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YY/T 0086-2020: Medical refrigerator
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 0086-2020	English	359	Add to Cart	4 days [Need to translate]	Medical refrigerator
YY/T 0086-2007	English	519	Add to Cart	3 days [Need to translate]	Pharmaceutical refrigerator
YY 0086-1992	English	519	Add to Cart	4 days [Need to translate]	(Drug Reefer)

YY/T 0086-2020: Medical refrigerator

---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 refrigerator ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0086-2007, YY/T 0168-2007 Medical refrigerator Released on 2020-02-21 2022-01-01 Implementation Issued by the State Drug Administration

Contents

Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Product Category 3 5 Requirement 4 6 Test method 7 7 Logo 16 8 Packaging, Transportation and Storage 16

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0086-2007 "Pharmaceutical Refrigerator" and YY/T 0168-2007 "Blood Refrigerator". Compared with YY/T 0086-2007 and YY/T 0168-2007, the main technical changes of this standard are as follows. --- Modified the temperature range in the box and removed the volume limit (see Chapter 1,.2007 edition YY/T 0086 and Chapter 1 of YY/T 0168); --- Modify and add normative references (see Chapter 2, Chapter 2 of.2007 edition YY/T 0086 and YY/T 0168); --- Modify and add terms and definitions (see Chapter 3,.2007 edition YY/T 0086 and YY/T 0168 Chapter 3); --- Modify the form and basic parameters for product classification, and increase the classification method (see Chapter 4,.2007 edition YY/T 0086 and Chapter 4 of YY/T 0168, 4.1); --- Deleted the basic parameters in the form and basic parameters (see the.2007 version YY/T 0086 and 4.2 of YY/T 0168); --- Modify and add the name and content of the technical requirements (see Chapter 5,.2007 edition YY/T 0086 and YY/T 0168 section 5 chapter); --- Increased electromagnetic compatibility (see 5.14); --- Modify and add the test method (see Chapter 6,.2007 edition YY/T 0086 and YY/T 0168 Chapter 7); --- Deleted inspection rules (see Chapter 8 of.2007 edition YY/T 0086 and YY/T 0168); --- Revised the logo (see Chapter 7,.2007 edition YY/T 0086 and YY/T 0168 9.1); --- Modified the packaging, transportation and storage (see Chapter 8, 9.2 and 9.3 of the.2007 edition of YY/T 0086 and YY/T 0168); --- Deleted Appendix A (see Appendix A of.2007 edition YY/T 0086 and YY/T 0168). Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents. This standard was proposed by the State Drug Administration. This standard is composed of the Medical Device Sub-Technical Committee (SAC / TC338/SC1). This standard was drafted. Liaoning Medical Device Inspection and Testing Institute, Qingdao Haier Biomedical Co., Ltd., Panasonic Cold Chain (Dalian) Co., Ltd., Beijing Medical Device Inspection Institute, Shandong Food and Drug Administration Evaluation and Certification Center. The main drafters of this standard. Wang Bo, Liu Zhanjie, Niu Yutao, Cui Jiehui, Liu Fazhu, Jin Ye, Liang Zhenshi, Feng Lei, Zhang Yi. The previous versions of the standard replaced by this standard are as follows. --- YY/T 0086-2007, YY 0086-1992; --- YY/T 0168-2007, YY 0168-1994. Medical refrigerator

1 Scope

This standard specifies the terms and definitions, product classification, requirements, test methods, marking, packaging, transportation, and storage of medical refrigerators. This standard applies to the temperature range in the box is 2 ℃ ~ 8 ℃, assembled by the factory, using a motor-driven compressor to cool, internally Medical refrigerated containers for storing products (hereinafter referred to as refrigerated containers) cooled by natural convection or forced convection, including medical blood Liquid refrigerator (hereinafter referred to as blood refrigerator).

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document. GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Part 1. General Requirements GB/T 14710 Environmental requirements and test methods for medical appliances GB/T 18268.1 Requirements for electromagnetic compatibility of 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 blood refrigerator medicalbloodrefrigerator It is only used for refrigerators for storing blood. The temperature of the refrigerator is in accordance with the requirements for storing blood. The temperature setting is 4 ℃ by default. adjustable. 3.2 Inventory deposit Items for medical or similar purposes such as blood, vaccines, reagents, and biological agents that are to be stored in the refrigerator, such as those in blood refrigerators The stock is blood. 3.3 Top-opening (refrigerator) top-openingtyperefrigerator Refrigerators for storing products through the top door or lid. 3.4 Upright (vertical) refrigerator uprighttyperefrigerator Refrigerators for storing products through the front door or lid. 3.5 Overall dimensions overaldimensions When the door or lid is closed, the size of the space occupied by the refrigerator is expressed in the form of (height × width × depth). 3.6 Volume The space inside the refrigerator measured according to the test method of 6.2. ...