YY 0053-2008 PDF in English
YY 0053-2008 (YY0053-2008) PDF English
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Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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Newer version: YY 0053-2016 Standards related to: YY 0053-2016
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YY 0053-2008: PDF in English YY 0053-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 45
Replacing YY 0053-1991
Cardiovascular implants and artificial organs -
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
(ISO 8637.2004, MOD)
ISSUED ON. APRIL 25, 2008
IMPLEMENTED ON. DECEMBER 1, 2009
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Requirements ... 6
4 Test methods ... 9
5 Marks ... 17
Appendix A ... 22
Appendix B ... 23
Foreword
All technical contents of this Standard are mandatory.
This Standard modifies and adopts ISO 8637.2004 “Cardiovascular implants
and artificial organs - Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators”.
This Standard replaces YY 0053-1991 “Hollow-fiber dialyzer”.
Differences between this Standard and YY 0053-1991.
- Add haemodiafilters, haemofilters, and haemoconcentrators according to
the application scope of international standards, so as to broaden the
application scope of this Standard;
- Add project indicators for multiple use of haemodialysers according to
relevant content of international standards, so as to make this Standard
not to be limited to the range of single use;
- Add biological evaluation to conduct inspection by use of prevailing
domestic methods and projects according to the content of the relevant
international standards and national regulations, so as to suit Chinese
national conditions;
- In use performance, modify the decline rate of creatinine and urea TO the
clearance-rate of creatinine, urea, vitamin B12 and phosphate; add
inspection items for screening factors of haemodiafilters, haemofilters and
haemoconcentrators; specify the screening factors for albumin, myoglobin
and inulin;
- Provide multiple test plans in test methods for the user.
Appendix A and Appendix B of this Standard are informative.
This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee
of Standardization for Medical Cardiopulmonary Bypass Equipment.
The drafting organization of this Standard. Guangdong Medical Devices Quality
Surveillance and Test Institute of State Food and Drug Administration.
Main drafters of this Standard. He Xiaofan, Wu Jingbiao and Zhou Ying.
Cardiovascular implants and artificial organs -
Haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators
1 Scope
This Standard specifies the technical requirements for haemodialysers,
haemodiafilters, haemofilters and haemoconcentrators, which are used in
human body. “Devices” in this Standard refer to these products.
This Standard is not applicable to.
- Extracorporeal blood line;
- Plasma separator;
- Blood perfusion apparatus;
- Vascular access device;
- Blood pump;
- Pressure monitor of extracorporeal blood line;
- Air monitor;
- Dialysate preparation, supply and monitoring system;
- System used for hemodialysis, hemofiltration or hemodiafiltration;
- Further processing steps and equipment.
Note. Requirements for extracorporeal blood lines of haemodialysers, haemodiafilters
and haemofilters shall comply with provisions in YY 0267.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 1962.2-2001 Conical fittings with a 6% (Luer) taper for syringes,
needles and certain other medical equipment - Part 2. Lock fittings (GB/T
1962.2-2001, ISO 594-2.1998, IDT)
GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1.
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection (GB/T 2828.1-2003, ISO 2859-1.1999, IDT)
GB/T 14233.1 Test methods for infusion transfusion injection equipment for
medical use - Part 1. Chemical analysis methods
GB/T 14437-1997 Single sampling procedures and tables by attributes
(suitable for large amount)
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1.
Evaluation and testing within a risk management process (idt ISO 10993-
1.1997)
GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4.
Selection of tests for interactions with blood (ISO 10993-4.2002, IDT)
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test
for in vitro cytotoxicity (ISO 10993-5.1999, IDT)
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7.
Ethylene oxide sterilization residuals (idt ISO 10993-5.1995)
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10.
Tests for irritation and delayed-type hypersensitivity (ISO 10993-10.2002,
IDT)
GB/T 16886.11-1997 Biological evaluation of medical devices - Part 11. Tests
for systemic toxicity (idt ISO 10993-11.1993)
YY 0267-2008 Cardiovascular implants and artificial organs - Extracorporeal
blood circuit for blood purification devices
YY 0466-2003 Medical devices - Symbols to be used with medical device
labels labelling and information to be supplied (YY 0466-2003, ISO
15223.2000, IDT)
The Pharmacopoeia of the People's Republic of China
solution, collected air, and equipment pollution caused by impurities, algae and
bacteria.
4.2 Biological evaluation
Conduct biological evaluation on the part which is directly or indirectly in contact
with patient’s blood of haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators according to provisions in GB/T 16886.1, GB/T 16886.4,
GB/T 16886.5, GB/T 16886.10 and GB/T 16886.11.
4.2.1 Residual ethylene oxide
Conduct inspection according to the analysis method of residual ethylene oxide
in GB/T 14233.1; it shall be ≤ 10 mg/kg.
4.3 Sterility
4.3.1 Conduct according to the provisions in Pharmacopoeia of People's
Republic of China and provisions in 3.2.
Note. This method is not suitable for exit-factory inspection.
4.3.2 Appropriate sterilization methods are shown in Appendix B.
4.4 Pyrogen free
Evaluate the pyrogenicity of haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators by appropriate test methods. Inspect according to the
provisions in Pharmacopoeia of People's Republic of China and provisions in
3.3.
4.5 Mechanical performance
4.5.1 Structure adhesion
4.5.1.1 General principles
Conduct according to the following test methods and requirements in 3.4.1.
4.5.1.2 Positive pressure test
Fill the device with degassed distilled water. Place it at 37°C ± 1°C. Except the
interfaces with pressure test equipment, all the interfaces shall be closed. Apply
a positive pressure which is 1.5 times stipulated pressure by the manufacturer
to the product, and close the test equipment. After 10 min, record the pressure
value and visually check whether the product has leakage.
4.5.1.3 Negative pressure test
Figure 5 Device schematic diagram of ultrafiltration rate or screening factor
measurement of coil-type or hollow fiber haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators
4.6.4 Blood chamber capability
For hollow-fiber dialyzer, calculate chamber volume according to dialyzer size
and the number of fiber bundles. If there are significant changes in the size of
the known film after contacting with the solution, it shall use the following test
methods.
As another choice, use a solution that is easy to be extracted but does not go
through the film to fill the blood chamber. Measure solution volume fulfilled in
the blood chamber. Measure under the given scope of transmembrane
pressure. If there is no change in blood chamber volume, it shall be acceptable
to inspect under one single pressure.
4.6.5 Pressure drop
4.6.5.1 Pressure drop of blood chamber
4.6.5.1.1 General principles
Conduct inspection according to the following test methods and requirements
in 3.5.5.1.
4.6.5.1.2 Test solution
Use anticoagulated bovine plasma of which the protein concentration is 60 g/L
± 5 g/L as test solution or solution of similar viscosity to fill the blood chamber.
Use general dialysate to fill dialysate chamber or filtrate chamber.
4.6.5.1.3 Test steps
Adjust blood flow rate, read pressure value of blood chamber entrance, and
calculate pressure drop. Repeat the inspection according to the scope of blood
flow rate provided by the manufacturer.
For flat-plate dialyzer, adjust dialysate flow rate. And it is necessary to detect
pressure and blood flow rate.
4.6.5.2 Pressure drop of dialysate compartment
4.6.5.2.1 Test solution
Use general dialysate as test solution to fill the dialysate compartment.
Use bovine plasma to fill th...
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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