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YY/T 0086-2020Medical refrigerator (English PDF)

医用冷藏箱

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 21, 2020

Implementation date

January 1, 2022

Scope

YY/T 0086-2020 is the English-translated version of 医用冷藏箱.

YY/T 0086-2020 is the Chinese pharmaceutical industry standard for the medical refrigerator, the factory-assembled cabinet with a motor-driven compressor that holds its contents between 2 °C and 8 °C, cooled by natural or forced convection, including blood bank refrigerators.

It gives the terms and definitions, the classification of the products, the requirements, the test methods, and the rules for marking, packaging, transport and storage, covering the temperature reached and its uniformity and stability, the recovery after the door is opened, the temperature recorder and the alarms for temperature and power failure, the noise and the electrical safety. It was issued on 21 February 2020 and has applied since 1 January 2022.

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Document preview — YY/T 0086-2020

National Standard of the People's Republic of China

ICS
11.040
Classification
C 44
Replacing
YY/T 0168-2007

Issued by: National Medical Products Administration of the People's Republic of China

Contents

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

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).

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 °C ~ 8 °C, 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 document. 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

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 °C 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)

Refrigerators for storing products through the top door or lid.

3.4 Upright (vertical) refrigerator

Refrigerators for storing products through the front door or lid.

3.5 Overall dimensions

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Editions of YY/T 0086

EditionTitleRevisionStatus
YY/T 0086-2020Medical refrigeratorcurrent editionCurrent
YY/T 0168-2007Medical refrigeratorprevious editionSuperseded

This page sells the current edition, YY/T 0086-2020. Earlier editions are listed for reference only.

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