In hospital operating rooms, H13 high-efficiency air filters are the core components of the air purification system for the clean operating department (CSSD). Their core function is to efficiently intercept particles and microorganisms (such as bacteria, viruses, and fungal spores) in the air. Control the air cleanliness in the surgical area at the level stipulated in the “Technical Specifications for Clean Operating Rooms in Hospitals” (GB 50333-2013) (such as Class 100, Class 1,000, Class 10,000), thereby reducing the risk of surgical site infection (SSI) and ensuring the safety of medical staff and patients. The following is a detailed explanation of the H13 high-efficiency filtration solution specifically designed for operating rooms from dimensions such as scheme design, core components, application logic, and operation and maintenance management.
I. Core Objective of the Scheme Design: To match the cleanliness grade requirements of the operating room
The cleanliness level of hospital operating rooms directly determines the design standard of the H13 high-efficiency filtration system. Different levels correspond to different particle control indicators (classified by particle concentration ≥0.5μm). The H13 filter needs to work in coordination with the air handling unit (AHU), supply and return air system, and air flow organization to achieve “graded purification”.
I. Core Objective of the Scheme Design: To match the cleanliness grade requirements of the operating room
The cleanliness level of hospital operating rooms directly determines the design standard of the H13 high-efficiency filtration system. Different levels correspond to different particle control indicators (classified by particle concentration ≥0.5μm). The H13 filter needs to work in coordination with the air handling unit (AHU), supply and return air system, and air flow organization to achieve “graded purification”.
| Operating room cleanliness grade | Core application scenarios | Particle concentration ≥0.5μm (particles /m³) | The core function of the H13 filter |
| “Level 100” |
Organ transplantation, craniocerebral surgery, cardiac surgery |
≤350 | The terminal supply air is efficiently filtered to directly control the cleanliness of the operating table area |
| “Thousand level” |
Orthopedics, ophthalmology, urology |
≤3500 | Dual filtration at the end and in the return air section maintains the cleanliness and balance of the entire room |
| “Ten thousand level” | General Surgery, Obstetrics and Gynecology | ≤35000 | Combined filtration (primary efficiency + medium efficiency + H13 high efficiency) to control pollution throughout the room |
|
“100,000 level” |
Emergency surgeries and infection surgeries are on standby |
≤350000 | The return air section is efficiently filtered to prevent the spread of pollution |
Ii. System Composition of H13 High-Efficiency Filtration Solution
The H13 filtration system in the operating room is not a single device, but a full-chain purification system of “pre-treatment → medium-efficiency filtration → high-efficiency filtration → air flow control”, with each link working together to achieve the dual goals of “air cleanliness + microbial control”.
1. System architecture: Four-stage filtration + collaborative air flow organization
The air purification system in the operating room gradually purifies the outdoor or indoor return air through a “progressive layer” filtration logic, and finally achieves “clean output at the end” through the H13 high-efficiency filter.
Four-stage filtration process
Primary filtration (G4 grade
Installation location: The fresh air inlet of the air handling unit (AHU).
Core function: Intercept large particle impurities in the air (such as dust, hair, pollen, particle size ≥5μm), protect subsequent medium and high-efficiency filters from rapid clogging, and extend their service life.
Common materials: non-woven fabric, metal mesh, washable or disposable.
Medium-efficiency filtration (F8 grade
Installation location: Inside the air handling unit, after the primary filter.
Core function: Intercept medium-sized particles (particle size ≥1μm, such as fine dust and some mold spores), further purify the air, and reduce the load on the H13 high-efficiency filter.
Common materials: superfine glass fiber, synthetic fiber, for single use only, needs to be replaced regularly.
Sub-high efficiency filtration (H10/H11 grade, optional)
Installation location: The air outlet of the air handling unit or the middle section of the supply air duct.
Core function: As a “pre-protection” for H13 high-efficiency filters, it intercepts particles with a diameter of ≥0.5μm (interception efficiency 90%-99.9%), reduces the deposition of pollutants in H13 filters, and is suitable for Class 100 operating rooms with high cleanliness requirements.
H13 High-efficiency Filtration (Core Link)
Installation location: The “high-efficiency supply air outlet” on the ceiling of the operating room (terminal filtration, directly facing the surgical area) + the “high-efficiency return air outlet” in the return air aisle (to prevent the leakage of contaminated air).
Core function: According to the EN 1822 standard, the interception efficiency for particles ≥0.3μm is ≥99.97%, and it can effectively remove bacteria (such as Staphylococcus aureus, particle size 0.5-1μm), viruses (such as the novel coronavirus, which needs to attach to droplet nuclei larger than 0.5μm), fungal spores and other microbial carriers in the air.
Common forms
High-efficiency supply air outlet (HEPA Diffuser) : Integrated with the ceiling, it adopts a “pleated filter core without partitions” and works in conjunction with a flow distribution plate to achieve uniform air supply, ensuring stable airflow in the operating table area (” clean core area “).
Return air high-efficiency filter: Installed on the inner side of the return air louver in the operating room, it prevents indoor polluted air (such as aerosols generated during surgery) from being directly discharged into the air conditioning system, avoiding cross-contamination.
2. Key supporting components: Ensure the stable operation of the filtration system
The performance of the H13 filter depends on the coordination of the supporting equipment. The core components include:
Air handling unit (AHU) : It provides the mixing, heating, humidification and cooling treatment of fresh air and return air, and offers stable airflow conditions (such as wind speed, temperature and humidity) for H13 filters.
Supply and return air ducts: Made of stainless steel or galvanized steel plates, with smooth inner walls and no dead corners, to prevent dust accumulation and microbial growth inside the ducts, ensuring that the purified air is free from secondary pollution.
Static pressure box: Installed between the high-efficiency supply air outlet and the supply air duct, it balances the air flow pressure and prevents the local load on the H13 filter from being too high due to uneven air velocity.
Differential pressure control system: Real-time monitoring of the pressure difference between the operating room and adjacent areas (such as corridors, clean auxiliary rooms) (requiring the operating room to be “positive pressure” and the infected operating room to be “negative pressure”), and adjusting the supply and return air volume to ensure that clean air does not leak outward and contaminated air does not spread inward.
Iii. Selection and Compliance Requirements of H13 High-Efficiency Filters
The H13 filter used in the operating room is directly related to the safety of medical staff and patients. The selection must strictly follow national standards and medical industry norms. The core indicators are as follows:
Filtration performance index (EN 1822/GB/T 13554 standard)
Particle size interception efficiency: The filtration efficiency for particles ≥0.3μm is ≥99.97% (defined by H13 grade), and it needs to be verified by the “sodium flame method” or “oil mist method”.
Airflow resistance: At the rated air volume, the initial resistance is ≤250Pa (excessive resistance will increase the energy consumption of the air conditioning system and is prone to cause deformation of the filter element).
Dust holding capacity: ≥500g/m² (The higher the dust holding capacity, the longer the service life and the less frequent the replacement).
2. Medical grade compliance requirements
Material safety: The filter element frame should be made of galvanized steel plate or aluminum alloy (with no risk of rust), and the sealant should be medical-grade silicone sealant (free of harmful volatile substances and in compliance with GB 18583 standard) to prevent the release of pollutants from the material and avoid affecting the surgical environment.
Sterility: Before leaving the factory, the filter must undergo gamma-ray sterilization or moist heat sterilization to ensure it is free from microbial contamination (especially suitable for Class 100 sterile operating rooms).
Integrity: It is necessary to pass the “bubble point test” or “diffusion flow test” to ensure that the filter element has no defects such as pinholes or cracks (defects can cause unfiltered air to leak and directly damage the cleanliness).
3. Compatibility indicators
Rated air volume: It should be matched with the supply air volume of the operating room (for example, if the supply air volume of a Class 100 operating room is ≥300m³/h, an H13 high-efficiency supply air outlet with the corresponding air volume should be selected to avoid incomplete filtration due to “a small horse pulling a big cart”).
Installation dimensions: Match the size of the reserved supply air outlet on the operating room ceiling (common sizes are 600×600mm and 800×800mm), and adopt a “flange seal” design to ensure no air leakage during installation.
Iv. System Operation and Maintenance Management: Ensure the continuous and stable performance of H13 filtration
The performance of H13 filters will decline over time (due to dust accumulation causing increased resistance and decreased filtration efficiency), and a standardized operation and maintenance system needs to be established. The core links include:
1. Regular monitoring: Real-time grasp of the filtration status
Resistance monitoring: Through the differential pressure gauge at the high-efficiency air supply outlet, monitor the changes from “initial resistance → operating resistance → final resistance” (when the resistance reaches the final resistance (usually twice the initial resistance, such as 500Pa), the filter element must be replaced).
Cleanliness monitoring: The particle concentration in each area of the operating room is detected monthly through the “particle counter”, and the microbial concentration is detected quarterly through the “airborne bacteria sampler”. If the standards are not met, it is necessary to check whether the H13 filter has leakage or failure.
Integrity test: After the installation of a new filter and each replacement, a “scanning test” should be conducted using an “aerosol photometer” (injecting PAO aerosol upstream of the filter to detect the leakage downstream, with a leakage rate of ≤0.01%).
2. Standardized replacement: Avoid contamination during the replacement process
Replacement cycle: The replacement cycle for H13 filters in conventional operating rooms is 1 to 2 years (for Class 100 operating rooms, due to high load, it is recommended to replace them once a year). If the resistance reaches the final resistance ahead of schedule or the cleanliness does not meet the standard, it must be replaced immediately.
Replacement process
Before the replacement, turn off the air conditioning system in the operating room and disinfect the replacement area (wipe the ceiling with chlorine-containing disinfectant).
The operators wear clean suits, masks and gloves, and use “dust-free operation” to remove the old filter elements. After sealing, they are treated as medical waste.
After removing the packaging of the new filter element, install it immediately to ensure that the sealant adheres completely to the flange and avoid leakage through the gap.
After replacement, start the air conditioning system and run it for 30 minutes before conducting integrity tests and cleanliness checks.
3. Daily maintenance: Extend the service life of the system
Pre-filter maintenance: The primary filter should be cleaned once every 1-2 weeks (washable type) or replaced once (one-time use). The medium-efficiency filter should be replaced every 1 to 3 months to prevent the H13 filter from clogging rapidly due to the failure of the pre-filter.
Air conditioning system cleaning: Every six months, clean and disinfect the surface cooler, humidifier and air ducts of the air handling unit to prevent dust accumulation and microbial growth in the air ducts, which may contaminate the clean air after H13 filtration.
Emergency response: In the event of an infectious surgery (such as COVID-19 or tuberculosis) in the operating room, the return air H13 filter must be replaced immediately after the operation, and the supply and return air systems should be thoroughly disinfected to prevent cross-infection.
V. Trend of Solution Upgrade: Intelligent and Personalized Adaptation
With the development of medical technology, the H13 high-efficiency filtration solution for operating rooms is upgrading towards “precision and intelligence”
Intelligent monitoring upgrade: Integrate “Internet of Things (IoT) sensors” to collect real-time data such as resistance, flow rate, and leakage rate of H13 filters. Through the hospital’s central monitoring platform, achieve “remote early warning” (such as automatically reminding to replace when the resistance approaches the final resistance), avoiding the lag of manual monitoring.
Personalized adaptation: For special operating rooms (such as negative pressure infection operating rooms and laminar flow ward operating rooms), “leak-proof enhanced H13 filters” (with a double-sealed structure) and “antibacterial coated filter elements” (with nano-silver antibacterial agents added to inhibit the growth of microorganisms on the filter element surface) have been developed to further reduce the risk of infection.
Energy-saving optimization: The “Variable Air Volume (VAV) system” is adopted, which automatically adjusts the supply air volume according to the surgical process (such as preoperative preparation, intraoperative, and postoperative cleaning), ensuring cleanliness while reducing air conditioning energy consumption. At the same time, develop “renewable filter elements” (reused through high-temperature sterilization to reduce solid waste generation) to achieve green operation and maintenance.
Summary
The H13 high-efficiency filtration solution dedicated to hospital operating rooms is not merely the application of a single filter, but a comprehensive project that integrates “standard adaptation + system integration + operation and maintenance support”. The core logic is to control the concentration of particles and microorganisms in the surgical environment within a safe threshold through “four-level filtration and hierarchical interception”, “efficient and precise purification at the end”, and “full-process aseptic control”, thereby cutting off the transmission path of surgical site infection from the air level. With the upgrading of intelligent operation and maintenance and material technology, this solution will further enhance the safety and economy of the medical clean environment, providing more reliable protection for both medical staff and patients.
The H13 filtration system in the operating room is not a single device, but a full-chain purification system of “pre-treatment → medium-efficiency filtration → high-efficiency filtration → air flow control”, with each link working together to achieve the dual goals of “air cleanliness + microbial control”.
1. System architecture: Four-stage filtration + collaborative air flow organization
The air purification system in the operating room gradually purifies the outdoor or indoor return air through a “progressive layer” filtration logic, and finally achieves “clean output at the end” through the H13 high-efficiency filter.
Four-stage filtration process
Primary filtration (G4 grade
Installation location: The fresh air inlet of the air handling unit (AHU).
Core function: Intercept large particle impurities in the air (such as dust, hair, pollen, particle size ≥5μm), protect subsequent medium and high-efficiency filters from rapid clogging, and extend their service life.
Common materials: non-woven fabric, metal mesh, washable or disposable.
Medium-efficiency filtration (F8 grade
Installation location: Inside the air handling unit, after the primary filter.
Core function: Intercept medium-sized particles (particle size ≥1μm, such as fine dust and some mold spores), further purify the air, and reduce the load on the H13 high-efficiency filter.
Common materials: superfine glass fiber, synthetic fiber, for single use only, needs to be replaced regularly.
Sub-high efficiency filtration (H10/H11 grade, optional)
Installation location: The air outlet of the air handling unit or the middle section of the supply air duct.
Core function: As a “pre-protection” for H13 high-efficiency filters, it intercepts particles with a diameter of ≥0.5μm (interception efficiency 90%-99.9%), reduces the deposition of pollutants in H13 filters, and is suitable for Class 100 operating rooms with high cleanliness requirements.
H13 High-efficiency Filtration (Core Link)
Installation location: The “high-efficiency supply air outlet” on the ceiling of the operating room (terminal filtration, directly facing the surgical area) + the “high-efficiency return air outlet” in the return air aisle (to prevent the leakage of contaminated air).
Core function: According to the EN 1822 standard, the interception efficiency for particles ≥0.3μm is ≥99.97%, and it can effectively remove bacteria (such as Staphylococcus aureus, particle size 0.5-1μm), viruses (such as the novel coronavirus, which needs to attach to droplet nuclei larger than 0.5μm), fungal spores and other microbial carriers in the air.
Common forms
High-efficiency supply air outlet (HEPA Diffuser) : Integrated with the ceiling, it adopts a “pleated filter core without partitions” and works in conjunction with a flow distribution plate to achieve uniform air supply, ensuring stable airflow in the operating table area (” clean core area “).
Return air high-efficiency filter: Installed on the inner side of the return air louver in the operating room, it prevents indoor polluted air (such as aerosols generated during surgery) from being directly discharged into the air conditioning system, avoiding cross-contamination.
2. Key supporting components: Ensure the stable operation of the filtration system
The performance of the H13 filter depends on the coordination of the supporting equipment. The core components include:
Air handling unit (AHU) : It provides the mixing, heating, humidification and cooling treatment of fresh air and return air, and offers stable airflow conditions (such as wind speed, temperature and humidity) for H13 filters.
Supply and return air ducts: Made of stainless steel or galvanized steel plates, with smooth inner walls and no dead corners, to prevent dust accumulation and microbial growth inside the ducts, ensuring that the purified air is free from secondary pollution.
Static pressure box: Installed between the high-efficiency supply air outlet and the supply air duct, it balances the air flow pressure and prevents the local load on the H13 filter from being too high due to uneven air velocity.
Differential pressure control system: Real-time monitoring of the pressure difference between the operating room and adjacent areas (such as corridors, clean auxiliary rooms) (requiring the operating room to be “positive pressure” and the infected operating room to be “negative pressure”), and adjusting the supply and return air volume to ensure that clean air does not leak outward and contaminated air does not spread inward.
Iii. Selection and Compliance Requirements of H13 High-Efficiency Filters
The H13 filter used in the operating room is directly related to the safety of medical staff and patients. The selection must strictly follow national standards and medical industry norms. The core indicators are as follows:
Filtration performance index (EN 1822/GB/T 13554 standard)
Particle size interception efficiency: The filtration efficiency for particles ≥0.3μm is ≥99.97% (defined by H13 grade), and it needs to be verified by the “sodium flame method” or “oil mist method”.
Airflow resistance: At the rated air volume, the initial resistance is ≤250Pa (excessive resistance will increase the energy consumption of the air conditioning system and is prone to cause deformation of the filter element).
Dust holding capacity: ≥500g/m² (The higher the dust holding capacity, the longer the service life and the less frequent the replacement).
2. Medical grade compliance requirements
Material safety: The filter element frame should be made of galvanized steel plate or aluminum alloy (with no risk of rust), and the sealant should be medical-grade silicone sealant (free of harmful volatile substances and in compliance with GB 18583 standard) to prevent the release of pollutants from the material and avoid affecting the surgical environment.
Sterility: Before leaving the factory, the filter must undergo gamma-ray sterilization or moist heat sterilization to ensure it is free from microbial contamination (especially suitable for Class 100 sterile operating rooms).
Integrity: It is necessary to pass the “bubble point test” or “diffusion flow test” to ensure that the filter element has no defects such as pinholes or cracks (defects can cause unfiltered air to leak and directly damage the cleanliness).
3. Compatibility indicators
Rated air volume: It should be matched with the supply air volume of the operating room (for example, if the supply air volume of a Class 100 operating room is ≥300m³/h, an H13 high-efficiency supply air outlet with the corresponding air volume should be selected to avoid incomplete filtration due to “a small horse pulling a big cart”).
Installation dimensions: Match the size of the reserved supply air outlet on the operating room ceiling (common sizes are 600×600mm and 800×800mm), and adopt a “flange seal” design to ensure no air leakage during installation.
Iv. System Operation and Maintenance Management: Ensure the continuous and stable performance of H13 filtration
The performance of H13 filters will decline over time (due to dust accumulation causing increased resistance and decreased filtration efficiency), and a standardized operation and maintenance system needs to be established. The core links include:
1. Regular monitoring: Real-time grasp of the filtration status
Resistance monitoring: Through the differential pressure gauge at the high-efficiency air supply outlet, monitor the changes from “initial resistance → operating resistance → final resistance” (when the resistance reaches the final resistance (usually twice the initial resistance, such as 500Pa), the filter element must be replaced).
Cleanliness monitoring: The particle concentration in each area of the operating room is detected monthly through the “particle counter”, and the microbial concentration is detected quarterly through the “airborne bacteria sampler”. If the standards are not met, it is necessary to check whether the H13 filter has leakage or failure.
Integrity test: After the installation of a new filter and each replacement, a “scanning test” should be conducted using an “aerosol photometer” (injecting PAO aerosol upstream of the filter to detect the leakage downstream, with a leakage rate of ≤0.01%).
2. Standardized replacement: Avoid contamination during the replacement process
Replacement cycle: The replacement cycle for H13 filters in conventional operating rooms is 1 to 2 years (for Class 100 operating rooms, due to high load, it is recommended to replace them once a year). If the resistance reaches the final resistance ahead of schedule or the cleanliness does not meet the standard, it must be replaced immediately.
Replacement process
Before the replacement, turn off the air conditioning system in the operating room and disinfect the replacement area (wipe the ceiling with chlorine-containing disinfectant).
The operators wear clean suits, masks and gloves, and use “dust-free operation” to remove the old filter elements. After sealing, they are treated as medical waste.
After removing the packaging of the new filter element, install it immediately to ensure that the sealant adheres completely to the flange and avoid leakage through the gap.
After replacement, start the air conditioning system and run it for 30 minutes before conducting integrity tests and cleanliness checks.
3. Daily maintenance: Extend the service life of the system
Pre-filter maintenance: The primary filter should be cleaned once every 1-2 weeks (washable type) or replaced once (one-time use). The medium-efficiency filter should be replaced every 1 to 3 months to prevent the H13 filter from clogging rapidly due to the failure of the pre-filter.
Air conditioning system cleaning: Every six months, clean and disinfect the surface cooler, humidifier and air ducts of the air handling unit to prevent dust accumulation and microbial growth in the air ducts, which may contaminate the clean air after H13 filtration.
Emergency response: In the event of an infectious surgery (such as COVID-19 or tuberculosis) in the operating room, the return air H13 filter must be replaced immediately after the operation, and the supply and return air systems should be thoroughly disinfected to prevent cross-infection.
V. Trend of Solution Upgrade: Intelligent and Personalized Adaptation
With the development of medical technology, the H13 high-efficiency filtration solution for operating rooms is upgrading towards “precision and intelligence”
Intelligent monitoring upgrade: Integrate “Internet of Things (IoT) sensors” to collect real-time data such as resistance, flow rate, and leakage rate of H13 filters. Through the hospital’s central monitoring platform, achieve “remote early warning” (such as automatically reminding to replace when the resistance approaches the final resistance), avoiding the lag of manual monitoring.
Personalized adaptation: For special operating rooms (such as negative pressure infection operating rooms and laminar flow ward operating rooms), “leak-proof enhanced H13 filters” (with a double-sealed structure) and “antibacterial coated filter elements” (with nano-silver antibacterial agents added to inhibit the growth of microorganisms on the filter element surface) have been developed to further reduce the risk of infection.
Energy-saving optimization: The “Variable Air Volume (VAV) system” is adopted, which automatically adjusts the supply air volume according to the surgical process (such as preoperative preparation, intraoperative, and postoperative cleaning), ensuring cleanliness while reducing air conditioning energy consumption. At the same time, develop “renewable filter elements” (reused through high-temperature sterilization to reduce solid waste generation) to achieve green operation and maintenance.
Summary
The H13 high-efficiency filtration solution dedicated to hospital operating rooms is not merely the application of a single filter, but a comprehensive project that integrates “standard adaptation + system integration + operation and maintenance support”. The core logic is to control the concentration of particles and microorganisms in the surgical environment within a safe threshold through “four-level filtration and hierarchical interception”, “efficient and precise purification at the end”, and “full-process aseptic control”, thereby cutting off the transmission path of surgical site infection from the air level. With the upgrading of intelligent operation and maintenance and material technology, this solution will further enhance the safety and economy of the medical clean environment, providing more reliable protection for both medical staff and patients.
