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Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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Standard ID | YY 0053-2016 (YY0053-2016) | Description (Translated English) | Hemodialysis and relevant therapies. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C45 | Classification of International Standard | 11.040.30 | Word Count Estimation | 18,195 | Date of Issue | 3/23/2016 | Date of Implementation | 2018-01-01 | Older Standard (superseded by this standard) | YY 0053-2008 | Quoted Standard | GB/T 1962.2; GB/T 14233.1-2008; GB/T 16886.1; �л�����ҩ�� 2010��� | Adopted Standard | ISO 8637-2010, MOD | Drafting Organization | Weihai high blood purification Products Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Standardization Technical Committee for Extracorporeal Circulation Equipment (SAC/TC 158) | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Standard ID | YY 0053-2008 (YY0053-2008) | Description (Translated English) | Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C45 | Classification of International Standard | 11.040.30 | Word Count Estimation | 15,196 | Date of Issue | 2008-04-25 | Date of Implementation | 2009-12-01 | Older Standard (superseded by this standard) | YY 0053-1991 | Quoted Standard | GB/T 1962.2-2001; GB/T 2828.1; GB/T 14233.1; GB/T 14437-1997; GB/T 16886.1-2001; GB/T 16886.4-2003; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005; GB/T 16886.11-1997; YY 0267-2008; YY 0466-2003 | Adopted Standard | ISO 8637-2004, MOD | Drafting Organization | Guangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Technical Committee of Standardization for medical pump device | Regulation (derived from) | SFDA [2008] No. 192 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | China Food and Drug Administration | Summary | This standard specifies the use of the body's blood dialyzers, hemodialysis filtration device, hemofiltration, and hemoconcentrators technical requirements. Covered in this article of the "device" refers specifically to these products. This standard does not apply to: extracorporeal blood lines, plasma separator, blood perfusion apparatus, vascular access device, blood pump, extracorporeal blood tubing pressure monitor, air monitors, preparation, dialysate supply and monitoring system, used for hemodialysis, hemofiltration or hemodiafiltration system, further processing steps and equipment. | Standard ID | YY 0053-1991 (YY0053-1991) | Description (Translated English) | Hollow fiber dialyzer | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C45 | Classification of International Standard | 11.04 | Word Count Estimation | 13,189 | Date of Issue | 1991/10/12 | Date of Implementation | 1992/7/1 | Drafting Organization | Shanghai Medical Devices Research Institute | Administrative Organization | State Administration of Medicine Guangzhou medical equipment standardization technology sub - centralized units | Proposing organization | State Administration of Medicine | Issuing agency(ies) | State Administration of Medicine |
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 make the water cycle for 4h
with the flow of 200mL/min. Take 50mL of circulating fluid, dilute to 1000mL for later-
use.
Take the same volume of laboratory water, prepare a blank control solution without the
sample.
4.7.2 Reducing substances (easy oxides)
It shall be performed as per the Method II in 5.2.2 of GB/T 14233.1-2008; it shall
conform to the provisions of 3.6.1.
4.7.3 Metal ions
4.7.3.1 The atomic absorption spectrophotometry is an arbitration method; it shall be
performed as per the provisions of 5.9.1 in GB/T 14233.1-2008; it shall conform to the
provisions of 3.6.2.1.
4.7.3.2 Colorimetric analysis method. it shall be performed as per the Method I in 5.6.1
of GB/T 14233.1-2008; it shall conform to the provisions of 3.6.2.2.
4.7.4 pH value
It shall be performed as per the Method I in 5.4.1 in GB/T 14233.1-2008; it shall
conform to the provisions of 3.6.3.
4.7.5 Evaporation residue
It shall be performed as per the provisions of GB/T 14233.1-2008; it shall conform to
the provisions of 3.6.4.
4.7.6 UV absorbance
It shall be performed within the wavelength range of 250nm~320nm specified in GB/T
14233.1-2008; it shall conform to the provisions of 3.6.5.
4.7.7 Ethylene oxide residue
If applicable, inspect as per the analysis method of ethylene oxide residue in GB/T
14233.1; it shall conform to the provisions of 3.6.6.
4.7.8 Valid period
After an accelerated or real-time shelf life (equivalent to the valid period), the product
is tested for sterility, non-pyrogen and medical adhesion; it shall conform to the
f) Sterilization method;
g) Valid period;
h) Instructions for single use or multiple use;
i) There shall be a text description of “please read the instruction manual before
use’;
j) If applicable, instructions for the requirements of the ultrafiltration control unit shall
be available.
NOTE. In summary, the symbols in YY/T 0466.1 can also be used.
5.3 Markings on the outer package
The outer package shall have at least the following information.
a) Name and address of the manufacturer;
b) Product name, the description of product catalog and quantity on the outer
package;
c) Product specification and model or manufacturer instrument identification code;
d) Production batch number;
e) Sterility and non-pyrogen declaration;
f) Warning and instructions regarding treatment and storage;
g) Valid period.
NOTE. In summary, the symbols in YY/T 0466.1 can also be used.
5.4 Instruction manual
The instruction manual shall provide at least the following information.
a) Name and address of the manufacturer;
b) Product name;
c) User guide.
1) A description of the supporting equipment in the user guide (if applicable)
provided by the manufacturer;
2) The connection position of the extracorporeal circulation blood line and the
......
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...
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