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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0992-2023: Endoscopic washing station Status: Valid YY/T 0992: Historical versions
Basic dataStandard ID: YY/T 0992-2023 (YY/T0992-2023)Description (Translated English): Endoscopic washing station Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.10 Word Count Estimation: 13,192 Date of Issue: 2023-06-20 Date of Implementation: 2024-07-01 Older Standard (superseded by this standard): YY/T 0992-2016 Issuing agency(ies): State Drug Administration Summary: This standard specifies the classification, type, requirements, signs, instructions, packaging, transportation and storage of endoscope cleaning workstations (hereinafter referred to as endoscope workstations), and describes the corresponding test methods. This standard applies to endoscope workstations that are mainly used in medical institutions for manual cleaning of soft or hard endoscopes and can be disinfected with chemical disinfectants. This standard does not apply to products for cleaning and disinfecting medical devices other than flexible endoscopes and rigid endoscopes. YY/T 0992-2023: Endoscopic washing station---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.ICS 11.080.10 CCSC47 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0992-2016 Endoscope cleaning workstation Published on 2023-06-20 2024-07-01 Implementation Released by the State Drug Administration Table of contentsPreface III 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Classification and Type 2 4.1 Category 2 4.2 Type 2 5 Requirement 2 5.1 Normal working conditions 2 5.2 General requirements 2 5.3 Functional slot requirements 3 5.4 Noise 5 5.5 Safety requirements 5 6 Test method 5 6.1 Test conditions 5 6.2 General requirements test 5 6.3 Function slot test 6 6.4 Noise test 7 6.5 Safety requirements test 7 7 Logo, packaging, instructions for use, transportation, storage 7 7.1 Flag 7 7.2 Packaging8 7.3 User Manual 8 7.4 Transport8 7.5 Storage 8ForewordThis 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); ---Changed the requirements for disinfection tanks (see 5.3.5,.2016 version of 5.3.5); ---Changed the final rinse tank requirements (see 5.3.6,.2016 version of 5.3.6); ---Changed the drying table requirements (see 5.3.7,.2016 version of 5.3.7); ---Changed the noise requirements (see 5.4,.2016 version of 5.4); ---Changed the security requirements (see 5.5,.2016 version of 5.5); ---Deleted environmental test requirements and test methods (see 5.6 and 6.6 of the.2016 edition); ---Changed the appearance and structure test (see 6.2.1,.2016 version of 6.2.1); ---Changed the specification and size test (see 6.2.2,.2016 version of 6.2.2); ---Changed the testing of pipe fittings, components and information systems (see 6.2.4,.2016 version of 6.2.4); ---Changed the initial washing tank test (see 6.3.1,.2016 version of 6.3.1); ---Changed the cleaning tank test (see 6.3.2,.2016 version of 6.3.2); ---Changed the ultrasonic tank test (see 6.3.3,.2016 version of 6.3.3); ---Changed the rinse tank test (see 6.3.4,.2016 version of 6.3.4); ---Changed the disinfection tank test (see 6.3.5,.2016 version of 6.3.5); ---Changed the final rinse tank test (see 6.3.6,.2016 version of 6.3.6); ---Changed the drying bench test (see 6.3.7,.2016 version of 6.3.7); ---Changed the noise test (see 6.4,.2016 version of 6.4); ---Changed the marking requirements (see 7.1,.2016 version of 7.1); ---Changed the requirements for the instruction manual (see 7.3,.2016 version of 7.3). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200). This document was drafted by. Shandong Xinhua Medical Devices Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Guangdong Pharmaceuticals Supervision and Administration Review and Certification Center, Guangzhou Jihao Medical Technology Co., Ltd., the First Affiliated Hospital of Sun Yat-sen University, Zibo Golden Arrow Medical Equipment Co., Ltd. Ltd. The main drafters of this document. Feng Hongying, Liao Huier, Chen Zhuo, Cheng Jun, Tang Xiaowei, Zhai Shuyuan, Yu Huatong, Liu Chunyan, Xu Wei, Luan Kai, Du Heying. The previous versions of this document and the documents it replaces are as follows. ---First released in.2016 as YY/T 0992-2016; ---This is the first revision. Endoscope cleaning workstation1 ScopeThis 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 documentsThe 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 definitionsThe 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. ...... |
