GB 30689-2014Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (English PDF)
内镜自动清洗消毒机卫生要求
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China
Level / Type
National · Mandatory
Issue date
December 22, 2014
Implementation date
July 1, 2015
Scope
GB 30689-2014 is the English-translated version of 内镜自动清洗消毒机卫生要求.
GB 30689-2014 sets the hygienic requirements for automatic washer-disinfectors that use chemical disinfection to reprocess thermolabile flexible endoscopes able to be immersed in water or aqueous solutions, covering their cleaning and disinfection efficacy and their safety.
It defines the equipment, the leakage test and the self-disinfection procedure, gives the NQX designation, and sets performance requirements for leakage testing with alarm and program interruption, flushing, cleaning and rinsing with single-use solutions, disinfectant efficacy (lg 5 reduction of E. coli, S. aureus and P. aeruginosa, lg 4 of Candida albicans, mycobacteria, Aspergillus niger and poliovirus vaccine strain), final rinse water below 10 CFU/100 mL, air filtration of 0.2 µm particles, drying and self-disinfection with a moist-heat A0 value of at least 600.
Mechanical and program requirements cover channel flow verification, discharge of waste liquids and gases, temperature control within ±5 °C, dosing accuracy within ±5%, and 304 stainless steel chambers; electrical safety requirements cover a 1 500 V dielectric test, leakage current limits of 5 mA and 10 mA and a 0.2 Omega protective earth impedance, followed by marking, labelling and packaging.
Clause 5.1 is recommended and the remainder is mandatory. It is a first edition, issued on 22 December 2014 and in force since 1 July 2015. Classification: ICS 11.080, CCS C50. The document runs to 8 pages, delivered complete in English translation.
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Document preview — GB 30689-2014
National Standard of the People's Republic of China
- ICS
- 11.080
- Classification
- C50
Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Standardization Administration of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Designation and model
- 5 Performance requirements
- 6 Mechanical and procedural requirements
- 7 Electrical safety requirements
- 8 Marking, labelling and packaging
3 Terms and definitions
4 Designation and model
5 Performance requirements
6 Mechanical and procedural requirements
7 Electrical safety requirements
8 Marking, labelling and packaging
Foreword
Clause 5.1 of this standard is recommended; the remainder are mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the National Health and Family Planning Commission of the People's Republic of China.
Drafting organisations: National Institute of Environmental Health and Related Product Safety, Chinese Center for Disease Control and Prevention; Shandong Provincial Center for Disease Control and Prevention.
Main drafters: Zhang Liubo, Cui Shuyu, Zhang Jian, Zhao Xiaoli, Zhu Xiaoming, Zhao Binxiu, Zhang Wei, Li Yan.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4064General guide for designing of electrical equipment to satisfy safety requirements
- GB 5749Standards for drinking water quality
- GB 16297Integrated emission standard of air pollutants
- GB 18466Discharge standard of water pollutants for medical organization
Cited by
- GB 28931-2024Hygienic requirements for chlorine dioxide disinfectant generator
- GB 27949-2020General requirements of disinfectant of medical instruments
- GB 28232-2020Hygienic requirements for ozone disinfector
- GB/T 26372-2020Hygienic requirements for glutaraldehyde disinfectants
- WS 507-2016Regulation for cleaning and disinfection technique of flexible endoscope
Similar standards
Editions of GB 30689
| Edition | Title | Revision | Status |
|---|---|---|---|
| GB 30689-2014 | Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | current edition | Current |
This page sells the current edition, GB 30689-2014. Earlier editions are listed for reference only.
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Related Standards
GB 16297-1996 — Integrated emission standard of air pollutants
GB 18466-2005 — Discharge standard of water pollutants for medical organization
GB 4064-1983 — General guide for designing of electrical equipment to satisfy safety requirements
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GB 30689-2014
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