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YY 0053-2016: Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY 0053-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 45
Replacing YY 0053-2008
Hemodialysis and Relevant Therapies -
Haemodialysers, Haemodiafilters,
Haemofilters and Haemoconcentrators
(ISO 8637.2010, MOD)
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements ... 5
4 Test Methods ... 9
5 Marking ... 19
Appendix A (Informative) Technical Differences and Causes between this
Standard and ISO 8637.2010 ... 23
Bibliography ... 24
Hemodialysis and Relevant Therapies -
Haemodialysers, Haemodiafilters,
Haemofilters and Haemoconcentrators
1 Scope
This Standard specifies the technical requirements for haemodialysers,
haemodiafilters, haemofilters and haemoconcenrators used for human body; the
“instruments” involved in this document indicate the above-mentioned products.
This Standard is not applicable to.
--- Extracorporeal circulation blood line;
--- Plasma separator;
--- Blood perfusion device;
--- Vascular access device;
-- Blood pump;
--- Pressure monitor of the extracorporeal circulation blood line;
--- Air monitor;
--- System for preparing, supplying and monitoring dialysate;
--- System for performing hemodialysis, hemofiltration or hemodiafiltration treatment;
--- Retreatment steps and equipment.
NOTE. The requirements for extracorporeal circulation blood line of haemodialysers,
haemodiafilters and haemofilters are specified in YY 0267-2016.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
The screening coefficients of albumin, inulin and myoglobin or β2-microglobulin shall
conform to the provisions of the manufacturer. The test conditions shall be subject to
the information given by the manufacturer.
3.5.3 Ultrafiltration rate
The ultrafiltration rate shall conform to the provisions of the manufacturer. The test
shall cover the range of transmembrane pressure and blood flow rate specified by the
manufacturer.
3.5.4 Blood chamber volume
The blood chamber volume shall conform to the provisions of the manufacturer; the
test conditions shall cover the range of transmembrane pressure specified by the
manufacturer.
If the blood chamber is not compliant, it is confirmed that the volume under any
particular transmembrane pressure is acceptable.
3.5.5 Blood chamber pressure drop
The blood chamber pressure drop shall conform to the provisions of the manufacturer.
3.6 Chemical properties
3.6.1 Reducing substances (easy oxides)
The volume difference of potassium permanganate solution [c(KMnO4=0.002mol/L)]
consumed by 20mL test solution and the same batch of blank solution shall not exceed
2.0mL.
3.6.2 Metal ions
3.6.2.1 When using the atomic absorption spectrophotometer (AAS) or equivalent
method to test, the total content of the antimony, chromium, copper, lead and tin in the
test solution shall not exceed 1µg/mL. The cadmium content shall not exceed
0.1µg/mL.
3.6.2.2 Colorimetric analysis method. the color of the test solution shall not exceed the
standard control solution with mass concentration of ρ(Pb2+) = 1µg/mL.
3.6.3 pH value
The pH value difference between test solution and the same batch of blank solution
shall not exceed 1.5.
3.6.4 Evaporation residue
The part of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
that is in direct or indirect contact with the patient’s blood shall be biologically evaluated
according to the provisions of GB/T 16886.1.
4.3 Sterility
4.3.1 It shall be performed according to the PRC pharmacopoeia, and shall conform to
the provisions of 3.2.
NOTE. such method is not suitable for exit-factory inspection.
4.3.2 Refer to the relevant standards for the suitable sterilization methods.
4.4 Non-pyrogen
Appropriate test methods shall be selected to evaluate the pyrogenicity of
haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The test shall
be performed as per the PRC pharmacopoeia, and shall conform to the provisions of
3.3.
4.5 Mechanical properties
4.5.1 Mechanical adhesion
4.5.1.1 General
Test shall be performed as per 4.5.1.2~4.5.1.3, and shall meet the requirements of
3.4.1.
4.5.1.2 Positive pressure test
Fill the instrument with degassed distilled water; place at 37°C±1°C; all interfaces shall
be closed except the interface connecting to the pressure test device. Exert a positive
pressure of 1.5 times of the pressure specified by the manufacturer, and close the test
device. After 10min, record the pressure value and visually examine whether the
product has leakage.
4.5.1.3 Negative pressure test
Fill the instrument with degassed distilled water; place at 37°C±1°C; all interfaces shall
be closed except the interface connecting to the pressure test device. Exert a negative
pressure of 1.5 times of the pressure specified by the manufacturer; unless the
negative pressure exceeds 93.3kPa (700mmHg) or is not specified; at this time,
93.3kPa (700mmHg) negative pressure shall be exerted; close the test device. The
obtainable maximum negative pressure value shall be exerted in the high-altitude area;
after 10min, record the pressure value and visually examine whether the product has
leakage.
10 – measure the pressure value on the outlet side of dialysate pDO.
Figure 4 – Schematic Diagram of an Open-Loop Device for Determining the
Clearance Rate of Haemodialysers and haemodiafilters
4.6.2.4 Calculation formula of screening coefficient
Where.
S – screening coefficient;
cBI – solution concentration on the blood inlet of haemodiafilters, haemofilters and
haemoconcentrators;
cBO - solution concentration on the blood outlet of haemodiafilters, haemofilters and
haemoconcentrators;
cF – solution concentration on the filtrate end of haemodiafilters, haemofilters and
haemoconcentrators.
In Formula (2), cBI, cBO and cF are in the same concentration unit.
4.6.3 Ultrafiltration rate
4.6.3.1 Test solution
The test solution of haemodialysers, haemodiafilters and haemofilters shall be
anticoagulated bovine blood or human blood with protein concentration of 60g/L±5g/L,
and the hematocrit of 32%±3%. Or the fresh anticoagulated bovine plasma with protein
concentration of 60g/L±5g/L; while the test solution of haemoconcentrators can use
the anticoagulated bovine blood or human blood with protein concentration of
50g/L±5g/L, and hematocrit of 25%±3%.
No solution shall be used to perfuse the dialysate space or filtrate chamber.
4.6.3.2 Test procedures
Assemble the test circuit as per Figure 5. Adjust the flow rate of blood and filtrate to be
stable (including temperature, flow rate and pressure). Measure the size of the
ultrafiltration rate, so that cover the range given by the manufacturer. Measure the
ultrafiltration rate value as per the transmembrane pressure sequence from small to
large.
Take a set of samples to form a circulation system through connecting with a glass
flask; add 500mL of laboratory water and keep it at 37°C±1°C; apply a peristatic pump
to a section of silicone rubber tube as short as possible to m...