blood flow shall meet the relevant requirements of YY 0581.2.
The manufacturer should evaluate microbial ingress of needless access ports according to the requirements of YY/T 0923.
6.2.2 Needle infusion access adapters
The needle site of the needle infusion access adapters on the blood flow shall meet the relevant requirements of YY 0581.1.
6.3 Connectors
6.3.1 Luer connector
The Luer connector shall meet the requirements of ISO 80369-7.
6.3.2 Reservoir connector
The connector connected with citrate anticoagulants shall meet the requirements of ISO 18250-8: 2018.
The puncture outfit connected with other liquid bags and blood bags shall meet the requirements of GB 8369 (all parts).
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6.4 Filter nets for blood and blood components
If a filter used for blood and blood components is available in the direction of blood transfusion, it shall be designed in such a way that filtration is only allowed in the direction of blood transfusion.
The aperture of filter nets shall be uniform. If nylon filter nets are used, the filtering performance of the filter nets shall meet the requirements specified in YY/T 1288-2015.
6.5 Switch
The flow regulator in the blood flow shall meet the relevant requirements of GB 8369 (all parts).
In the intended use environment, the clamp in the blood flow shall be able to block the flow of liquid or gas when it is in service, and shall not damage the blood flow or hinder the flow of liquid or gas.
Note: The liquid or gas with a pressure of 50 kPa shall be used to verify the stop function of the clamp.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Design
7 Requirements
8 Packaging and marking
Annex A (Informative) Requirements for design and evaluation
Annex B (Normative) Test methods for pressure monitoring connector/sensor protector
Annex C (Informative) Example of preparation of chemical property test solution
Annex D (Informative) Guide for implementation of the standard
Bibliography
