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YY/T 1902-2024Medical plasma quick freezer (English PDF)

医用血浆速冻机

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 7, 2024

Implementation date

March 1, 2026

Scope

YY/T 1902-2024 is the English-translated version of 医用血浆速冻机.

YY/T 1902-2024 is the Chinese standard "Medical plasma quick freezer". Its scope clause reads: This document specifies the product classification and requirements of medical plasma quick freezers (hereinafter referred to as quick freezers) and describes the corresponding test methods.

This document applies to medical plasma quick freezing machines. This document does not apply to quick freezers using heat transfer methods other than clamp-on and air-cooled types. Its clauses include terms and definitions.

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Document preview — YY/T 1902-2024

National Standard of the People's Republic of China

ICS
11.100
Classification
C44

Issued by: National Medical Products Administration

Contents

  • Preface
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Product Categories
  • 5 Requirement
  • 6 Test methods

1 Scope

This document specifies the product classification and requirements of medical plasma quick freezers (hereinafter referred to as quick freezers) and describes the corresponding test methods.

This document applies to medical plasma quick freezing machines.

This document does not apply to quick freezers using heat transfer methods other than clamp-on and air-cooled types.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies 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

Medical equipment used to quickly freeze plasma products.

3.2

A heat conduction quick freezer in which the cold plate (3.13) contacts the plasma bag by clamping.

3.3

A thermal convection quick freezer that uses forced air cooling convection to quickly freeze plasma products.

3.4 Overalquickfreezer

A quick freezer with all components (including refrigeration device and automatic control device, etc.) assembled in one.

3.5 Split quick freezer

The quick freezer consists of two parts. indoor and outdoor.

3.6

Quick freezer for plasma products, accessed through the front door.

3.7

A quick freezer for placing and removing plasma products through a top door or lid.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 14 pages — is available in the English PDF.

Referenced standards

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