YY 1290-2016 PDF in English
YY 1290-2016 (YY1290-2016) PDF English
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Single use bilirubin plasma hemoperfutor
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Standards related to (historical): YY 1290-2016
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YY 1290-2016: PDF in English YY 1290-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 45
Single use bilirubin plasma hemoperfutor
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and definitions ... 5
4 Classification ... 5
5 Requirements ... 5
6 Test methods ... 7
7 Inspection rules ... 9
8 Marking and operation instructions ... 10
9 Packaging, transportation and storage ... 11
Annex A (Normative) Bilirubin absorption performance test for hemoperfutor
... 13
Foreword
All technical content of this Standard is compulsory.
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuer of this document shall not be held
responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of Technical Committee 158 on Medical
Extracorporeal Circulation Equipment of Standardization Administration of China
(SAC/TC 158).
The drafting organizations of this Standard. China Food and Drug Administration
Guangdong Medical Devices Quality Surveillance and Test Centre, Jafron Biomedical
Co., Ltd., Tianjin Zibo High Technology Co., Ltd., Langfang Aier Hemopurification
Equipment Factory, Asahi Kasei Medical (HangZhou) Co., Ltd.
The main drafters of this Standard. Wu Jingbiao, He Xiaofan, Wang Peilian, Zhang
Guanghai, Li Tao, Guo Jianqin, Tianning.
Single use bilirubin plasma hemoperfutor
1 Scope
This Standard specifies the terms and definitions, classification, requirements, test
methods, inspection rules, marking and operation instructions, packaging,
transportation and storage for single use bilirubin hemoperfutor (hereinafter referred to
as hemoperfutor).
This Standard applies to single use bilirubin hemoperfutor. The hemoperfutor uses
plasma separator and hemopurification system to take the blood of hyperbilirubinemia
patients out of their body; the plasma is separated through the plasma separator; and
then plasma absorption is conducted to lower the level of bilirubin in plasma.
2 Normative References
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to This Standard.
GB/T 191, Packaging – Pictorial marking for handling of goods
GB/T 13074, Terms of blood purification
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
GB/T 16886.4, Biological evaluation of medical devices - Part 4. Selection of tests
for interactions with blood
GB/T 16886.5, Biological evaluation of medical devices - Part 5. Test for in vitro
cytotoxicity
GB/T 16886.10, Biological evaluation of medical devices - Part 10. Tests for irritation
and delayed-type hypersensitivity
Carry out test as specified in 6.7. The absorption capacity of hemoperfutor for bilirubin
shall be within the range specified by the manufacturer and shall not be lower than 0.8
μmol/mL resin.
5.10 Total protein absorption rate
The total protein absorption rate of hemoperfutor’s absorbent shall be as specified by
the manufacturer. The absorption rate shall be < 15%.
5.11 Temperature resistance
Hemoperfutor shall have no deformation or cracking within the range 0°C ~ 50°C.
6 Test methods
6.1 Appearance
Use normal or corrected visual acuity to observe and observe under average
illumination of 300 lx ~ 750 lx without amplification. It shall be as specified in 5.1.
6.2 Capacity of blood chamber
Use water to fill the blood chamber in laboratory, avoiding air bubble entrainment; place
aside for 60 min; use pressurized air (about 50 kPa) to drain the water in the blood
chamber; and use a general measuring tool to measure. It shall be as specified in 5.2.
6.3 Particle shedding
Carry out test as specified in Annex A to YY 0464-2009. It shall be as specified in 5.3.
6.4 Chemical property
6.4.1 Test solution preparation
Take one sterilized hemoperfutor and one glass flask to form a closed cycle system;
use 500 mL of normal saline to lavage and soak the hemoperfutor from bottom to top;
add up to 250 mL of normal saline in the glass flask after bubble disappears; maintain
temperature at 37°C ± 1°C; use a peristaltic pump to act on a section of silicone tube
as short as possible to make the circulating solution to circulate for 2 h at the flow rate
of 1 L/h; take 50 mL of circulating solution; and use normal saline to dilute to 1 000 mL
as standby.
Take the same volume of normal saline and use the same method to make blank
control solution without loading sample.
6.4.2 Reducing substance (readily oxidizable substance)
6.5.5.2 Complement activation test
Carry out test as specified in GB/T 16886.4. There shall be no significant difference in
statistics between the result and the negative control.
6.6 Sterility
Carry out sterility test using the test method specified in GB/T 14233.2-2005. The result
shall be as specified in 5.6.
6.7 No heat source
Carry out heat source test using the test method specified in GB/T 14233.2-2005. The
result shall be as specified in 5.7.
6.8 Sealability
Use pressurized air (about 50 kPa) to empty hemoperfutor; seal one end of
hemoperfutor; apply air pressure 100 kPa at the other end; soak into water at 23°C ±
2°C; and observe for 10 min. There shall be no air bubble generated.
A proved equivalent method can also be used to test sealability.
6.9 Absorption property of hemoperfutor for bilirubin
Registered diagnostic kits and relevant methods can be used to test absorption
property.
Carry out test using the method specified in Annex A. The result shall be as specified
in 5.9.
6.10 Total protein absorption rate
Registered diagnostic kits and relevant methods can be used to test absorption
property.
Carry out test using the method specified in Annex A. The result shall be as specified
in 5.10.
6.11 Temperature resistance
Place hemoperfutor in a refrigerator for 30 min at 0°C; then place in an incubator for 3
h at 50°C; take out to recover to room temperature before observing; and carry out test
as specified in 6.6. It shall be as specified in 5.11.
7 Inspection rules
Inspection rules shall be specified by the manufacturer.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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