YY/T 1758-2020 English PDF (YY/T1758-2020)

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YY/T 1758-2020: Cardiovascular implants - Pulmonary valve conduit
YY/T 1758-2020
Cardiovascular implants - Pulmonary valve conduit
People's Republic of China Pharmaceutical Industry Standards
Released on 2020-09-27
Implementation of 2021-09-01
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Raw materials 2
5 Requirements 2
6 Test method 4
7 Packaging, marking, transportation and storage 6
Preface
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the Cardiovascular Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/
TC110/SC2) centralized.
Drafting organizations of this standard. China Institute of Food and Drug Control, Beijing Bairen Medical Technology Co., Ltd.
The main drafters of this standard. Liu Li, Tang Jinglong, Ke Linnan, Han Qianqian, Wu Jia, Jin Lei, Shao Anliang, Feng Xiaoming, Wang Chunren.
Cardiovascular implant pulmonary valved catheter
1 Scope
This standard specifies the basic requirements for valved pulmonary ducts.
This standard applies to the correction or reconstruction of the valved pulmonary duct of the right ventricular outflow tract.
This standard does not apply to prostheses derived from allogeneic and autologous tissues (autologous transplantation).
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 article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 191 Graphical signs for packaging, storage and transportation
GB/T 9969 General Rules for Use of Industrial Products
GB 12279 Cardiovascular implants and artificial heart valves
GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods
GB/T 14233.2-2005 Medical transfusion, blood transfusion, 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 16886.12 Biological Evaluation of Medical Devices Part 12.Sample Preparation and Reference Samples
YY/T 0313 Medical polymer product packaging and information provided by the manufacturer
YY/T 04666.1 Medical devices used for medical device labeling, marking and information symbols. Part 1.General requirements
YY 0500-2004 Cardiovascular implants and artificial blood vessels
YY/T 0771.1 Animal tissues and derivatives used in the manufacture of medical devices Part 1.Risk analysis and management
YY/T 07771.2 Animal tissues and derivatives used in the manufacture of medical devices Part 2.Source, collection and handling control
YY/T 07771.3 Animal tissues and derivatives used in the manufacture of medical devices Part 3.Removal and removal of viruses and infectious agents
(Or) Confirmation of inactivation
YY/T 14493-2016 Cardiovascular implants, artificial heart valves, part 3 transcatheter implantable artificial heart valves
(ISO 5840-3.2013, IDT)
YY/T 1564-2017 Cardiovascular implants pulmonary artery valved pipeline in vitro pulsating flow performance test method
Four editions of the.2015 edition of the Pharmacopoeia of the People's Republic of China
3 Terms and definitions
The following terms and definitions defined in GB 12279, YY 0500-2004 and YY/T 1449.3-2016 apply to this document.
3.1
Vascular prosthesis with valve structure is used for replacement, repair and reconstruction of the human cardiovascular system.
3.2
A valved tube dedicated to the human pulmonary artery.
4 Raw materials
The composition of the product and the source of each part of the raw material should be clarified. Among them, animal-derived materials should comply with YY/T 0771.1, YY/T 0771.2,
The requirements of YY/T 0771.3.At the same time, it is necessary to clarify the species of the supplier animal, the type and location of the biological tissue as the source of the material.
5 requirements
5.1 Physical properties
5.1.1 Appearance
The valved pulmonary pipeline should be well-defined and complete, and the surface should be clean and free of defects, spots, and other defects that affect its use.
5.1.2 Specifications
The inner diameter and length of the valved pulmonary tube should meet the manufacturer's specifications.
5.1.3 External durability
In vitro accelerated fatigue test 2.0×108 cycles to evaluate the performance of in vitro pulsating flow, and the results should meet the manufacturer's specifications. Valve leaflet
There should be no damage.
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 valved pulmonary pipeline should meet the manufacturer's specifications.
5.1.4.2 Steady state leakage test
The steady-state leakage test results of valved pulmonary pipelines should meet the manufacturer's specifications.
5.1.4.3 Pulsating flow test
The pulsating flow test results of valved pulmonary ducts should meet the manufacturer's specifications.
5.1.5 Valve opening and closing state
The valve leaflets of the valved pulmonary artery should be opened and closed completely.
5.1.6 Expanded inner diameter
Under the pressure of 8kPa (60mmHg), the expanded inner diameter of the valve of the pulmonary artery valved pipeline should meet the manufacturer's regulations.
5.1.7 Tensile strength of pipe
5.1.7.1 Tensile strength in circumferential direction
The circumferential tensile strength of the pulmonary valved pipeline should meet the manufacturer's specifications.
5.1.7.2 Axial tensile strength
The axial tensile strength of the valved pulmonary tube should meet the manufacturer's specifications.
5.1.8 Pipeline blasting strength
The burst strength of the valved pulmonary pipeline should meet the manufacturer's regulations.
5.1.9 Pulling strength of pipeline
The pulling strength of the pulmonary valved pipeline should meet the manufacturer's regulations.
5.1.10 Pipeline water permeability
The water permeability of valved pulmonary pipelines should meet the manufacturer's specifications.
5.1.11 Wall thickness
The wall thickness of the valved pulmonary artery should meet the manufacturer's regulations.
5.1.12 Kink diameter
The kinking diameter of pulmonary valved tubing should meet the manufacturer's specifications.
5.1.13 Compliance
The compliance of the pulmonary valved pipeline should meet the manufacturer's regulations.
5.1.14 Connection strength
The strength of the connection between the different components of the pulmonary valved pipeline should be considered, and the manufacturer's specifications should be met.
5.2 Chemical properties
5.2.1 pH
The test solution is compared with the blank solution of the same batch, and the difference in pH value should not exceed 1.5.
5.2.2 Heavy metals
The total content of heavy metals in the test solution should not exceed 1μg/mL.
5.2.3 Residues
Manufacturers should 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 should be evaluated.
5.3 Biological performance
5.3.1 Sterile
The valved pulmonary tube should be sterile.
5.3.2 Bacterial endotoxin
The bacterial endotoxin of the valved pulmonary duct should be less than 2.15 EU/piece.
5.3.3 Pyrogen
Pulmonary valved tubing should not cause pyrogen reactions.
5.3.4 Calcification
The pulmonary artery valved tube was implanted subcutaneously for 8 weeks, and the calcium content should not be higher than the reference substance.
5.3.5 Biocompatibility
The pulmonary valved pipeline should be biologically evaluated in accordance with GB/T 168886.1.
6 Test method
6.1 Physical test
6.1.1 Appearance
Visual observation, the results should meet the requirements of 5.1.1.
6.1.2 Specifications
Carry out the test in accordance with the methods specified in 8.4 and 8.5 of YY 0500-2004, and the results should meet the requirements of 5.1.2.
6.1.3 External durability
Carry out the durability test according to the method in YY/T 14493-2016.After the test, perform the performance of the external pulsating flow in accordance with 6.1.4.3
Carry out the test, and the result should meet the requirements of 5.1.3.
Visual observation should meet the requirements of 5.1.3.
6.1.4 Fluid dynamics
6.1.4.1 Steady-state forward flow test
According to the method specified in GB 12279, the result should meet the requirements of 5.1.4.1.
6.1.4.2 Steady state leakage test
According to the method specified in GB 12279, the result should meet the requirements of 5.1.4.2.
6.1.4.3 Pulsating flow test
According to the method specified in GB 12279 and YY/T 1564-2017, the result should meet the requirements of 5.1.4.3.
6.1.5 Valve opening and closing state
Under the conditions of the pulsating flow test, the opening and closing state of the valve is recorded by imaging, and the results should meet the requirements of 5.1.5.
6.1.6 Expanded inner diameter
Carry out the test in accordance with the method specified in 8.6 of YY 0500-2004, the test pressure is 8kPa (60mmHg), and the result should meet
5.1.6 Provisions.
6.1.7 Tensile strength of pipe
6.1.7.1 Tensile strength in circumferential direction
Carry out the test in accordance with the method specified in 8.3.1 of YY 0500-2004, and the results should meet the requirements of 5.1.7.1.
6.1.7.2 Axial tensile strength
Carry out the test in accordance with the method specified in 8.3.2 of YY 0500-2004, and the results should meet the requirements of 5.1.7.2.
6.1.8 Pipeline blasting strength
Carry out the test in accordance with the method specified in 8.3.3 of YY 0500-2004, and the results should meet the requirements of 5.1.8.
6.1.9 Pulling strength of pipeline
Carry out the test in accordance with the method specified in 8.8 in YY 0500-2004, and the results should meet the requirements of 5.1.9.
6.1.10 Pipeline water permeability
Carry out the test in accordance with the method specified in 8.2 of YY 0500-2004, and the results should meet the requirements of 5.1.10.
6.1.11 Wall thickness
Carry out the test in accordance with the method specified in 8.7 of YY 0500-2004, and the results should meet the requirements of 5.1.11.
6.1.12 Kink diameter
Carry out the test in accordance with the method specified in 8.9 of YY 0500-2004, and the results should meet the requirements of 5.1.12.
6.1.13 Compliance
Carry out the test in accordance with the method specified in 8.10 of YY 0500-2004, and the results should 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
Carry out the test in accordance with the method specified by the manufacturer, and the results should meet the requirements of 5.1.14.
6.2 Chemical test
6.2.1 Preparation of test solution
Prepare the test solution in accordance with the method of GB/T 16886.12.Weigh the product and add distilled water at the ratio of 0.2g sample to 1mL,
Under the condition of (37±1)℃, extract for 72h to prepare the extract.
6.2.2 pH
The test was carried out in accordance with the method of 5.4.1 in GB/T 14233.1-2008, and the results...