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YY/T 0086-2020: Medical refrigerator
Status: Valid YY/T 0086: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0086-2020 | English | 359 |
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4 days [Need to translate]
|
Medical refrigerator
| Valid |
YY/T 0086-2020
|
| YY/T 0086-2007 | English | 519 |
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3 days [Need to translate]
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Pharmaceutical refrigerator
| Obsolete |
YY/T 0086-2007
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| YY 0086-1992 | English | 519 |
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4 days [Need to translate]
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(Drug Reefer)
| Obsolete |
YY 0086-1992
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PDF similar to YY/T 0086-2020
Basic data | Standard ID | YY/T 0086-2020 (YY/T0086-2020) | | Description (Translated English) | Medical refrigerator | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.040 | | Word Count Estimation | 19,144 | | Date of Issue | 2020-02-21 | | Date of Implementation | 2022-01-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, product classification, requirements, test methods, marking, packaging, transportation and storage of medical refrigerators. This standard is applicable to medical refrigerators used for storing stored goods with the temperature range of 2�桫8��, assembled by the factory, refrigerated by motor-driven compressor, and cooled by natural air convection or forced convection inside. Includes medical blood coolers. | 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.
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