GB 30689-2026 Hygienic requirements for automated washer-disinfector for endoscope English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS
CCS
National Standard of the People's Republic of China
GB 30689-2026
Hygienic requirements for automated washer-disinfector for endoscope
内镜自动清洗消毒机卫生要求
Issue date: 2026-01-28 Implementation date: 2027-02-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
1 Scope
2 Normative References
3 Terms and Definitions
4 Performance Requirements
5 Control Requirements
6 Hygiene Indicators and Test Methods
7 Transport, Storage and Packaging
8 Identification, Nameplate and Instruction Manual
Annex A (Normative) Evaluation Method for Laboratory Disinfection Effectiveness
Hygienic requirements for automated washer disinfector for endoscope
1 Scope
This document specifies the requirements for performance requirements, control requirements, hygiene indicators, transport, storage and packaging, identification, nameplate and instruction manual for automated washer disinfectors for endoscopes, and describes the test methods for hygiene indicators.
This document applies to automated washer disinfectors for flexible endoscopes.
2 Normative References
The contents of the following documents constitute essential provisions of this document through normative reference. For dated references, only the edition cited applies. For undated references, the latest edition (including all amendments) applies.
GB/T 191 Packaging — Pictorial marking for handling of goods
GB 5749 Hygienic standard for drinking water
GB 15979-2024 Hygienic requirements for disposable sanitary products
GB 28232 Hygienic requirements for ozone disinfector
GB 28234 Hygienic requirements for acidic electrolyzed water generator
GB/T 38497 Evaluation method of endoscope disinfection effect
GB 38598 General requirements for labeling and instruction manual of disinfection products
WS/T 10009 Test method of disinfection products
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 automated washer disinfector for endoscope
An automated device that performs cleaning and disinfection of flexible endoscopes.
NOTE: Hereinafter referred to as "endoscope washer disinfector".
3.2 leak test
A test to confirm whether the surface and channels of an endoscope are intact.
3.3 self disinfection cycle
When unloaded, the disinfection treatment carried out by the endoscope washer disinfector on all liquid circulation systems, chambers, tanks and other components that come into contact with water or solutions used for cleaning, disinfecting and rinsing instruments.
3.4 medical detergent
A preparation used to enhance the cleaning effect of water on contaminants on medical devices, instruments and other related items.
4 Performance requirements
4.1 General requirements
4.1.1 The endoscope washer disinfector shall have the functions of cleaning, disinfection, final rinsing, self disinfection and traceability.
4.1.2 When equipped with an automatic leak test function, if a leak in the endoscope is detected, there shall be a visible or audible alarm signal, and the running program shall be automatically interrupted or operationally controlled. When equipped with an interactive leak test function, bubbles shall be visible at the leak point.
4.1.3 When equipped with a drying function, the internal surfaces of the endoscope after drying shall show no visible water marks.
4.1.4 When the endoscope washer disinfector uses freshly prepared disinfectant, it shall be provided with a disinfectant sampling port or a sampling and detection function. When equipped with a final rinse water purification and disinfection function, it shall be provided with a final rinse water sampling port.
4.1.5 The endoscope washer disinfector shall adopt a double door, single door, flip door or drawer door configuration.
4.2 Leak test
When the endoscope washer disinfector has an automatic leak test function, it shall ensure that the endoscope is not damaged by liquid entering during the operating cycle. The parameters of the endoscope washer disinfector leak test (e.g., pressure, duration, maximum allowable leakage) shall be consistent with the parameters marked in the instruction manual. The test procedure shall ensure that one leak test is completed before the endoscope comes into contact with the liquid inside the endoscope washer disinfector.
4.3 Cleaning
4.3.1 Rinsing
The endoscope washer disinfector shall be capable of rinsing both the internal and external surfaces of the endoscope. The rinsing water shall not be reused and shall be drained after each stage is completed.
4.3.2 Detergent washing
The manufacturer of the endoscope washer disinfector shall recommend a compatible medical detergent. The washing water containing the medical detergent shall not be reused and shall be drained after each stage is completed.
4.3.3 Rinsing
It shall be ensured that residual detergent does not affect the disinfection effectiveness. The quality of the rinsing water shall comply with the requirements of the endoscope washer disinfector manufacturer and with GB 5749. The rinsing water shall not be reused and shall be drained after each stage is completed.
4.4 Disinfection
4.4.1 The manufacturer of the endoscope washer disinfector shall recommend a compatible disinfectant, and the disinfectant used shall comply with relevant hygiene standards.
4.4.2 The disinfection temperature shall be within the temperature tolerance range of the endoscope, and the disinfection temperature shall meet the requirements of the disinfectant manufacturer.
4.4.3 The disinfection stage shall be timed and shall be displayed on a screen.
4.5 Final rinsing
For final rinsing, final rinse water that meets the hygiene requirements of 6.1.3.1 shall be used. The final rinse water shall be treated using a disinfection treatment device. For sterilised endoscopes, the final rinse water shall be simultaneously treated with a filter membrane of 0.2 μm or less and a halogen resin filter cartridge. The residual disinfectant level after rinsing shall comply with the requirements of relevant national standards or the instruction manual. The final rinse water shall not be reused and shall be drained after each stage is completed.
4.6 Drying
When an endoscope drying procedure is provided, residual rinse water inside the instrument channels may be blown out using filtered air. After drying is completed, the internal channel surfaces of the instrument shall show no visible water marks. If an alcohol drying procedure is provided, it shall be ensured that it does not damage the endoscope.
4.7 Self disinfection
Standard
GB 30689-2026 Hygienic requirements for automated washer-disinfector for endoscope (English)
Standard No.
GB 30689-2026
Status
to be valid
Language
English
File Format
PDF
Word Count
8500 words
Translation Price(USD)
255.0
Implemented on
2027-2-1
Delivery
via email in 1~3 business day
Detail of GB 30689-2026
Standard No.
GB 30689-2026
English Name
Hygienic requirements for automated washer-disinfector for endoscope
GB 30689-2026 Hygienic requirements for automated washer-disinfector for endoscope English, Anglais, Englisch, Inglés, えいご
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
ICS
CCS
National Standard of the People's Republic of China
GB 30689-2026
Hygienic requirements for automated washer-disinfector for endoscope
内镜自动清洗消毒机卫生要求
Issue date: 2026-01-28 Implementation date: 2027-02-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
1 Scope
2 Normative References
3 Terms and Definitions
4 Performance Requirements
5 Control Requirements
6 Hygiene Indicators and Test Methods
7 Transport, Storage and Packaging
8 Identification, Nameplate and Instruction Manual
Annex A (Normative) Evaluation Method for Laboratory Disinfection Effectiveness
Hygienic requirements for automated washer disinfector for endoscope
1 Scope
This document specifies the requirements for performance requirements, control requirements, hygiene indicators, transport, storage and packaging, identification, nameplate and instruction manual for automated washer disinfectors for endoscopes, and describes the test methods for hygiene indicators.
This document applies to automated washer disinfectors for flexible endoscopes.
2 Normative References
The contents of the following documents constitute essential provisions of this document through normative reference. For dated references, only the edition cited applies. For undated references, the latest edition (including all amendments) applies.
GB/T 191 Packaging — Pictorial marking for handling of goods
GB 5749 Hygienic standard for drinking water
GB 15979-2024 Hygienic requirements for disposable sanitary products
GB 28232 Hygienic requirements for ozone disinfector
GB 28234 Hygienic requirements for acidic electrolyzed water generator
GB/T 38497 Evaluation method of endoscope disinfection effect
GB 38598 General requirements for labeling and instruction manual of disinfection products
WS/T 10009 Test method of disinfection products
Pharmacopoeia of the People's Republic of China
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 automated washer disinfector for endoscope
An automated device that performs cleaning and disinfection of flexible endoscopes.
NOTE: Hereinafter referred to as "endoscope washer disinfector".
3.2 leak test
A test to confirm whether the surface and channels of an endoscope are intact.
3.3 self disinfection cycle
When unloaded, the disinfection treatment carried out by the endoscope washer disinfector on all liquid circulation systems, chambers, tanks and other components that come into contact with water or solutions used for cleaning, disinfecting and rinsing instruments.
3.4 medical detergent
A preparation used to enhance the cleaning effect of water on contaminants on medical devices, instruments and other related items.
4 Performance requirements
4.1 General requirements
4.1.1 The endoscope washer disinfector shall have the functions of cleaning, disinfection, final rinsing, self disinfection and traceability.
4.1.2 When equipped with an automatic leak test function, if a leak in the endoscope is detected, there shall be a visible or audible alarm signal, and the running program shall be automatically interrupted or operationally controlled. When equipped with an interactive leak test function, bubbles shall be visible at the leak point.
4.1.3 When equipped with a drying function, the internal surfaces of the endoscope after drying shall show no visible water marks.
4.1.4 When the endoscope washer disinfector uses freshly prepared disinfectant, it shall be provided with a disinfectant sampling port or a sampling and detection function. When equipped with a final rinse water purification and disinfection function, it shall be provided with a final rinse water sampling port.
4.1.5 The endoscope washer disinfector shall adopt a double door, single door, flip door or drawer door configuration.
4.2 Leak test
When the endoscope washer disinfector has an automatic leak test function, it shall ensure that the endoscope is not damaged by liquid entering during the operating cycle. The parameters of the endoscope washer disinfector leak test (e.g., pressure, duration, maximum allowable leakage) shall be consistent with the parameters marked in the instruction manual. The test procedure shall ensure that one leak test is completed before the endoscope comes into contact with the liquid inside the endoscope washer disinfector.
4.3 Cleaning
4.3.1 Rinsing
The endoscope washer disinfector shall be capable of rinsing both the internal and external surfaces of the endoscope. The rinsing water shall not be reused and shall be drained after each stage is completed.
4.3.2 Detergent washing
The manufacturer of the endoscope washer disinfector shall recommend a compatible medical detergent. The washing water containing the medical detergent shall not be reused and shall be drained after each stage is completed.
4.3.3 Rinsing
It shall be ensured that residual detergent does not affect the disinfection effectiveness. The quality of the rinsing water shall comply with the requirements of the endoscope washer disinfector manufacturer and with GB 5749. The rinsing water shall not be reused and shall be drained after each stage is completed.
4.4 Disinfection
4.4.1 The manufacturer of the endoscope washer disinfector shall recommend a compatible disinfectant, and the disinfectant used shall comply with relevant hygiene standards.
4.4.2 The disinfection temperature shall be within the temperature tolerance range of the endoscope, and the disinfection temperature shall meet the requirements of the disinfectant manufacturer.
4.4.3 The disinfection stage shall be timed and shall be displayed on a screen.
4.5 Final rinsing
For final rinsing, final rinse water that meets the hygiene requirements of 6.1.3.1 shall be used. The final rinse water shall be treated using a disinfection treatment device. For sterilised endoscopes, the final rinse water shall be simultaneously treated with a filter membrane of 0.2 μm or less and a halogen resin filter cartridge. The residual disinfectant level after rinsing shall comply with the requirements of relevant national standards or the instruction manual. The final rinse water shall not be reused and shall be drained after each stage is completed.
4.6 Drying
When an endoscope drying procedure is provided, residual rinse water inside the instrument channels may be blown out using filtered air. After drying is completed, the internal channel surfaces of the instrument shall show no visible water marks. If an alcohol drying procedure is provided, it shall be ensured that it does not damage the endoscope.
4.7 Self disinfection
