Please see THIS PAGE for sampling plans for PB70 testing
Not Looking to Comply with ANSI/AAMI PB70 nor Claim a Level | Gown Type & Critical Areas | Test Code & Sample Amount | Turnaround Time | Test Code & Sample Amount | Turnaround Time | |
Isolation Gown
4 critical areas: chest, sleeve seam, tie attachment (if there is one) & back | SBP110 Synthetic Blood Penetration, ASTM F1670 | OR | VPT110 Viral Penetration, ASTM F1671; | |||
| VPT705 Viral Penetration, ASTM F1671: Compatibility Test; | ||||||
| SBP701 Synthetic Blood Penetration, ASTM F1670: Setup & prep. (set 32) | VPT701 Vial Penetration, ASTM F1671: Setup and preparation, per set | |||||
Sample Amount ASTM F1670 AQL 4%/RQL 20% sampling plan required for FDA Submission (ASTM F1670 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. | 60 calendar days (No STAT) | Sample Amount VPT110: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. VPT705: ASTM F1671: Compatibility Test. Required once per material per site tested. Requires 3 extra specimens per material per site. VPT701: ASTM F1671: Setup and preparation, per set | 60 calendar days (No STAT) | |||
| HPT110 Hydrostatic Pressure Test | HPT110 Hydrostatic Pressure Test | |||||
| 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 | 60 calendar days (No STAT) | 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 | 60 calendar days (No STAT) | |||
| SIT110 Spray Impact Test | SIT110 Spray Impact Test | |||||
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. | 60 calendar days (No STAT) | 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. | 60 calendar days (No STAT) | |||
Surgical Gown
3 critical areas: chest, sleeve seam, tie attachment (if there is one) | SBP110 Synthetic Blood Penetration, ASTM F1670 | OR | VPT110 Viral Penetration, ASTM F1671; | |||
| VPT705 Viral Penetration, ASTM F1671: Compatibility Test; | ||||||
| SBP701 Synthetic Blood Penetration, ASTM F1670: Setup & prep. (set 32) | VPT701 Vial Penetration, ASTM F1671: Setup and preparation, per set | |||||
Sample Amount ASTM F1670 AQL 4%/RQL 20% sampling plan required for FDA Submission (ASTM F1670 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. | 60 calendar days (No STAT) | Sample Amount VPT110: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. VPT705: ASTM F1671: Compatibility Test. Required once per material per site tested. Requires 3 extra specimens per material per site. VPT701: ASTM F1671: Setup and preparation, per set | 60 calendar days (No STAT) | |||
| HPT110 Hydrostatic Pressure Test | HPT110 Hydrostatic Pressure Test | |||||
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 | 60 calendar days (No STAT) | 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 | 60 calendar days (No STAT) | |||
| SIT110 Spray Impact Test | SIT110 Spray Impact Test | |||||
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. | 60 calendar days (No STAT) | 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. | 60 calendar days (No STAT) | |||
Coverall
4 critical areas: chest, sleeve seam, other seams in critical front area, zipper (if there is one) | SBP110 Synthetic Blood Penetration, ASTM F1670 | OR | VPT110 Viral Penetration, ASTM F1671; | |||
| VPT705 Viral Penetration, ASTM F1671: Compatibility Test; | ||||||
| SBP701 Synthetic Blood Penetration, ASTM F1670: Setup & prep. (set 32) | VPT701 Vial Penetration, ASTM F1671: Setup and preparation, per set | |||||
Sample Amount ASTM F1670 AQL 4%/RQL 20% sampling plan required for FDA Submission (ASTM F1670 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. | 60 calendar days (No STAT) | Sample AmountVPT110: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. VPT705: ASTM F1671: Compatibility Test. Required once per material per site tested. Requires 3 extra specimens per material per site. VPT701: ASTM F1671: Setup and preparation, per set | 60 calendar days (No STAT) | |||
| HPT110 Hydrostatic Pressure Test | HPT110 Hydrostatic Pressure Test | |||||
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 | 60 calendar days (No STAT) | 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 | ||||
| SIT110 Spray Impact Test | SIT110 Spray Impact Test | |||||
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. | 60 calendar days (No STAT) | 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. | 60 calendar days (No STAT) | |||
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 are new to Nelson Labs you can REQUEST A QUOTE NOW
(Turnaround time to receive a formal quote is 5-7 days)
