FDA rekonèt direktiv ki soti nan American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, ki presize tès ak rezilta ki nesesè pou verifye ak valide ròb sa a bay nivo pwoteksyon espesifik.
AAMI PB70:2012 detay metòd tès espesifik ak kritè pase yo nan lòd yo make yon ròb izolasyon kòm AAMI 1, 2, 3, oswa 4 rated. Yon rezime tès obligatwa yo nan lis ki anba a:
Nivo AAMI | Metòd tès | Estanda |
1 | AATCC-42: Water Resistance: Impact Penetration | Mwens pase oswa egal a 4.5g |
2 | AATCC-42: Water Resistance: Impact Penetration AATCC-127: Water Resistance: Hydrostatic Pressure | Mwens pase oswa egal a 1.0g Pi gran pase oswa egal a 20cm |
3 | AATCC-42: Water Resistance: Impact Penetration AATCC-127: Water Resistance: Hydrostatic Pressure | Mwens pase oswa egal a 1.0g Pi gwo pase oswa egal a 50cm |
4 | ASTM F1671: Viral pénétration | Pase |
Konpayi Wuhan Youfu gen rapò PP plis PE, SMS, CPE izolasyon AAMI. Tanpri, ezite kontakte nou si ou enterese tcheke yo, nou pral voye ba ou yon fwa resevwa kontak ou!
