YY/T 1539-2017 (YY/T1539-2017, YYT 1539-2017, YYT1539-2017) & related versions
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Medical clean bench
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YYT 1539-2017
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YY/T 1539-2017: PDF in English (YYT 1539-2017)
YY/T 1539-2017
Medical clean bench
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Medical clean bench
Published by.2017-05-02
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword I
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 type of clean bench 2
4.1 Classification by airflow pattern 2
4.2 Classification by operation mode 2
5 Requirements 2
5.1 Appearance 2
5.2 Material 2
5.3 Structure 2
5.4 Performance 3
6 Test method 5
6.1 Appearance 5
6.2 Material 5
6.3 Structure 5
6.4 Performance 5
7 labels, tags 12
7.1 Nameplate 12
7.2 Random File 12
8 Packaging, transportation and storage 12
8.1 Packing 12
8.2 Transportation 12
8.3 Storage 13
Appendix A (informative) Inspection Rules 14
A.1 Inspection type 14
A.2 Factory inspection 14
A.3 Type inspection 14
A.4 Installation inspection 14
A.5 Annual Maintenance Inspection 14
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the Beijing Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Wang Huiru, Wang Qiqi, War, Zhang Yuchen.
Medical clean bench
1 Scope
This standard specifies the terms and definitions of clean benches, classification types, materials, structures and performance requirements, test methods, inspection rules,
Requirements for labels, markings, random documents, packaging, shipping and storage.
This standard applies to clean work stations (hereinafter referred to as clean benches) for use by medical institutions.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Clean bench cleanbench
The clean bench is a medical operating system that provides a partial operating ring with a clean rating of ISO 5 (Class 100) or higher.
Box air purification equipment.
Note. Common names for clean benches include clean benches, ultra-clean benches, medical clean benches, and bio-clean benches.
3.2
Vertical flow verticalunidirectionalairflow
The airflow flows from the top to the bottom, and the airflow is perpendicular to the horizontal plane.
3.3
Horizontal flow horizontalunidirectionalairflow
The air flow flows from side to side and the air flow is parallel to the horizontal plane.
3.4
Workspace workingarea
The part of the clean bench that operates.
3.5
Product protection protection
The clean bench prevents airborne contaminants from the outside from entering the work area through the operating port.
3.6
High efficiency filter highefficiencyparticulateair(HEPA)filter
A disposable dry filter with extended/pleated media featuring the following.
---The hard outer shell is filled with pleats;
--- For particulates with a diameter of 0.3μm, the filtration efficiency is not less than 99.99%;
---The clean filter has a maximum pressure drop of 250Pa when operating at rated flow;
--- When the scanning test is carried out with a polydisperse aerosol with a light scattering median size of 0.7 μm and a geometric standard deviation of 2.4, the transmission rate is not exceeded.
Over 0.01%.
3.7
Effective flow rate range theeffectiverangeofvelocity
The flow rate between the lowest and highest values of the clean bench airflow rate specified by the manufacturer.
4 type of clean bench
4.1 Classification by airflow pattern
Can be divided into vertical unidirectional flow and horizontal unidirectional flow.
4.2 Classification by operation mode
Can be divided into single-sided operation and double-sided operation.
5 requirements
5.1 Appearance
5.1.1 There are no obvious scratches, rust spots and indentations on the surface of the box. The surface is smooth and the shape is flat and the sealing part should be strict and reliable.
5.1.2 The text and graphic symbol of the function should be correct, clear, correct and firm.
5.1.3 The welding should be firm and the welding surface should be smooth.
5.2 Materials
5.2.1 All cabinets and decorative materials should be able to withstand normal wear and tear, and can withstand corrosion of gases, liquids, detergents, disinfectants and decontamination operations.
eclipse. The material structure is stable, has sufficient strength, and has fire and moisture resistance.
5.2.2 Work area countertops and sumps (if any) used in clean benches shall be constructed of materials not less than 300 series stainless steel.
5.2.3 The glass used in the clean bench shall be made of safety glass that is optically transparent, clean and disinfected without adversely affecting it.
Its thickness should be no less than 4.8mm.
5.2.4 High-efficiency filter and frame should meet the requirements of temperature, humidity, corrosion resistance and mechanical strength under normal use conditions.
Can't be paper material. Substances that may be released from the filter media should not adversely affect personnel, the environment and equipment. The outer frame is used just some
Made of metal materials of degree and strength.
5.3 Structure
5.3.1 Cabinet
5.3.1.1 The cabinet of the clean bench shall have sufficient strength and rigidity, and the joint shall be sealed. The glass and metal joints of the box must also
Sealed.
5.3.1.2 The surface of the wall in the exposed work area of the clean bench shall be smooth, and the joint of the inner surface shall be sealed.
5.3.1.3 If the air valve and water valve are installed inside the working area, the air valve and the water valve and the pipe shall be sealed.
5.3.1.4 If a power outlet is installed inside the work area, there should be a splash guard. The material should be flame retardant and corrosion resistant.
5.3.1.5 The bottom of the clean bench should be kept at a certain distance from the ground for cleaning.
5.3.1.6 Fan/motor maintenance and disassembly and replacement of high-efficiency filters should be easy to operate. The line entry into the work area is to be sealed, all
The socket needs to provide circuit overload protection. In the area outside the plenum in the cover that can be opened with a simple tool, a permanent sticker is required.
A wiring diagram of all circuit components is required to provide installation instructions for the starting current, operating power, and circuit requirements.
5.3.2 Glass window operation port (if any)
Clean bench manufacturers should require a minimum and maximum opening height for the glazing operator port. Glass windows should be light and easy to open and close
There is no jamming at any position within the range, and there should be no obvious left or right or front and rear swaying, and the sliding should be smooth. Sliding glazing
The construction should ensure that the suspension system can not fall off and cause danger to the operator.
5.3.3 Work area countertop
The table top of the clean bench work area should have sufficient strength and rigidity. There should be no fastening screws on the table surface exposed in the work area. The detachable table
The face or grill should be able to meet the needs of hands-on operation. A clean bench with an air inlet function under the work area table top, the table top structure can be used up and down
Double-layer structure, the work area table top can have grille and orifice plate.
5.3.4 Supporting feet and casters
There should be sufficient stiffness and no exposed threads. It should be able to adjust the level of the clean bench and keep the clean bench stable.
5.3.5 sump (if any)
The sump of the clean bench is used to collect the splashing liquid in the working area and should be closed; the bottom should be equipped with a drain valve.
5.3.6 High efficiency filter
5.3.6.1 The high-efficiency filter should be installed in such a way as to ensure integrity testing of the connection of the filter and its frame.
5.3.6.2 When more than one high efficiency filter is installed in the work area, a device for guiding or reducing eddy current should be designed between each filter.
5.3.7 Motor
The motor used in the clean bench should.
a) It has thermal protection device and can work stably under the condition of 1.15 times rated voltage.
b) It can be adjusted and the control is stable. The speed range allowed by the governor should be the speed range required to achieve proper airflow balance.
5.3.8 Sampling port
The clean bench should be reserved for the sampling port of the high-efficiency filter upstream aerosol concentration test.
5.3.9 Glass window operation port alarm system
For a clean bench with glazing, the audible alarm should be alarmed when the glazing opening height exceeds or falls below the height specified by the manufacturer;
When the opening height returns to the height specified by the manufacturer, the audible alarm should be automatically released.
5.3.10 Wind speed display
The clean bench shall display the real-time airflow rate, which shall have a resolution of at least 0.01 m/s.
5.3.11 Cleanability
The exposed inner surface and other internal surfaces that are susceptible to contamination by spills or spills should be easy to clean.
5.4 Performance
5.4.1 High efficiency filter integrity
The leakage rate of the high-efficiency filter and its frame at the clean bench working area should not exceed 0.01% at any point.
5.4.2 Noise
The clean bench should be no more than 65dB (A) within the effective flow rate set by the manufacturer.
5.4.3 Illuminance
5.4.3.1 The clean bench shall have an average illuminance of not less than 300 lx within the effective flow rate set by the manufacturer.
5.4.3.2 The position of the clean bench illuminator and its accessories shall not interfere with the flow of air.
5.4.4 Vibration
The clean bench shall have a net vibration amplitude of between 10 Hz and 10 kHz within the effective flow rate set by the manufacturer.
5 μm (rms).
5.4.5 Product Protection (Settling bacteria)
Normal operation of the clean bench for 30 minutes, the average number of colonies on the culture dish should not exceed 0.5 CFU.
5.4.6 Air flow rate
5.4.6.1 The average airflow velocity in the clean bench working area should be in the range of 0.20m/s to 0.50m/s.
5.4.6.2 The minimum average airflow rate shall be between ±0.02 m/s of the minimum airflow rate set by the manufacturer; the highest average airflow rate
It should be between ±0.02m/s of the highest airflow rate set by the manufacturer. For subsequent cleanliness, the minimum average airflow rate should be
The minimum airflow rate set by the manufacturer is between ±0.03 m/s; the highest average airflow rate should be the highest airflow set by the manufacturer
The speed is between ±0.03m/s.
5.4.6.3 The difference between the measured value and the average flow rate of each measuring point shall not exceed ±20% or ±0.08m/s (take a larger value).
5.4.7 Airflow mode
5.4.7.1 Vertical flow clean bench
Vertical flow clean bench airflow should be downward, should not produce vortex and upward airflow, and no dead point.
5.4.7.2 Horizontal flow clean bench
The airflow in the working area of the horizontal flow clean bench should be outward, and no vortex and backflow should occur, and there is no dead point.
5.4.8 Cleanliness
The number of dust particles in the clean bench working area ≥0.5μm should be ≤3520/m3, and the number of dust particles ≥5μm should be ≤29/m3.
Note. Clean ISO level 5 (level 100).
5.4.9 Stability
5.4.9.1 The cabinet is resistant to tipping over
When the clean bench is tilted 10° laterally, the clean bench will not fall.
5.4.9.2 Work surface deformation resistance
After loading 23kg in the center of the clean bench, the surface is unloaded and the work surface must not be permanently deformed.
5.4.10 Temperature rise
After the clean bench lighting and fan work and continue to run for 4 hours, the temperature in the center of the work area should not be higher than the ambient temperature outside the clean bench by 8 °C.
5.4.11 UV lamp (if any)
5.4.11.1 The UV lamp should be fixed in the clean bench.
5.4.11.2 Clean station installation interlocking device ensures that the UV lamp can be operated after the glass window is completely closed, and the UV lamp is turned off when the glass window is opened.
5.4.11.3 The front fixed label of the clean bench is clearly displayed. dangerous, pay attention to protect the eyes when the UV lamp is running.
5.4.11.4 When the UV station is equipped with a UV lamp in the work area of the clean bench, measures should be taken to ensure that the lamp and UV lamp cannot be activated at the same time.
5.4.11.5 The location of the UV lamp and its accessories shall not interfere with the flow of air.
5.4.11.6 The UV lamp is installed on the clean bench. The wavelength of 254 nm ultraviolet radiation is on the surface of the working area, and the radiation intensity is not less than 400 mW/m2.
5.4.11.7 The clean bench shall be equipped with a UV light delay opening system, and the horizontal flow clean bench shall be equipped with an ultraviolet protective cover.
5.4.12 Electrical safety
The electrical safety of the clean bench should meet the requirements of GB 4793.1.
6 Test methods
6.1 Appearance
The appearance of the clean bench is tested by eyesight and hand feeling, and the result should meet the requirements of 5.1.
6.2 Materials
The materials used in the clean bench, including stainless steel, glass, filters, etc., shall pass the verification of relevant documents and shall comply with the requirements of 5.2 materials. glass
The thickness is measured with a universal gauge and shall comply with the requirements for glass thickness in 5.2.3.
6.3 Structure
The clean bench structure is tested by eyesight and the results should meet the requirements of 5.3. The sump is visually closed by adding an appropriate amount of water. The result should be
Meets 5.3.5. The alarm system test is carried out by operation and the result should meet the requirements of 5.3.9. Shows wind speed and cleanliness according to 6.4.6
The comparison of the airflow rate of the station shall comply with the requirements for wind speed display in 5.3.10.
6.4 Performance
6.4.1 High efficiency filter integrity
6.4.1.1 Purpose
This test determines the integrity of the clean bench high efficiency filter mounting structure, including the junction of the high efficiency filter and its frame.
6.4.1.2 Reagents
Dioctyl phthalate (DOP) or a comparable liquid can produce the same aerosol size as the DOP aerosol particle size distribution.
Particulate liquids such as polyalphaolefins (PAO), di(2-ethylhexyl) sebacate, polyethylene glycols, and pharmaceutical grade light mineral oils.
6.4.1.3 Instruments
The instruments used in the HEPA filter integrity test are.
--- Linear or logarithmic scale aerosol photometer, the concentration of the filter upstream of the gas stream is 10μg/LDOP (or equivalent
The polydisperse aerosol particles are labeled as 100% and can inspect 0.001% of the same aerosol particle. Photometer should be based on its manufacturer
Instructions for use for calibration.
--- Adjust the pressure of the aerosol generator to a minimum of 140 kPa, using aerosols with DOP or equivalent liquids. generator
The depth at which the nozzle is immersed in the liquid should not exceed 25 mm. Aerosol generator pressure gauge has a maximum range of 0kPa~550kPa,
The resolution and accuracy are 7 kPa. The generator pressure gauge is calibrated by the manufacturer or calibrated according to the manufacturer's instructions.
6.4.1.4 Method
The detection of the scan detection filter is carried out as follows.
a) Adjust the airflow rate of the clean bench to the highest effective flow rate specified by the manufacturer.
b) Remove the filter's diffuser and protective cover (if any). Place the aerosol generator and introduce the aerosol into the clean bench, according to the production
The manufacturer's instructions produce a uniform distribution of high efficiency filter upstream airflow. When the manufacturer does not specify the introduction position of the aerosol,
The way the aerosol is introduced should be such that it is evenly distributed in the airflow of the clean bench.
c) Turn on the aerosol photometer and adjust it according to the manufacturer's instructions.
d) testing the upstream flow of a high-efficiency filter containing aerosols, confirming that the concentration of aerosol at this concentration should be at least equal to
Light scattering intensity produced by 10μg/LDOP.
--- If it is a linear scale photometer (0~100 divisions), adjust the reading to 100;
--- If it is a logarithmic scale photometer, adjust the upstream airflow concentration reading to 1 × 104 of a scale corresponding concentration
On (using the instrument calibration curve).
e) The photometer probe moves no more than 25 mm from the filter surface downstream of the filter and moves at a scan rate of less than 50 mm/s.
The entire downstream side of the probe sweep filter and the edge of each combined filter should have a slight overlap. Around the whole
The periphery of the filter, along the joint between the combined filter and the frame, and the seal around the filter and other components are carefully
an examination.
6.4.1.5 Results
The results of the scanning inspection shall comply with the requirements of 5.4.1.
6.4.2 Noise
6.4.2.1 Purpose
This test is to test the noise of the clean bench when its airflow rate is running at the highest effective flow rate specified by the manufacturer. Testing can be
In a room with normal acoustic conditions, the walls of the room neither absorb nor completely reflect the sound.
6.4.2.2 Instruments
The sound level meter has a measurement range of 50dB~100dB, an accuracy of ±1dB, a resolution of 1dB, and an "A" weighting mode.
6.4.2.3 Method
The noise test is performed as follows.
a) set the sound level meter to "A" weighting mode;
b) Open the fan and illuminator of the clean bench, 300mm horizontally outward in front of the clean bench, 380mm above the work surface
Measure noise.
6.4.2.4 Results
Should meet the requirements of 5.4.2.
6.4.3 Illuminance
6.4.3.1 Purpose
This test is to test the illumination of the clean bench work surface.
6.4.3.2 Instruments
The illuminance meter, with an accuracy of ±10%, should be able to meet the measurement of illumination below 1000 lx and be calibrated according to the manufacturer's instructions.
6.4.3.3 Method
The illuminance test is performed as follows.
a) On the work surface, set the illuminance measurement points along the center line of the two inner side walls of the work surface, and the distance between the measurement points should not exceed
300mm, the minimum distance from the side wall is 150mm;
b) Turn off the lighting of the clean bench and measure the background illumination at the measuring point from one side. The average background illumination should be 110lx
±50lx;
c) Turn on the lighting of the clean bench, start the fan of the clean bench, and measure the illuminance of the clean bench at the measuring point from the side.
6.4.3.4 Results
Should meet the requirements of 5.4.3.
6.4.4 Vibration
6.4.4.1 Purpose
This test is to test the vibration of the clean bench airflow rate at the highest effective flow rate specified by the manufacturer.
6.4.4.2 Instruments
The vibrometer has a minimum reliable reading of 2.5 μm (rms) amplitude and the instrument is calibrated according to the manufacturer's instructions.
6.4.4.3 Method
The vibration test is carried out as follows.
a) Fix the vibrating unit's sensing element to the work surface with clamps, screws, magnets with Vaseline gel film or double-sided tape
Geometric center
b) determining the total vibration amplitude of the clean bench during normal operation;
c) turn off the fan of the clean bench and measure the amplitude of the background vibration;
d) Subtract the background vibration amplitude from the total vibration intensity as the net vibration amplitude of the clean bench.
6.4.4.4 Results
Should meet the requirements of 5.4.4.
6.4.5 Product protection (settlement bacteria)
6.4.5.1 Purpose
When testing the clean bench for normal operation, whether the external contaminants have not entered the working area of the clean bench.
6.4.5.2 Materials and instruments
The materials and instruments for the product protection test are prepared as follows.
a) Petri dish (usually a petri dish of φ90 mm × 15 mm size), soy casein agar medium (TSA). Soy cheese
Protein agar medium (TSA) formula. casein trypsin digest 15g, soy flour papain digest 5g, sodium chloride
5g, agar 15g, purified water 1000mL; take the above ingredients in addition to agar, mix, slightly heat dissolved, adjust the pH to make the sterilization
7.3±0.2, add agar, heat and melt, dispense, sterilize, cool to about 60 ° C, pour about 20mL under aseptic operation requirements
Into a sterile plate (φ90mm). After capping, it is allowed to solidify at room temperature.
b) The interference cylinder (hereinafter referred to as the cylinder) is a cylinder with an outer diameter of 63mm closed at both ends, and the length is determined by the size of the front and rear of the clean bench.
For stainless steel or aluminum. The cylinder is used to simulate the interference of the arm to the clean bench airflow.
6.4.5.3 Method
The microbiological method for product protection testing is carried out as follows.
a) Set the flow rate of the clean bench to the specified minimum value, and the clean bench with glazing opens the glazing to the specified maximum
Value, double-sided operation of the clean bench should open both sides of the glass window to the highest value specified by the manufacturer, clean bench without glass windows
Can be detected directly.
b) Self-purification 30min or the time required by the company.
c) Discharge open petri dishes on the work surface of the clean bench, no less than 14.
d) The cylinder is fixed in the central area of the work surface of the clean bench, and the clean table is extended from the operation port by at least 150 mm, and the axis of the cylinder is higher than
Work surface 70mm.
e) Set up a set of positive and a set of negative control dishes.
f) Cover the Petri dish cover after 30 min of test time.
g) Repeat the test three times.
h) Incubate the culture dish in a 30 ° C ~ 35 ° C incubator. The time is not less than 2d.
i) Repeat the above test procedure by setting the airflow rate of the clean bench to the highest value specified by the manufacturer.
6.4.5.4 Results
Should meet the requirements of 5.4.5.
6.4.6 Airflow rate
6.4.6.1 Purpose
This test tests the flow rate of the gas flow in the clean bench.
6.4.6.2 Instrument
The instruments that test the flow rate of the clean bench are.
--- Temperature-compensated anemometer with an accuracy of ±0.015m/s or ±3% of the indicated value (whichever is greater), according to the manufacturer's instructions
Correction. When the air pressure and temperature at the test point deviate from the standard conditions listed on the anemometer, the manufacturer's manual should be in the anemometer.
The correction factor is corrected.
---Anemometer probe fixture for accurate positioning of anemometer probes without affecting airflow patterns (eg ring clamps and clamps can be used)
use).
6.4.6.3 Method
6.4.6.3.1 Vertical airflow velocity
Set the airflow rate of the clean bench to the lowest value specified by the manufacturer, at a level lower than 100 mm below the flow device in the following manner
The position of the measuring point is determined on the surface, and the vertical flow velocity through the plane is measured at multiple points.
a) The measuring points are equidistantly distributed, and the square grid formed is not more than 150mm×150mm. The test points should have at least 3 rows with the least number of rows.
There should be 7 measurement points.
b) The distance between the test area boundary and the inner wall of the clean bench and......
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| Standard ID | YY/T 1539-2017 (YY/T1539-2017) | | Description (Translated English) | Medical clean bench | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140 | | Word Count Estimation | 18,118 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Beijing Medical Device Inspection Institute | | Administrative Organization | State Food and Drug Administration Beijing Medical Device Quality Supervision and Inspection Center | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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