YY/T 1758-2020 PDF EnglishUS$170.00 · In stock · Download in 9 seconds
YY/T 1758-2020: Cardiovascular implants - Pulmonary valve conduit Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1758-2020: Cardiovascular implants - Pulmonary valve conduit---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1758-2020YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 30 Cardiovascular implants - Pulmonary valve conduit 心血管植入物 肺动脉带瓣管道 ISSUED ON: SEPTEMBER 27, 2020 IMPLEMENTED ON: SEPTEMBER 01, 2021 Issued by: National Medical Products Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions ... 5 4 Raw material ... 5 5 Requirements ... 6 6 Test method ... 8 7 Packaging, marking, transportation and storage ... 12 Cardiovascular implants - Pulmonary valve conduit1 ScopeThis 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 referencesThe 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 prostheses5 Requirements5.1 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 2.0×108 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 method6.1 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. 6.2 Chemical test 6.2.1 Preparation of test solution ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 1758-2020 be delivered?Answer: The full copy PDF of English version of YY/T 1758-2020 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 1758-2020_English with my colleagues?Answer: Yes. 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