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YY 0329-2024: Leukocyte reduction filters for single use
Status: Valid YY 0329: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0329-2024 | English | 529 |
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5 days [Need to translate]
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Leukocyte reduction filters for single use
| Valid |
YY 0329-2024
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| YY 0329-2009 | English | 629 |
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Leukocyte reduction filters for single use
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YY 0329-2009
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| YY 0329-2002 | English | 719 |
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Leukocyte removal filters for single use
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YY 0329-2002
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Basic data | Standard ID | YY 0329-2024 (YY0329-2024) | | Description (Translated English) | Leukocyte reduction filters for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 26,246 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0329-2009 | | Issuing agency(ies) | State Drug Administration | YY 0329-2024: Leukocyte reduction filters for single use---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.20
CCSC31
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0329-2009
Disposable Leukocyte Removal Filter
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and naming 1
5 Materials 1
6 Requirements and test methods 1
6.1 Physical properties 1
6.2 Chemical properties 2
6.3 Biological properties 3
6.4 Filtration performance 3
7 Logo 4
7.1 Primary packaging 4
7.2 Outer packaging 4
8 Packaging 4
Appendix A (Normative) Particle Content Determination Method---Particle Detector Method 5
Appendix B (Normative) Particle Content Determination Method---Microscope Counting Method (Arbitration Method) 6
Appendix C (Normative) Preparation of Chemical Property Test Solution 8
Appendix D (Normative) Method for determination of residual leukocytes --- ordinary optical microscope counting method 9
Appendix E (Normative) Method for determination of residual leukocytes --- fluorescence microscopy counting method (arbitration method) 11
Appendix F (Normative) Determination of free hemoglobin --- Tetramethylbenzidine method 12
Appendix G (Normative) Determination of free hemoglobin --- o-tolidine method (arbitration method) 14
Appendix H (Normative) Method for determination of red blood cell and platelet recovery rate 15
Appendix I (Normative) Platelet hypotonic shock relative change rate test 17
References 19
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY 0329-2009 "Disposable Leukocyte Removal Filter". Compared with YY 0329-2009, except for structural adjustments and
In addition to editorial changes, the main technical changes are as follows.
--- Changed the tightness test conditions (see 6.1.2, 5.1.2 of the.2009 edition);
--- Changed the protective device (set) (see 6.1.6, 5.1.6 of the.2009 edition);
--- Changed biocompatibility (see 6.3.1, 5.5 of the.2009 edition);
--- Sterility has been changed (see 6.3.2, 5.3.1 of the.2009 edition);
--- Changes to bacterial endotoxins (see 6.3.3, 5.3.2 of the.2009 edition);
--- Changed the residual white blood cell count (see 6.4.1, 5.4.1 of the.2009 edition);
--- Changed free hemoglobin (see 6.4.2, 5.4.2 of the.2009 edition);
--- Changed the red blood cell/platelet recovery rate (see 6.4.3, 5.4.3 of the.2009 edition);
--- Changed the relative change rate of platelet hypotonic shock (see 6.4.4, 5.4.4 of the.2009 edition);
--- Deleted the inspection rules (see Chapter 6 of the.2009 edition);
--- Deleted the hemolysis test (see Appendix J of the.2009 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2002 as YY 0329-2002, first revised in.2009;
---This is the second revision.
Disposable Leukocyte Removal Filter
1 Scope
This document specifies the classification and naming, materials, requirements, marking and packaging of single-use leukocyte removal filters and describes the corresponding tests.
method.
This document applies to single-use leukocyte removal filters (hereinafter referred to as "leukocyte removal filters").
Note. The leukocyte removal filter can be connected to a blood transfusion device, a blood collection/blood component separation system, and is used to remove leukocytes from blood and blood components.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 6682 Specifications and test methods for water used in analytical laboratories
GB 8369.1 Disposable blood transfusion sets Part 1.Gravity blood transfusion sets
GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
YY/T 0466.1 Symbols for medical devices used to provide information for manufacturers Part 1.General requirements
YY/T 0615.1 Requirements for labeling “sterile” medical devices Part 1.Requirements for terminally sterilized medical devices
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Classification and naming
Leukocyte-removal filters are divided into whole blood, red blood cell and platelet leukocyte-removal filters according to the blood components they filter.
The leukocyte removal filter for whole blood and red blood cells that meets the requirements of this document is marked. RFYY 0329-2024.
The leukocyte removal filter for platelets that meets the requirements of this document is marked. PFYY 0329-2024.
5 Materials
The materials used to manufacture leukocyte depletion filters shall meet the requirements of Chapter 6.
6 Requirements and test methods
6.1 Physical properties
6.1.1 Appearance
When tested with normal or corrected vision, the outer shell of the leukocyte removal filter should be smooth and free of obvious mechanical impurities, foreign matter, cracks, welding or adhesion.
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