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Blood thawing device
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Basic data
| Standard ID | YY/T 1945-2025 (YY/T1945-2025) |
| Description (Translated English) | Blood thawing device |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 13,182 |
| Date of Issue | 2025-06-18 |
| Date of Implementation | 2027-07-01 |
| Issuing agency(ies) | National Medical Products Administration |
| Summary | This standard specifies the requirements for blood melting equipment (hereinafter referred to as melting equipment) and describes the corresponding test methods. This document applies to melting equipment using the constant temperature water thawing principle. This document does not apply to plasma melting equipment for preparing cryoprecipitate or melting equipment using microwave oven methods, radio frequency methods, or dry hot air methods. |
YY/T 1945-2025: Blood thawing device
---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 11.100
CCSC44
Pharmaceutical Industry Standards of the People's Republic of China
Blood melting equipment
Published on 2025-06-18
Implemented on July 1, 2027
National Medical Products Administration issued
Table of contents
Preface III
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Requirements 1
5.Test Methods 3
References 8
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document was prepared by the Medical Equipment Subcommittee of the National Technical Committee on Standardization of Measurement, Control and Laboratory Electrical Equipment Safety.
(SAC/TC338/SC1) is under its jurisdiction.
This document was drafted by. Shandong Weigao Group Medical Polymer Products Co., Ltd., and Beijing Institute for Medical Device Testing (Beijing).
(Municipal Medical Biological Protective Equipment Testing and Research Center), Shandong Provincial Food and Drug Evaluation and Inspection Center, Shandong Provincial Medical Device and Drug Packaging Inspection Center
Research Institute, Shandong Provincial Blood Center, Suzhou Medical Instrument Factory, Wuhan Beso Medical Device Co., Ltd., Liaoning Provincial Medical Device Testing and Inspection Center
The institute, Shandong Boke Scientific Instruments Co., Ltd., Qingdao Haier Biomedical Co., Ltd., and Shandong Xinhua Medical Instruments Co., Ltd.
The main drafters of this document are. Yue Fangchao, Huang Yanchun, Mou Pengtao, Li Guoyong, He Weidong, Zhang Yiwei, Jin Can, Wang Bo, Wei Guosheng, and Li Weiyang.
Liu Xincheng, Chen Haitao, Guo Chenghu.
Blood melting equipment
1 Scope
This document specifies the requirements for blood melting equipment (hereinafter referred to as melting equipment) and describes the corresponding test methods.
This document applies to melting equipment that uses the principle of constant temperature water thawing.
This document does not apply to plasma melting equipment used for preparing cryoprecipitate or melting equipment using microwave ovens, radio frequency methods, or dry hot air methods.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measuring, control and laboratory use – Part 1.General requirements
GB/T 42125.1 Safety requirements for electrical equipment for measuring, control and laboratory use – Part 1.General requirements
GB/T 42125.2 Safety requirements for electrical equipment for measuring, controlling and laboratory use – Part 2.Laboratory equipment for heating materials
Special requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Plastic blood bags containing frozen blood components are placed in a thawing area, where the frozen blood components are thawed using constant-temperature water.
equipment.
3.2
Thawing Area
The area specified by the manufacturer for storing plastic blood bags containing frozen blood components.
3.3
bloodcomponents
Blood products made by separating one or more blood components from whole blood under certain conditions and using specific methods, and apheresis products.
A general term for blood division.
[Source. GB 18469-2012, 3.4]
4 Requirements
4.1 Working conditions
4.1.1 Ambient temperature. 10℃~30℃.
4.1.2 Relative humidity. not greater than 80%.
...
