YY/T 1758-2020 English PDF (YYT1758-2020)

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YY/T 1758-2020: Cardiovascular implants -- Pulmonary valve conduit
YY/T 1758-2020
YY
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 Contents
Foreword ... 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 conduit
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 2.0×108 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 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.
6.2 Chemical test
6.2.1 Preparation of test solution