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YY/T 1902-2024: Medical plasma quick freezer
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1902-2024 | English | 299 |
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Medical plasma quick freezer
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YY/T 1902-2024
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Basic data | Standard ID | YY/T 1902-2024 (YY/T1902-2024) | | Description (Translated English) | Medical plasma quick freezer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 14,192 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2026-03-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the product classification and requirements for medical plasma quick freezing machines (hereinafter referred to as quick freezing machines), and describes the corresponding test methods. This document applies to medical plasma quick freezing machines. This document does not apply to quick freezers using heat transfer methods other than clamping and air-cooling. | YY/T 1902-2024: Medical plasma quick freezer---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
Medical plasma quick freezing machine
Released on 2024-02-07
2026-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Product Categories 2
5 Requirement 3
6 Test methods 5
Reference 10
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 is required.
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 was prepared by the National Technical Committee for Safety Standardization of Measurement, Control and Laboratory Electrical Equipment, Medical Equipment Subcommittee
(SAC/TC338/SC1) is responsible for this matter.
This document was drafted by. Liaoning Medical Device Inspection and Testing Institute, Beijing Medical Device Inspection Institute (Beijing Medical Bioprotection Institute
Equipment Inspection Research Center), Anhui Food and Drug Inspection Institute, Shandong Medical Device and Drug Packaging Inspection Institute, Peking University
Third Hospital, Qingdao Haier Biomedical Co., Ltd., Wuhan Beso Medical Equipment Co., Ltd., Zhengzhou Feilong Medical Equipment Co., Ltd.,
Shansongyang Biotechnology (Dalian) Co., Ltd. and Zhongke Meiling Cryogenic Technology Co., Ltd.
The main drafters of this document are. Yang Yan, Wang Bo, Feng Lei, Zhao Yongxin, Zhang Ke, Wang Dong, Jiao Qiang, Huang Yanchun, Ye Xiaocan, Chen Haitao, Jin Can, Shen Yan
Kui, Liu Fazhu, Qu Yaohui, Yuan Shuntao, Yao Benhu, and Su Meihua.
Medical plasma quick freezing machine
1 Scope
This document specifies the product classification and requirements of medical plasma quick freezers (hereinafter referred to as quick freezers) and describes the corresponding test methods.
This document applies to medical plasma quick freezing machines.
This document does not apply to quick freezers using heat transfer methods other than clamp-on and air-cooled types.
2 Normative references
The contents of the following documents constitute the 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 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Medical equipment used to quickly freeze plasma products.
3.2
A heat conduction quick freezer in which the cold plate (3.13) contacts the plasma bag by clamping.
3.3
A thermal convection quick freezer that uses forced air cooling convection to quickly freeze plasma products.
3.4
Overalquickfreezer
A quick freezer with all components (including refrigeration device and automatic control device, etc.) assembled in one.
3.5
Split quick freezer splitquickfreezer
The quick freezer consists of two parts. indoor and outdoor.
3.6
Quick freezer for plasma products, accessed through the front door.
3.7
A quick freezer for placing and removing plasma products through a top door or lid.
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