YY/T 1757-2021 English PDFUS$389.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1757-2021: Medical freezer Status: Valid
Basic dataStandard 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 contentsForeword 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 18ForewordThis 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 box1 ScopeThis 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 referencesThe 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 requirements3 Terms and definitionsThe 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). ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1757-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1757-2021_English as soon as possible, and keep you informed of the progress. 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