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Hospital Operating Room Cleanliness Level Standards
General Clean Operating Room Grade Standards
| Grade | Applicable Surgical Contents |
|---|---|
| I | Special clean operating room - Aseptic surgery such as joint replacement, organ transplantation, brain surgery, ophthalmology and cardiac surgery |
| II | Standard clean operating room - Chest surgery, plastic surgery, urology, hepatobiliary and pancreatic surgery, bone surgery, egg retrieval and a type of aseptic surgery in general surgery |
| III | General clean operating room - General surgery, (excluding a type of incision surgery), obstetrics and gynecology, etc. |
| IV | Quasi-clean operating room - Anorectal surgery and contamination surgery, etc. |
Classification of Main Clean Auxiliary Rooms
| Grade | Room Name |
|---|---|
| I | Special laboratories that require aseptic operation |
| II | Extracorporeal circulation perfusion preparation room |
| III | Scrub room, disinfection preparation room, pre-anesthesia room, storage room for disposable items, sterile dressings and precision instruments, nurse station, clean corridor, intensive care unit (ICU) |
| IV | Recovery room (anesthesia awakening), dressing room (second shift), clean corridor |
Operating Room Cleanliness Grade Standards (Empty or Static)
| Grade | Maximum Average Concentration of Settled (Floating) Bacteria | Maximum Surface Contamination Density | Air Cleanliness Level |
|---|---|---|---|
| I | 0.2 pieces/30min φ 90m (5 pieces/m3) (Operating room area) 0.4 pieces/30min φ 90mL (10 pieces/m3) (Surrounding area) | 5pcs/cm | Level 100 (Operating room area) Level 1000 (Surrounding area) |
| II | 0.75 pieces/30min φ 90m (25 pieces/m3) (Operating room area) 1.5 pieces/30min φ 90 mm (50 pieces/m3) (Surrounding area) | 25pcs/cm | Level 1000 (Operating room area) Level 10000 (Surrounding area) |
| III | 2 pieces/30min φ 90m (75 pieces/m3) (Operating room area) 4 pieces/30min φ 90 mm (150 pieces/m3) (Surrounding area) | 25pcs/cm | Level 10000 (Operating room area) Level 100000 (Surrounding area) |
| IV | 5 pieces/30min, φ90 (175 pieces/m3) | 25pcs/cm2 | Level 300000 |
Note:
- The maximum average bacterial concentration of the floating method uses bracketed values. The bacterial concentration is the direct measured result, not the result of the conversion between the sedimentation method and the floating method.
- Applicable surgical tips:
- Level I: Joint replacement surgery, organ transplant surgery and sterile surgery in operating rooms such as brain surgery, cardiac surgery and ophthalmology
- Level Ⅱ: Sterile surgery with 2-type incisions in brain surgery, plastic surgery, urology, hepatobiliary and pancreatic surgery, orthopedics and general surgery
- Level III: General surgery (excluding 2-type incision surgery), obstetrics and gynecology, etc.
- Level IV: Anorectal surgery, etc.
Main Cleaning Auxiliary Grade Standards (Empty or Static)
| Grade | Maximum Bacterial Concentration by Sedimentation Method (Floating Method) | Maximum Surface Contamination Density (pcs/cm2) | Air Cleanliness Level |
|---|---|---|---|
| I | Local: 0.2/30min; φ90 plate (5/m3); Other areas: 0.4/30min; φ90 plate (10/m3); | 5 | Local: Level 100 (iso5) Other areas: Level 1000 (iso6) |
| II | 1.5 pieces/30min, φ90 dish (50 pieces/m3) | 5 | Level 10000 (iso7) |
| III | 4 pieces/30min, φ90 dish (150 pieces/m3) | 5 | Level 100000 (iso8) |
| IV | 5 pieces/30min, φ90 dish (175 pieces/m3) | 5 | Level 300000 (iso9) |
Operating Room Area Classification
Level I Operating Room
The surgical area includes the operating table after extending at least 0.9 meters on both sides and at least 0.4 meters at both ends (each side of the ophthalmic operating room is not less than 1.2 meters). Other areas in the room are surrounding areas.
Level II Operating Room
The surgical area includes the operating table after extending at least 0.6 meters on both sides and at least 0.4 meters at both ends. Other areas in the room are surrounding areas.
Level III Operating Room
The surgical area includes the operating table after extending at least 0.4 meters on all four sides. Other areas in the room are surrounding areas.
Level IV Operating Room
Does not distinguish between the surgical area and the surrounding area.
