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YY/T 1564-2017 English PDF

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YY/T 1564-2017: Cardiovascular implants - Pulmonary valve conduit - Pulsatile flow test methods
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1564-2017119 Add to Cart 3 days Cardiovascular implants - Pulmonary valve conduit - Pulsatile flow test methods Valid

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Basic data

Standard ID: YY/T 1564-2017 (YY/T1564-2017)
Description (Translated English): Cardiovascular implants - Pulmonary valve conduit - Pulsatile flow test methods
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 6,666
Date of Issue: 2017-03-28
Date of Implementation: 2018-04-01
Issuing agency(ies): State Food and Drug Administration

YY/T 1564-2017: Cardiovascular implants - Pulmonary valve conduit - Pulsatile flow test methods

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Cardiovascular implants-Pulmonary valve conduit-Pulsatile flow test methods ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Cardiovascular implants Pulmonary artery valves In vitro pulsatile flow test method 2017-03-28 Posted 2018-04-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Surgical implants and orthopedic instruments Standardization Technical Committee of cardiovascular implants sub-technical committee (SAC / TC110/SC2) centralized. This standard drafting unit. China Food and Drug Control Research Institute, Beijing Bai Ren Medical Technology Co., Ltd.. The main drafters of this standard. Liu Li, Tang Jing Long, Wang Shuo, Wang Ying, Shang Ruyao, Wan Chen Jie, Li Chong Chong, Wu Jia, Jin Lei, Shao Anliang, Feng Xiaoming, Wang Chunren. Cardiovascular implants Pulmonary artery valves In vitro pulsatile flow test method

1 Scope

This standard specifies the valve with pulsating flow in vitro performance testing methods. This standard applies to flasks in vitro pulsatile flow test.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 12279 Cardiovascular implants Artificial heart valves (ISO 5840.1996, IDT) ISO 5840-3-2013 Cardiovascular implants Artificial heart valves - Part 3. Catheter-implanted prosthetic heart valves (Cardi- ovascularimplants-Cardiacvalve prostheses-Part 3. Heartvalvesubstitutesimplantedbytran- scathetertechniques)

3 Terms and definitions

Terms and definitions defined in GB 12279 and ISO 5840-3.2013 apply to this document.

4 test methods

4.1 test system 4.1.1 in vitro pulsatile flow test system should be able to produce similar physiological conditions pulsation, the physiological conditions should be consistent with Table 1, Table 2 Claim. 4.1.2 In vitro pulsatile flow performance test The performance of the system can be confirmed by reference to the valve. 4.1.3 In vitro pulsatile flow performance test system should be able to test the pressure over time, the volume flow rate, velocity field and turbulent shear stress field. 4.1.4 In vitro pulsatile flow performance test system repeatability should be evaluated. 4.1.5 in vitro pulsatile flow test system geometry and mechanical properties should be able to represent the expected site of implantation. 4.1.6 Testers should be able to observe and photograph blood inflow and outflow during all phases of circulation. 4.1.7 The pressure measurement system shall have a natural frequency of at least 50 times the test cycle rate and a measurement accuracy of ± 0.26 kPa (± 2 mmHg) Range. 4.1.8 Flow measurement system measurement accuracy should be within ± 2mL range. 4.1.9 The minimum measurement accuracy of all other measuring equipment shall be within ± 5% of the full scale reading. 4.2 test conditions According to the population of pulmonary artery valves, select the appropriate test conditions in Table 1 and Table 2.
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