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YY/T 1757-2021Medical freezer (English PDF)

医用冷冻保存箱

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 9, 2021

Implementation date

April 1, 2023

Scope

YY/T 1757-2021 is the English-translated version of 医用冷冻保存箱.

YY/T 1757-2021 is the Chinese pharmaceutical industry standard for the medical freezer, the closed motor-driven compression cabinet used to store blood, reagents and biological samples at low temperature.

It sets the classification of the products, the requirements, the test methods, and the rules for marking, packaging, transport and storage, covering the temperature the cabinet reaches and holds, the uniformity and stability of the temperature inside, the recovery after the door is opened, the alarms for temperature and power failure, the noise and the electrical safety.

Freezers for other temperature ranges may refer to it. Issued on 9 March 2021, it has applied since 1 April 2023.

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Document preview — YY/T 1757-2021

National Standard of the People's Republic of China

Classification: C 43

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

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Product Category
5 Requirements
6 Test method
7 Sign
8 Packaging, transportation and storage

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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°C~-164°C, 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

The freezer containing the stored products is accessed through the top door or lid.

3.4 Upright (vertical) freezer

Access the freezer containing the stored products through the front door.

3.5 Overall dimensions

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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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

Normative references

Similar standards

YY/T 1902-2024

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