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Compliance with ANSI/AAMI PB70 Barrier Level 1-4 Claim

Please see THIS PAGE for sampling plans for PB70 testing

 
  Compliance with ANSI/AAMI PB70 – Barrier Level Claim (1-4)Barrier Level ClaimGown Type & Critical AreasTest Code & Sample AmountUnit Price & Turnaround Time
Level 1: Minimal riskIsolation Gown 4 critical areas: chest, sleeve seam, tie attachment (if there is one) & back Surgical Gown 3 critical areas: chest, sleeve seam, tie attachment (if there is one) Coverall 4 critical areas: chest, sleeve seam, other seams in critical front area, zipper (if there is one)SIT110 Spray Impact Test$96.20 per sample
Sample Amount AQL 4%/RQL 20% sampling plan required for FDA Submission (AATCC42 requires minimum 5 samples); each specimen must be 7 x 13 inches (178 x 330 mm) minimum. See link for additional assistance60 calendar days (No STAT)
Level 2: Low risk & Level 3: Moderate riskIsolation Gown 4 critical areas: chest, sleeve seam, tie attachment (if there is one) & back Surgical Gown 3 critical areas: chest, sleeve seam, tie attachment (if there is one) Coverall 4 critical areas: chest, sleeve seam, other seams in critical front area, zipper (if there is one)SIT110 Spray Impact Test$96.20 per sample
Sample Amount AQL 4%/RQL 20% sampling plan required for FDA Submission (AATCC42 requires minimum 5 samples); each specimen must be 7 x 13 inches (178 x 330 mm) minimum. See link for additional assistance60 calendar days (No STAT)
HPT110 Hydrostatic Pressure Test$93.60 per sample
Sample Amount AQL 4%/RQL 20% sampling plan required for FDA Submission (AATCC127 requires minimum 5 samples); each specimen must be 8 x 8 inches (203 x 203 mm) minimum See link for additional assistance60 calendar days (No STAT)
Level 4: High riskIsolation Gown 4 critical areas: chest, sleeve seam, tie attachment (if there is one) & back Surgical Gown 3 critical areas: chest, sleeve seam, tie attachment (if there is one) Coverall 4 critical areas: chest, sleeve seam, other seams in critical front area, zipper (if there is one)VPT110 Viral Penetration, ASTM F1671$300.30 per test
Sample Amount ASTM F1671 AQL 4%/RQL 20% sampling plan required for FDA Submission (ASTM F1671 requires minimum of 3 specimens); each specimen must be 3 x 3 inches (75 mm x 75 mm) minimum. Include 4 extra samples for setup. See link for additional assistance60 calendar days (No STAT)
VPT705 Viral Penetration, ASTM F1671: Compatibility Test$261.30 per set
Sample Amount Required once per material per site tested. Requires 3 extra specimens per material per site. See link for additional assistance60 calendar days (No STAT)
VPT701 Viral Penetration, ASTM F1671: Setup & preparation, per set$261.30 per set
Sample Amount Setup and preparation, per set Include 4 extra samples for setup. See link for additional assistance60 calendar days (No STAT)
  • Level 1: Minimal risk – to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
  • Level 2: Low risk – to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
  • Level 3: Moderate risk – to be used, for example, during arterial blood draw, inserting an Intravenous (IV)line, in the Emergency Room, or for trauma cases
  • Level 4: High risk – to be used, for example, during long, fluid intense procedures, surgery,  when pathogen resistance is needed or infectious diseases are suspected (non-airborne)

We do not require a formal quote to submit samples, but if you need a quote, you can request a formal quote on your Customer Profile Form. If you require a formal quote you can REQUEST A QUOTE NOW
(Turnaround time to receive a formal quote is 5-7 days)