의료시설의 안전성 시험

Verification services to stability test in medical facilities operating theater

Safety verification in medical facilities has a direct impact on the health of patients, outpatients, and medical staff.

KFTL, as a accredited testing laboratory by KOLAS, conducts verification and performance evaluation of HEPA filters, filtration performance of air purifiers, differential pressure evaluation of isolation facilities, and air cleanliness evaluation of operating theater in medical facilities

1. HEPA filter verification and performance evaluation for medical facilities

Performance Criteria

When tested with fine aerosol (DOP) particles, the removal efficiency shall be maintained at least 99.97%.

Applicable Standards

ASME N510 , ASME AG-1 , KEPIC MH , KS M ISO 14644-3

Test cycle

HEPA filters must be used whose performance has been verified by accredited testing laboratory by KOLAS
+ When the first installation or when static pressure management standards for filtration facilities are exceeded

2. Evaluation of On-site Leak test of Air Purification Facilities

Performance Criteria

When tested with fine aerosol particles, the mechanical removal efficiency at the rated flow rate shall be maintained at least 99.95%.

Applicable Standard

ASME N510, KS I ISO 14644-3

Test Cycle

As a on-site leak test of the air purifier, a periodic test is performed according to the relevant law after the filter is replaced.
+ Industrial Air Purification Facility (24 months)
+ Cleanroom/Clean bench: ISO 1 to 9 grades (24 months)

3. Performance Evaluation of Pressure Difference in Major Facilities in Medical

Performance Criteria

Operating theater: Keep the pressure higher than the surrounding area [to prevent infection from penetrating from outside]
Isolation Room: Keep the pressure lower than the surrounding area [To prevent infection from spreading outside from the isolation room]

Applicable Standards

KS I ISO 14644-3

Test Cycle

As a on-site leak test of the air purifier, a periodic test is performed according to the relevant law after the filter is replaced.
+ Cleanroom/Clean bench: ISO 1 to 9 grades (12 months)

4. Evaluation Service for Air Cleanliness in Medical Facilities

Performance Criteria

Medical facilities where indoor air quality must be managed, such as operating theaters, infection isolation rooms, intensive care units, and newborn rooms, must be secured and maintained at the level of cleanliness prescribed by law or related facilities.

Applicable Standards and Test Cycle

Refer to the “Air Cleanliness Class Certification Service” on the website