YY/T 1758-2020Cardiovascular implants—Pulmonary valve conduit (English PDF)
心血管植入物 肺动脉带瓣管道
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 27, 2020
Implementation date
September 1, 2021
Scope
YY/T 1758-2020 is the English-translated version of 心血管植入物 肺动脉带瓣管道.
YY/T 1758-2020 is the Chinese pharmaceutical industry standard that sets the basic requirements for the pulmonary valve conduit, the valved tube implanted to correct or reconstruct the right ventricular outflow tract.
It covers the intended performance and the design attributes, the materials and their evaluation, the hydrodynamic and durability testing of the valve, the strength of the conduit and of its anastomoses, the packaging and sterilization, and the information the manufacturer must supply. Issued on 27 September 2020, it has applied since 1 September 2021.
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Document preview — YY/T 1758-2020
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions5
- 4 Raw material5
- 5 Requirements6
- 6 Test method8
- 7 Packaging, marking, transportation and storage12
1 Scope
This Standard specifies the basic requirements for pulmonary valve conduit.
This Standard applies to the pulmonary valve conduit which corrects or reconstructs the ventriculus dexter outflow tract.
This Standard does not apply to prostheses which are derived from allogeneic and autologous tissues (autologous transplantation).
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191, Packaging - Pictorial marking for handling of goods
GB/T 9969, General principles for preparation of instructions for use of industrial products
GB 12279, Cardiovascular implants - Cardiac valve prostheses
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2-2005, 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 16886.12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
YY/T 0313, Medical polymer products - Requirement for package and information supplied by manufacturer
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY 0500-2004, Cardiovascular implants - Tubular vascular prostheses
5 Requirements
5.1 Physical properties
5.1.1 Appearance
The pulmonary valve conduit shall be well-defined and complete; the surface shall be clean and free of flaws, spots, and other defects that affect its use.
5.1.2 Specifications
The inner diameter and length of the pulmonary valve conduit shall meet the manufacturer's specifications.
5.1.3 External durability
Perform the in vitro accelerated fatigue test for 2.0 x 10^8 cycles to evaluate the performance of pulsating flow in vitro; the results shall meet the manufacturer's specifications. The valve leaflet shall be undamaged.
5.1.4 Fluid dynamics
5.1.4.1 Steady-state forward flow test
The results of the steady-state forward flow test of the pulmonary valve conduit shall meet the manufacturer's specifications.
5.1.4.2 Steady-state leakage test
The steady-state leakage test results of the pulmonary valve conduit shall meet the manufacturer's specifications.
5.1.4.3 Pulsating flow test
The pulsating flow test results of the pulmonary valve conduit shall meet the manufacturer's specifications.
5.1.5 Valve opening and closing state
The valve leaflets of the pulmonary valve conduit shall be opened and closed completely.
5.1.6 Expanded inner diameter
Under the pressure of 8 kPa (60 mmHg), the expanded inner diameter of the valve of the pulmonary valve conduit shall meet the manufacturer's specifications.
5.2.1 pH value
Compare the test solution with the blank solution of the same batch; the difference in pH value shall not exceed 1.5.
5.2.2 Heavy metal
The total content of heavy metals in the test solution shall not exceed 1 µg/mL.
5.2.3 Residues
The manufacturer shall clarify chemical treatment and modification methods, and give acceptance criteria for residual substances.
5.2.4 Other chemical properties
If the product contains non-biological components, its chemical properties shall be evaluated.
5.3 Biological properties
5.3.1 Sterility
The pulmonary valve conduit shall be sterile.
5.3.2 Bacterial endotoxin
The bacterial endotoxin of the pulmonary valve conduit shall be less than 2.15 EU/piece.
5.3.3 Pyrogen
Pulmonary valve conduit shall not cause pyrogen reactions.
5.3.4 Calcification
Implant the pulmonary valve conduit subcutaneously for 8 weeks, and the calcium content shall not be higher than the reference substance.
5.3.5 Biocompatibility
Pulmonary valve conduit shall be biologically evaluated in accordance with GB/T 16886.1.
6 Test method
6.1 Physical test
6.1.1 Appearance
Perform the test in accordance with the method that is specified in 8.3.1 of YY 0500-2004; the result shall meet the requirements of 5.1.7.1.
6.1.7.2 Axial tensile strength
Perform the test in accordance with the method that is specified in 8.3.2 of YY 0500-2004; the result shall meet the requirements of 5.1.7.2.
6.1.8 Conduit bursting strength
Perform the test in accordance with the method that is specified in 8.3.3 of YY 0500-2004; the result shall meet the requirements of 5.1.8.
6.1.9 Conduit pulling strength
Perform the test in accordance with the method that is specified in 8.8 of YY 0500-2004; the results shall meet the requirements of 5.1.9.
6.1.10 Conduit water permeability
Perform the test in accordance with the method that is specified in 8.2 of YY 0500-2004; the result shall meet the requirements of 5.1.10.
6.1.11 Wall thickness
Perform the test in accordance with the method that is specified in 8.7 of YY 0500-2004; the result shall meet the requirements of 5.1.11.
6.1.12 Kinking diameter
Perform the test in accordance with the method that is specified in 8.9 of YY 0500-2004; the result shall meet the requirements of 5.1.12.
6.1.13 Compliance
Perform the test in accordance with the method that is specified in 8.10 of YY 0500-2004; the result shall meet the requirements of 5.1.13.
Note: If the length of the bio-derived product does not meet the requirement of 10 times the diameter, record the test length in the result.
6.1.14 Connection strength
Perform the test in accordance with the method that is specified by the manufacturer; the result shall meet the requirements of 5.1.14.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test 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
- GB/T 16886.12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB 12279
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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 14233.2-2005 — 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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