YY/T 1566.1-2017 English PDF (YYT1566.1-2017)

This part of YY/T 1566 specifies the requirements for the centrifuge bowl type blood cell recovery set used in surgical operations. It is a single-use product to ensure the safety of use with autologous blood recovery device. This part applies to centrifuge bowl type blood cell recovery set that are intended to be used in conjunction with other autologous blood processing devices during surgery, and are expected to be used in conjunction with autologous blood recovery device. It consists of a tube system, a separation bowl, a red blood cell collection bag, and a waste solution bag. It does not include a blood collection filter (reservoir).

YY/T 1566.1-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Autologous blood processing devices for single use -
Part 1. Blood cell recovery sets, centrifuge bowl type
ISSUED ON. JULY 17, 2017
IMPLEMENTED ON. JULY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 4
Introduction .. 5
1 Scope .. 6
2 Normative references . 6
3 Terms and definitions . 7
4 Structure . 9
5 Physical requirements . 9
5.1 Appearance . 9
5.2 Particle contamination . 10
5.2.1 Separation bowl . 10
5.2.2 Pipeline system . 10
5.2.3 Red blood cell collection bag . 10
5.3 Sealing . 10
5.4 Connection strength . 11
5.5 Frictional heat .. 11
5.6 Noise . 11
5.7 Residual amount . 11
5.8 Color scale . 12
5.9 Piercer . 12
5.10 Drip bucket .. 12
5.11 Flow regulator . 12
5.12 Pump tube) elasticity . 12
5.13 Position limit clip) (if any) . 12
5.14 Fixture .. 13
5.15 Interface . 13
5.16 Protective sleeve . 13
5.17 Red blood cell collection bag . 13
6 Chemical requirements . 13
6.1 Separation bowl and pipeline system .. 13
6.1.1 Reducing substances . 13
6.1.2 Metal ions .. 14
6.1.3 pH . 14
6.1.4 Evaporation residue .. 14
6.1.5 UV absorbance . 14
6.2 Red blood cell collection bag .. 14
6.3 Ethylene oxide residues .. 14
7 Biological requirements . 15
7.1 Biological compatibility . 15
7.2 Sterile .. 15
7.3 Bacterial endotoxin .. 15
8 Type test. 15
9 Markings . 15
9.1 General .. 15
9.2 Single package marking .. 16
9.3 Shelf packaging marking . 16
10 Packaging . 17
Appendix A (Informative) Descriptions . 18
Appendix B (Normative) Physical test . 21
Appendix C (Normative) Chemical test . 25
References . 27
Autologous blood processing devices for single use -
Part 1. Blood cell recovery sets, centrifuge bowl type
1 Scope
This part of YY/T 1566 specifies the requirements for the centrifuge bowl type blood cell recovery set used in surgical operations. It is a single-use product to ensure the safety of use with autologous blood recovery device.
This part applies to centrifuge bowl type blood cell recovery set that are intended to be used in conjunction with other autologous blood processing devices during surgery, and are expected to be used in conjunction with autologous blood recovery device. It consists of a tube system, a separation bowl, a red blood cell collection bag, and a waste solution bag. It does not include a blood collection filter (reservoir).
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 amendments) are applicable to this standard.
GB/T 6682 Water for analytical laboratory use - Specification and test
methods
GB 8368 Infusion sets for single use, gravity feed
GB 14232.1-2004 Plastics collapsible containers for human blood and blood component - Part 1. Conventional containers
GB/T 14233.1-2008 Test methods for infusion reinfusion injection equipment for medical use - Part 1. Chemical analysis methods
GB/T 14233.2 Test methods for infusion, reinfusion, 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
5.1.5 The interface of the separation bowl, clamps, and other component surfaces shall be smooth and free from burrs.
5.2 Particle contamination
5.2.1 Separation bowl
When measured in accordance with B.1, the number of particles 15 μm ~ 25 μm in 200 mL eluent shall not exceed 6.00 particles/mL, particles greater than 25 μm shall not exceed 3.00 particles/mL.
5.2.2 Pipeline system
When measured in accordance with B.2, the number of particles 15 μm ~ 25 μm on the surface area per square centimeter shall not exceed 1.00, the number of particles larger than 25 μm shall not exceed 0.50.
5.2.3 Red blood cell collection bag
The production of red blood cell collection bags shall avoid particle
contamination.
When tested in accordance with the provisions of B.3, red blood cell collection bag shall have no visible particles.
Note. Work is under way to establish limits on the number and size of particles. The limits and test methods given in pharmacopoeias (such as the limits and methods of preparations specified in the European Pharmacopoeia) are
currently available.
5.3 Sealing
5.3.1 When the separation bowl is subject to particle contamination test in accordance with B.1, the separation bowl shall be free from leakage.
Note. The sealability of the separation bowl and the particle contamination test are combined.
5.3.2 SEAL the other ends of the pipelines in the pipeline system, LEAVE one end and LEAD in 50 kPa air pressure for 15 s. There shall be no continuous air bubble leakage in the underwater test.
6.1.2 Metal ions
When measured by atomic absorption spectrophotometry (AAS) or equivalent, the total content of antimony, chromium, copper, lead, and tin in the extract shall not exceed 1 μg/mL, the content of cadmium shall not exceed 0.1 μg/mL.
When tested in accordance with C.3, the color present in the extract shall not exceed the standard control solution with a mass concentration ρ(Pb2+) = 1 μg/mL.
6.1.3 pH
When tested in accordance with C.4, the difference between the pH of the test solution prepared in accordance with C.1.3 and the blank solution shall not exceed 1.5.
6.1.4 Evaporation residue
When tested in accordance with C.5, the total amount of evaporation residue in 50 mL of the test solution prepared in accordance with C.1.3 shall not exceed 2 mg.
6.1.5 UV absorbance
When tested in accordance with C.6, the absorbance of the test solution prepared in accordance with C.1.3 in the range of 250 nm ~ 320 nm shall not exceed 0.1.
6.2 Red blood cell collection bag
The test solution prepared in accordance with C.1.4 shall meet the
requirements of GB 14232.1-2004.
6.3 Ethylene oxide residues
If ethylene oxide is used for sterilization, when tested in accordance with Appendix C, the residual ethylene oxide residuals per set of centrifuge bowl type blood cell recovery set (excluding the waste solution bag) shall not exceed 4.0 mg.
Appendix A
(Informative)
Descriptions
A.1 Scope
Appendix A of ANSI/AAMI AT6.2013 “Autologous blood reinfusion devices”
describes the clinical application of autologous blood reinfusion as follows. Autologous blood reinfusion refers to the collection, storage, and reinfusion of blood products from the same patient. There are many cases where an
autologous blood reinfusion is ideally useful or life-saving, especially when allogeneic blood is not immediately available. These conditions include the following types of clinical autologous blood reinfusion.
a) Collection, storage and reinfusion during optional surgery or emergency during surgery;
b) Collection, storage and reinfusion in the event of a life-threatening injury or major blood loss.
All autologous blood reinfusion devices will have blood contact with the surrounding environment, so it will use anticoagulants, purification (filtration), washing and reinfusion. Therefore, all kinds of instruments used in these links have dangerous sources. These dangerous sources should be recognized by a standard. Due to the group of patients who use these devices, most reinfusion devices do not have an advantage in avoiding dangerous sources. Because most reinfusions need to handle one or more circulating blood volumes, such a procedure will amplify the deleterious effects on blood (proteins, forming elements, etc.). Moreover, since autologous blood reinfusion devices more or less form the extracorporeal blood circuit, regardless of the intended use or application of these devices, the performance criteria of these devices should consider the performance of such aspects as the extracorporeal circuit of cardiac surgery and non-cardiac surgery. The blood collected from the open wound surface is in contact with external substances other than air,
thromboplastin, chips, fat, and other circulatory systems, so it is contaminated blood. Air can be removed through the reservoir, which is usually not a problem in autologous blood reinfusion devices equipped with an external oxygenator. However, when using the direct blood contact interface to quickly introduce blood into the patient with air pressure, air pollution becomes a problem. Because there is no air capture device in the oxygenator, it is dangerous to use Note. When the manufacturer gives the centrifuge speed, the test is carried out in accordance with the centrifuge speed given by the manufacturer. Otherwise, the test is carried out in accordance with the centrifuge speed of 5600 r/min. B.5 Residual amount
At 23 °C ± 2 °C ambient conditions, WEIGH (accurate to 0.1 g) separation bowl, PLACE it in the autologous blood recovery set, in accordance with conventional use method or instruction manual, INSTALL and CONNECT the centrifugal
bowl type blood cell recovery set, USE the distilled water at 23 °C ± 2 °C as a circulation solution. MAKE adjustment and control in accordance with
autologous blood recovery set operating procedures, MAKE it circulate once at the centrifuge speed 5600 r/min, after the reinfusion is completed, WEIGH the separation bowl again, USE the difference between the two weighing results divided by the water density (taken as 1 g/mL) to obtain the separation bowl blood residual amount.
Note. When the manufacturer gives the centrifuge speed, the test is carried out in acc...