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 |
Clean operating room grade standards: (empty or static)
| grade | Maximum average concentration of settled (floating) bacteria | Maximum surface contamination density | Air cleanliness level | ||
| Operating room area | Surrounding area | Operating room area | Surrounding area | ||
| I | 0.2 pieces/30min φ 90m (5 pieces/m3) | 0.4 pieces/30min φ 90mL (10 pieces/m3) | 5pcs/cm | Level 100 | Level 1000 |
| II | 0.75 pieces/30min φ 90m (25 pieces/m3) | 1.5 pieces/30min φ 90 mm (50 pieces/m3) | 25pcs/cm | Level 1000 | Level 10000 |
| III | 2 pieces/30min φ 90m (75 pieces/m3) | 4 pieces/30min φ 90 mm (150 pieces/m3) | 25pcs/cm | Level 10000 | Level 100000 |
| IV | 5 pieces/30min, φ90 (175 pieces/m3) | 25pcs/cm2 | Level 300000 | ||
Note:
1. 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;
2. Applicable surgical tips
Level 1 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) |
The surgical area of a first-level operating room refers to the area including the operating table after the two sides of the operating table are extended at least 0.9 meters and the two ends are extended at least 0.4 meters (each side of the ophthalmic operating room is not less than 1.2 meters), and the other areas in the room are the surrounding areas:
The surgical area of a second-level operating room refers to the area including the operating table after the two sides of the operating table are extended at least 0.6 meters and the two ends are extended at least 0.4 meters, and the other areas in the room are the surrounding areas:
The surgical area of a third-level operating room refers to the area including the operating table after the four sides of the operating table are extended at least 0.4 meters, and the other areas in the room are the surrounding areas:
The fourth-level operating room does not distinguish between the surgical area and the surrounding area,
