2.0.1 cleanliness class 100 cleanliness class 100
The number of dust particles greater than or equal to 0.5 μm is greater than 350 particles/m3 (0.35 particles/L) to less than or equal to 3,500 particles/m3 (3.5 particles/L); the number of dust particles greater than or equal to 5 μm is 0.
2.0.2 cleanliness class 1000 Class cleanliness class 1000
The number of dust particles greater than or equal to 0.5μm is greater than 3500 particles/m3 (3.5 particles/L) to less than or equal to 35000 particles/m3 (35 particles/L); the number of dust particles greater than or equal to 5μm is less than or equal to 300 particles/m3 (0.3 particles/L).
2.0.3 Cleanliness class 10000cleanliness class 10000
The number of dust particles greater than or equal to 0.5μm is greater than or equal to 35000 particles/m3 (35 particles/L) to less than or equal to 350000 particles/m3 (350 particles/L); the number of dust particles greater than or equal to 5μm is greater than or equal to 300 particles/m3 (0.3 particles/L) to less than or equal to 350000 particles/m3 (350 particles/L). L) to less than or equal to 3000 grains/m3 (3 grains/L).
2.0.4 Cleanliness class 100000cleanliness class 100000
The number of dust particles greater than or equal to 0.5μm is greater than 350,000 particles/m3 (350 particles/L) to less than or equal to 3,500,000 particles/m3 (3,500 particles/L); the number of dust particles greater than or equal to 5μm is greater than 3,000 particles/m3 (3 particles/L). m3(3 grains/L) to less than or equal to 30,000 grains/m3(30 grains/L).
2.0.5 Cleanliness class 300000cleanliness class 300000
The number of dust particles greater than or equal to 0.5μm is greater than or equal to 3500000 particles/m3 (3500 particles/L) to less than or equal to 10500000 particles/m3 (10500 particles/L); the number of dust particles greater than or equal to 5μm is greater than or equal to 30000 particles/m3 (3000 particles/L). 30,000 grains/m3 (30 grains/L) to less than or equal to 90,000 grains/m3 (90 grains/L).
2.0.6 clean operating departmentclean operating department
By the clean operating room, clean auxiliary rooms and non-clean auxiliary rooms composed of self-contained system of functional areas.
2.0.7 completed state clean room (empty state) as?built clean room
has been built and ready to run, with all the facilities and functions of purification and air-conditioning, but there is no indoor equipment and personnel of the clean room.
2.0.8 pending state clean room (static) at?rest clean room
Indoor purification and air-conditioning facilities and functions are ready, such as process equipment, process equipment has been installed and can be operated, but no staff when the clean room.
2.0.9 operational clean room (dynamic) operational clean room
Normal operation, personnel for normal operation of the clean room.
2.0.10 local clean zone with cleanliness class 100 local clean zone
In a unidirectional flow, in the indoor local area of the establishment of the cleanliness level of 100 class area.
2.0.11 upper class limitupper class limit
The upper limit of the maximum value of the dust concentration of a class.
2.0.12 planktonic bacterial concentration airborne bacterial concentration
Short for planktonic bacterial concentration. Random sampling in the air, the sampling medium is cultured to obtain the number of colonies (CFU), on behalf of the number of airborne bacteria, the number of/m3.
2.0.13 Depositing bacterial concentration depositing bacterial concentration
Abbreviated as the concentration of sedimentation bacteria. With a diameter of 90mm petri dish in the air exposure for 30min, cover the petri dish after the culture of the number of colonies (CFU), on behalf of the number of bacteria in the air can be settled down, a / dish.
2.0.14 Density of surface contaminated bacterial
The number of colonies (CFU) obtained by wiping the surface with a specific method and incubating it as required represents the number of bacteria contaminated on the surface, pcs/cm2.
2.0.15 CFU ( Colong?Forming Units)
An acronym for Cluster Forming Units obtained by culture.
2.0.16Clean?down capability
The time, in minutes, for a clean operating room to recover from a low cleanliness level after contamination (e.g., after a shutdown or after an operation) to an intrinsically static high cleanliness level (e.g., after a power-up or before the start of another operation) under a specified number of air changes.
2.0.15CFU (Colong?Forming Units)
An abbreviation for Cluster Forming Units obtained by culture. p>
2.0.17basic equipmentbasic equipment
Basic facilities associated with the layout and building installation of an operating room for a clean operating room, excluding specialized, mobile, and temporary-use medical instrumentation.
2.0.18 completed acceptance completed acceptance
Construction of the construction party after the construction debugging so that the basic parameters of purification and air conditioning to meet the qualification of the construction of the clean operating room, the quality of the installation of the inspection and approval.
2.0.19Comprehensive performance judgment
The third party has been completed acceptance of the clean surgical department of the level of indicators and technical indicators to carry out comprehensive testing and evaluation.
2.0.20 operating zoneoperating zone
The operating table and its surrounding area need special protection. Class Ⅰ operating room operating area is the operating table on both sides of the edge of at least each extrapolation of 0.9m, at least each end of the extrapolation of 0.4m after (including the operating table) of the region; Ⅱ operating room operating area is the operating table on both sides of the edge of at least each extrapolation of 0.6m, at least each end of each extrapolation of 0.4m after (including the operating table) of the region; Ⅲ operating room operating area is the operating table at least each side of each extrapolation of 0.4m after (including) the area of the operating table. (including the operating table). Class Ⅳ operating room is not divided into surgical area and peripheral area. Class Ⅰ ophthalmology operating room surgical area is not less than 1.2m on each side.
2.0.21 peripheral zone surrounding zone
Clean operating room in addition to the surgical area outside the other areas.