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GB 30689-2026: Hygienic requirements for automated washer-disinfector for endoscope
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GB 30689-2026	English	279	Add to Cart	3 days [Need to translate]	Hygienic requirements for automated washer-disinfector for endoscope
GB 30689-2014	English	209	Add to Cart	3 days [Need to translate]	Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

GB 30689-2026: Hygienic requirements for automated washer-disinfector for endoscope

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ICS 11.080 CCSC59 National Standards of the People's Republic of China Replaces GB 30689-2014 Hygiene requirements for automatic endoscope cleaning and disinfection machines Published on 2026-01-28 Implemented on February 1, 2027 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Table of contents

Preface III 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4 Performance Requirements 2 5 Control Requirements 3 6.Health Indicators and Testing Methods 4 7.Transportation, storage and packaging 5. 8.Labels, nameplates, and instruction manuals 5 Appendix A (Normative) Methods for Evaluating Laboratory Disinfection Effectiveness 7

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 GB 30689-2014 "Hygienic Requirements for Automatic Endoscope Cleaning and Disinfection Machines". Compared with GB 30689-2014, the main differences are in the structural design. Aside from integration and editorial changes, the main technical changes are as follows. ---The scope has been changed (see Chapter 1, Chapter 1 of the.2014 edition); ---Terminology and definitions have been changed (see Chapter 3, Chapter 3 of the.2014 edition); ---The section "Name and Model" has been removed (see Chapter 4 of the.2014 edition); ---Performance requirements have been changed, and general requirements have been added (see 4.1, Chapter 5 of the.2014 version); ---The requirements for leak detection, cleaning, disinfection temperature, and terminal rinsing have been changed (see 4.2, 4.3, 4.4.2, 4.5; 5.1 and 5.2 in the.2014 edition). 5.3.1, 5.3.2, 5.4); ---Control requirements have been changed (see 5.1.4, 6.3 and 6.4 in the.2014 version); ---Added requirements for record-keeping and traceability systems (see 5.4); ---Added health indicators and testing methods (see Chapter 6); ---The electrical safety requirements have been removed (see Chapter 7 of the.2014 edition); ---Added requirements for nameplates and instruction manuals (see 8.1, 8.2). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed and is under the jurisdiction of the National Center for Disease Control and Prevention. The release history of this document and the document it replaces is as follows. ---First published in.2014 as GB 30689-2014; ---This is the first revision. Hygiene requirements for automatic endoscope cleaning and disinfection machines

1 Scope

This document specifies the performance requirements, control requirements, hygiene standards, transportation, storage and packaging, labeling, and nameplates for automated endoscope cleaning and disinfection machines. The instructions for use describe the testing methods for hygiene indicators. This document applies to automated cleaning and sterilization machines for flexible endoscopes.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 191 Packaging and Storage Graphic Symbols GB 5749 Standard for Drinking Water Quality GB 15979-2024 Hygienic requirements for disposable sanitary products GB 28232 Hygiene requirements for ozone sterilizers GB 28234 Hygienic requirements for acidic water electrolysis generators GB/T 38497 Evaluation Method for Endoscope Disinfection Effect GB 38598 General Requirements for Labeling and Instructions for Disinfection Products WS/T 10009 Test Methods for Disinfection Products Pharmacopoeia of the People's Republic of China

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Automated equipment for cleaning and disinfecting flexible endoscopes. Note. Abbreviated as endoscope cleaning and disinfection machine. 3.2 Leakage test This involves checking to ensure the integrity of the endoscope's surface and channels. 3.3 Self-disinfection cycle When unloaded, the endoscope washer/disinfector itself circulates all liquids that come into contact with the water or solution used for cleaning, disinfecting, and rinsing instruments. Disinfection treatment is carried out on the system, cavity, water tank and other components. 3.4 medical detergent A formulation used to enhance the cleaning effect of water on contaminants on medical devices, instruments and other related items. ...