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YY/T 1757-2021: Medical freezer
Status: Valid
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| YY/T 1757-2021 | English | 389 |
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Medical freezer
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YY/T 1757-2021
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Basic data | Standard ID | YY/T 1757-2021 (YY/T1757-2021) | | Description (Translated English) | Medical freezer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 21,268 | | Issuing agency(ies) | State Drug Administration | YY/T 1757-2021: Medical 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.
Medical freezer
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standards
Medical cryopreservation box
Released on 2021-03-09
2023-04-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Product Category 3
5 Requirements 3
6 Test method 8
7 Sign 18
8 Packaging, transportation and storage 18
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the Medical Equipment Sub-Committee of the National Technical Committee for Safety Standardization of Measurement, Control and Laboratory Electrical Equipment (SAC/
TC338/SC1) Centralized.
Drafting organizations of this standard. Liaoning Medical Device Inspection and Testing Institute, Anhui Food and Drug Inspection Research Institute, Beijing Medical Device Inspection
Institute, Qingdao Haier Biomedical Co., Ltd., Bingshan Songyang Biotechnology (Dalian) Co., Ltd., Zhongke Meiling Cryogenic Technology Co., Ltd.
Company, Thermo Fisher Scientific (China) Co., Ltd., Beijing Medical Device Technology Evaluation Center, and General Hospital of the People's Liberation Army.
The main drafters of this standard. Wang Bo, Ye Xiaocan, Feng Lei, Liu Fazhu, Su Meihua, Liu Zhanjie, Qu Yaohui, Yuan Shuntao, Yao Benhu, Zhang Yu,
Chen Ran, Zhao Xiumei.
Medical cryopreservation box
1 Scope
This standard specifies the product classification, requirements, test methods, marking, packaging, transportation and storage of medical cryopreservation boxes.
This standard is applicable to medical cryo-preservation boxes (hereinafter referred to as freezers) that use a closed motor-driven compression type, including medical cryogenic
Save the box. Medical cryopreservation equipment in other temperature ranges may refer to this standard.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable 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
An insulated box with appropriate volume and equipment, the temperature in the box can be controlled within -25℃~-164℃, using the means of power consumption
Comes for refrigeration, with one or more compartments. Under the specified conditions, when the temperature in the box reaches the set temperature, the medical institution can store the products.
These stored products reach the set temperature after a period of time and are stored reliably within the required temperature fluctuation range.
3.2
Deposit
Prepare the plasma, tissues, cells and other medical or similar items to be stored in the freezer.
3.3
Top-opening (horizontal) freezer top-openingtypefreezer
The freezer containing the stored products is accessed through the top door or lid.
3.4
Upright (vertical) freezer uprighttypefreezer
Access the freezer containing the stored products through the front door.
3.5
Overall dimensions overaldimensions
When the door or lid is closed, the size of the space occupied by the freezer is expressed in the form of height × width × depth.
3.6
Volume
The space inside the freezer measured in accordance with the test method in Section 6.2, in liters (L).
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