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GB 30689-2014: Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
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Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
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GB 30689-2014
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Basic data | Standard ID | GB 30689-2014 (GB30689-2014) | | Description (Translated English) | Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes | | Sector / Industry | National Standard | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.080 | | Word Count Estimation | 9,916 | | Date of Issue | 12/12/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 191; GB 4064; GB 5749; GB 16297; GB 18466 | | Regulation (derived from) | National Standards Bulletin 2014 No. 30 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Standard specifies the classification principles named endoscopic cleaning disinfection machine performance requirements, mechanical and procedural requirements, electrical safety requirements and packaging, transportation and storage requirements. T | GB 30689-2014: Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
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Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ICS 11.080
C50
National Standards of People's Republic of China
Automatic endoscope cleaning and disinfecting machines hygiene requirements
Issued on. 2014-12-22
2015-07-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
5.1 This standard is recommended, the rest are mandatory.
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is proposed and managed by the National Health and Family Planning Commission People's Republic of China.
This standard was drafted. Chinese Center for Disease Control Environmental Health and Related Product Safety, Shandong Province Center for Disease Control and Prevention.
The main drafters. Zhang stream wave, Cuishu Yu, Zhang Jian, Zhao Xiaoli, Zhu Xiaoming, Zhao Binxiu, Zhang, Li Yan.
Automatic endoscope cleaning and disinfecting machines hygiene requirements
1 Scope
This standard specifies the endoscope cleaning and disinfecting machines nomenclature classification principles, performance requirements, mechanical and procedural requirements, electrical safety requirements and packaging,
Transportation and storage requirements.
This standard applies to the cleaning of endoscopic cleaning and disinfection efficacy and safety of disinfection machines.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4064 Electrical equipment safety design guidelines
GB 5749 drinking water health standards
GB 16297 Air Pollutant Emission Standards
GB 18466 medical institutions water pollutant discharge standards
Disinfection technical specifications (2002 edition) Ministry of Health
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Automatic endoscope cleaning and disinfecting machines autowasher-disinfectorforendoscopic
Chemical disinfection of endoscopic cleaning and disinfection of automation equipment. This standard endoscopic cleaning and disinfecting machines are available
Able to handle immersed in water or aqueous solutions of non-heat-resistant flexible endoscopy. Some can not handle the submerged part of the instrument in accordance with the instrument manufacturer
's Operating requirements.
3.2
Leak testing leakagetest
Confirm endoscopic wrapped inside pipe surface and whether the integrity of the testing, maintaining a low positive pressure test.
3.3
Own disinfection procedures self-disinfectantprocedure
Procedure of the automatic controller, in the no-load washer use water for cleaning, disinfecting and rinsing equipment used and the
All aqueous liquid delivery system in contact with the cavity, sink and other components to sterilize.
4 Name and type
4.1 Name
Automatic endoscope cleaning and disinfecting machines.
4.2 Naming
Endoscopy
Q X-
Washer disinfector
Extension (by the manufacturer according to the type of disinfectant used
And each cleaning endoscopic quantity determined)
5 Performance Requirements
5.1 leak test system
5.1.1 Leak test applies when endoscopic waterproof performance. Requirements Testing Procedures shall, prior to endoscopic automatic washing machine disinfection liquid contact within
carry out.
5.1.2 automatic endoscope cleaning and disinfecting machines such as endoscopy to detect leakage, should provide a visual and audible alarm signal display leak test failure
Defeat, should automatically interrupt automatic controller while the program is running.
5.2 Cleaning System
5.2.1 Prepare
Automatic endoscope cleaning and disinfecting all surfaces shall be capable of endoscopic (inner or outer surface) for cleaning. Endoscopy of a manufacturer's instructions
These can not be immersed in water or aqueous solutions of instrument components (such as electrical connectors), should be in accordance with the instrument manufacturer's instructions, the automatic endoscope cleaning and disinfecting machines
Avoid these components when immersed for processing.
5.2.2 Flush
Automatic endoscope cleaning and disinfecting machines should be able to inner surface and an outer surface of the endoscope are necessary flushing. Wash water or rinse solution each
Processing times during or after each treatment discharge can not be reused.
5.2.3 Cleaning
Automatic endoscope cleaning and disinfecting machines manufacturer shall specify the used cleaning fluid. In the cleaning solution per each treatment process or the rear
Place, can not be reused. Cleaning phase response over the temperature of the solution is monitored to ensure that the temperature of the washing liquid temperature control in the range specified by the manufacturer
Around inside.
5.2.4 rinse
Rinse should ensure that the concentration of residual liquids (chemicals and pollutants treatment include microbiological contaminants) is reduced to not affect the disinfection effect
The level of fruit. It should ensure that the reaction does not occur between the chemical substances used, suspended or residual contamination does not react with the disinfectant. drift
Water quality of the automatic endoscope cleaning and disinfecting machine manufacturer, in compliance with the provisions of GB 5749.
5.3 Disinfection
5.3.1 Disinfectants
Endoscopic automatic washing machine manufacturer disinfectants used should be specified and choose disinfectant should comply with the relevant health standards. Disinfectants
It may be a liquid, or may be gaseous. In automatic endoscope cleaning and disinfecting machines sterilization manual describes the shortest time, the lowest concentration and minimum temperatures
Under all should meet the following requirements. lg5 can kill E. coli, Staphylococcus aureus and Pseudomonas aeruginosa bacteria, can kill lg4 white rosary
Bacteria, mycobacteria, Aspergillus niger and poliovirus vaccine strains; within a certain period of time disinfectant can kill lg5 subtilis
Variant spores. These data may be provided by the manufacturer of disinfectant, but endoscopic cleaning and disinfecting machine automatic production of chemical disinfection should also factor authenticators
Meets the requirement.
Disposable disinfectant should monitor the concentration of each batch. After repeated use of disinfectants should be measured once formulated concentration, followed by
Monitoring frequency should follow product instructions executed; product brochures are not indicated, the number of endoscopic disinfection reach half the prescribed amount, it should be in every
Article endoscope disinfection before measurement. EOW shall, before each use, the use of the site oxidizing water at the outlet, respectively,
Determination of pH and chlorine concentration.
5.3.2 Temperature
Disinfecting solution throughout the sterilization stage temperature should be monitored to ensure that its temperature is controlled within the range specified by the manufacturer of the disinfectant of.
5.3.3 Monitoring Program
Program monitored by the automatic controller of each phase of operation should include a confirmation procedure to confirm that the concentration of disinfectant, temperature and
Contact time.
5.3.4 Disinfection
The best solution was sterilized after each use of the program ends emissions, emissions should be reused in a limited number of times. So that each repetition
Use should pay attention to the effectiveness of the disinfectant, disinfectant have to kill microorganisms to ensure performance.
Disinfection in endoscopy simulation test shall demonstrate the minimum self-cleaning disinfection time disinfection manual describes the lowest concentration and minimum temperatures
All should meet the following requirements. Removal lg5 Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa bacteria, removing lg4 Candida albicans, M.
Bacillus, Aspergillus and poliovirus vaccine strain to remove lg3 of Bacillus subtilis.
Detection disinfection compliance "disinfection technical specifications" (2002 edition) requirements.
5.4 Finally rinse
Automatic endoscope cleaning and disinfecting machines If the supplied water treatment equipment should make the water physical and chemical indicators have reached the purified water requirements and must not be stored
Use only. Purified water should meet the requirements of GB 5749. It should ensure that the total number of bacteria is less than 10CFU/100mL.
5.5 rinse water discharge
5.5.1 automatic endoscope cleaning and disinfecting machine should rinse water discharge device.
The residue inside the pipe instrument 5.5.2 rinse water by filtration blowing gas. Air filters should be able to remove more than 99.99% of 0.2μm
Particles. The outer surface of the instrument after completion of the automatic program should not contain too much water, you do not need to dry before using it again.
5.6 Drying
Endoscopic cleaning and disinfection procedures should be dried, or indicated in the specification instruments and equipment should be in accordance pipeline before storing device manufacturers
Drying requirements.
5.7 disinfection itself
5.7.1 should have their own automatic cleaning endoscopic disinfection procedures to ensure that contaminants do not accumulate disinfection equipment, and equipment for maintenance, Victoria
After repair or test performed using interrupts itself disinfection.
5.7.2 itself disinfection procedures should ensure endoscopic cleaning and disinfection, endoscopic water or rinse solution of the contact phase using an automatic cleaning and disinfection
All cavity machines, pipe and tank for disinfection.
5.7.3 The manufacturer shall provide itself disinfection program can handle the details and indicate whether to include part of the water treatment equipment.
5.7.4 automatic endoscope cleaning and disinfecting machines sterilization procedure itself should meet the following conditions.
a) operate in automatic controller;
b) selected by the user program;
c) the cavity can be sterilized and liquid transport systems;
d) should alert their own sterilization program should be run at no-load condition;
e) thermal disinfection process itself should adopt moist heat sterilization, heat sterilization A0 value of at least 600;
A0 value calculation which meets the following steps.
1) at 80 ℃ moist heat disinfection time in seconds equivalent time, take the Z value is 10 ℃;
2) confirmed that the measured temperature of the heating temperature of the water for the first time reached 65 ℃, and then record the 10s intervals
The temperature inside the t (℃) until the end of the program;
3) calculated by equation (1) increase the amount of each measured ΔA0.
ΔA0 = 10 [(t-80)/10] × 10 (1)
Where.
t --- each 10s interval temperature of the lowest temperature, in degrees Celsius (℃);
4) A0 is all ΔA0 totals.
If the water temperature is not lower than the value of the relevant provisions of this part of the standard value (such as cleaning cabinet for surgical instruments treated as 600s) considered to reach
Satisfactory test results.
6 mechanical and procedural requirements
6.1 Cleaning System
6.1.1 Requirements
Cleaning, disinfecting and rinsing, the cleaning system should ensure that all the liquid to circulate in cleaning and disinfection of the pipeline and the cavity.
6.1.2 Precautions
The manufacturer shall specify each tube or piping system the maximum and minimum flow rate at design time and the highest pressure. When processing medical devices,
Pressure and flow rate should not exceed the maximum specified by the manufacturer of medical devices.
Confirm 6.1.3 Automatic controller device pipeline for water injection
6.1.3.1 automatic endoscope cleaning and disinfecting machine manufacturers respond to the maximum allowable flow rate of each pipe (such as changes in the flow of capacity pressures, ratios, etc.)
Make provisions under the scope of the program does not affect the results.
6.1.3.2 When a device on the pipeline did not automatically cleansing and disinfection of endoscopic automatic controller connected, it should alert message.
6.1.3.3 In any case the controller should automatically recognize the role of various liquids in line with the set time, verification report should each stage
confirm.
6.1.3.4 When an interface to when two or more liquid supply pipes, the manufacturer shall provide evidence to confirm that at the same supply pressure flow
To each pipe through a liquid line with cleaning, disinfecting and rinsing requirements.
6.2 ventilation and drainage systems
Automatic endoscope cleaning and disinfecting machine design and production should ensure that the waste gas emissions. Emission concentration of various chemical liquids should be consistent
GB 18466 provisions, the concentration of harmful gases should also comply with the provisions of GB 16297.
6.3 Temperature Control
The manufacturer shall specify for each stage of the operating temperature. Should ensure that all stages of temperature control between the specified temperature ± 5 ℃. exceed
Should be alert.
6.4 Quantitative Systems
Each independent chemical liquids in separate containers for containing the control should be provided to ensure that the preset dose consistent with actual use. Chemistry
Liquid dosage error value should be less than ± 5% of the set value.
6.5 Mechanical Requirements
6.5.1 cavities and pipes should be used for 304 stainless steel or other chemically stable rust-proof material.
6.5.2 disinfection should have good sealing performance under normal operating conditions, without water seepage leakage phenomenon.
7 electrical safety requirements
7.1 electrical design shall comply with the provisions of GB 4064.
It should be able to withstand the power network between 7.2 and housing AC voltage 1500V, 50Hz, sine wave test voltage withstand test lasted 1min, and
No flashover or breakdown phenomenon.
7.3 Earth leakage current normal operating conditions should not exceed 5mA, under a single fault condition should be less than 10mA.
7.4 Mains power protection and the protected ground of all possible impedance grounding between the accessible metal parts shall not exceed 0.2Ω.
8 Marking, labeling, packaging
8.1 mark, label
8.1.1 Each automatic endoscope cleaning at least the following marks on disinfection.
--- Manufacturer's name, trademark and address;
--- Product name and model;
--- Supply voltage, frequency, input power;
--- Date of manufacture and production number;
--- Total weight (kg);
--- Product Registration Number and the implementation of standards.
8.1.2 shall be marked with at least the inspection certificate.
--- Name of the manufacturer;
--- Product name and model;
--- Date of inspection;
--- Code inspector.
8.1.3 at least shall be marked on the outside of the box.
--- Manufacturer's name and address;
--- Product name and model;
--- Date of manufacture and production number;
--- Volume (length × width × height);
--- Gross Weight (kg);
--- Product Registration Number and the implementation of standards;
--- Necessary Pictorial signs should be consistent GB/T 191 provisions.
8.2 Packaging
8.2.1 Each disinfection application of neutral plastic film covering and the box secured to prevent shifting of the transport process.
8.2.2 should be accompanied within each sterilizer box using the specification and inspection certificates and the like.
8.2.3 Application of wooden packaging by order or contract packaging.
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