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

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents" Drafting. This document replaces YY/T 0992-2016 "Endoscope Cleaning Workstation". Compared with YY/T 0992-2016, except for structural adjustment and editing In addition to sexual changes, the main technical changes are as follows:

---Deleted the term and definition of "first wash" (see

3.2 of the.2016 edition);

---Changed the definitions of "rinsing" and "final rinsing" (see 3.3, 3.4, 3.4,

3.5 of the.2016 version);

---Added the terms and definitions of "leak detection" and "self-disinfection procedure" (see 3.7, 3.8);

---Changed the requirements for normal working conditions [see 5.1g),.2016 version of 5.1g)];

---Changed the appearance and structure (see 5.2.1,.2016 version of 5.2.1);

---Changed pipe fittings, components and information systems (see 5.2.4,.2016 version of 5.2.4);

---Added the requirements for its own disinfection procedures and its test methods (see 5.2.5, 6.2.5);

---Changed the requirements for the initial washing tank (see 5.3.1,.2016 version of 5.3.1);

---Changed the cleaning tank requirements (see 5.3.2,.2016 version of 5.3.2);

---Changed the ultrasonic tank requirements (see 5.3.3,.2016 version of 5.3.3);

1 Scope

YY/T 0992 is the Chinese standard for the endoscope washing station, the equipment that cleans and disinfects flexible endoscopes between patients. It sets the requirements such a station has to meet and the test methods that verify them, covering the wash and disinfection cycle, the handling of channels and connectors, the control and recording of the process and the safety of the operator working with the chemicals involved. Endoscope reprocessing is one of the recognised routes of hospital-acquired infection, and failures in it have caused outbreaks worldwide, which is why the process has to be machine-controlled and documented rather than left to hand cleaning. The 2023 edition replaces YY/T 0992-2016. For a manufacturer of reprocessing equipment this is the document a Chinese registration and a hospital tender both refer to.

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

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 deviceperfusiondevice 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.