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YY/T 0992-2023Endoscopic washing station (English PDF)

内镜清洗工作站

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 20, 2023

Implementation date

July 1, 2024

Scope

YY/T 0992-2023 is the English-translated version of 内镜清洗工作站.

YY/T 0992-2023 is the Chinese standard "Endoscopic washing station".

Its scope clause reads: This document specifies the classification and type, requirements, signs, instructions for use, and packages of endoscope cleaning workstations (hereinafter referred to as endoscope workstations). packaging, transportation and storage, and the corresponding test methods are described.

This document is suitable for manual cleaning of soft or rigid endoscopes mainly used in medical institutions and can be disinfected with chemical disinfectants. endoscopy workstation.

This document does not apply to products used for cleaning and disinfection of medical devices other than flexible endoscopes and rigid endoscopes. Its clauses include normative reference documents; terms and definitions.

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Document preview — YY/T 0992-2023

National Standard of the People's Republic of China

ICS: 11.080.10
Classification: C47
Replacing: YY/T 0992-2016

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative reference documents
3 Terms and Definitions
4 Classification and Type
4.1 Category
4.2 Type
5 Requirement
5.1 Normal working conditions
5.2 General requirements
5.3 Functional slot requirements
5.4 Noise
5.5 Safety requirements
6 Test method
6.1 Test conditions
6.2 General requirements test
6.3 Function slot test
6.4 Noise test
6.5 Safety requirements test
7 Logo, packaging, instructions for use, transportation, storage
7.1 Flag
7.2 Packaging
7.3 User Manual
7.4 Transport
7.5 Storage

1 Scope

This document specifies the classification and type, requirements, signs, instructions for use, and packages of endoscope cleaning workstations (hereinafter referred to as endoscope workstations).

packaging, transportation and storage, and the corresponding test methods are described.

This document is suitable for manual cleaning of soft or rigid endoscopes mainly used in medical institutions and can be disinfected with chemical disinfectants.

endoscopy workstation.

This document does not apply to products used for cleaning and disinfection of medical devices other than flexible endoscopes and rigid endoscopes.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 191 Packaging, storage and transportation pictorial mark

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements

GB 4793.4 Safety requirements for electrical equipment for measurement, control and laboratory use Part 4.Sterilizers for processing medical materials and special requirements for washer-disinfectors

GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements

GB/T 35267-2017 Endoscope washer and disinfector

YY/T 0466.1 Medical devices Symbols used for labeling, marking and providing information on medical devices Part 1.General requirements

YY/T 0734.1-2018 Washer-disinfector Part 1.General requirements and tests

Pharmacopoeia of the People's Republic of China (Part 2) (2020 Edition)

3 Terms and definitions

The terms and definitions defined in YY/T 0734.1 and the following apply to this document.

3.1

It is composed of different functional slots and accessories. It is used for manual cleaning of endoscopes and can use chemical disinfectants for disinfection.

facility.

3.2 perfusion

A device that injects liquid into the endoscope lumen for the purpose of cleaning and/or disinfecting the interior of the endoscope lumen.

3.3 rinsing

The process of rinsing the residue on the endoscope with running water.

3.4 final rinsingfinalrinsing

The process of final rinsing of disinfected endoscopes with purified or sterile water.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 0802.1|YY 1277|YY/T 1268|YY/T 0679

Editions of YY/T 0992

Edition	Title	Revision	Status
YY/T 0992-2023	Endoscopic washing station	current edition	Current
YY/T 0992-2016	Endoscopic washing station	previous edition	In force until 2024-07-01

This page sells the current edition, YY/T 0992-2023. Earlier editions are listed for reference only.

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