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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 | 6,638 |
| 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
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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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