Knee-height overboots, non-sterile

In preparation. This article belongs to the new ProSafe cleanroom line and is not yet available. All technical figures are target specifications for series production, not product commitments. Test reports, conformity documents and sterilisation validations will be supplied with the release of the series.

Aseptically folded overboots, 500 mm high, with two ties and slip-resistant sole. Antistatic, low-linting 60 g/m² fabric, two ties, optionally with ankle elastic; shelf life is designed for 3 years.

Technical details

Article code	P020
Delivery condition	non-sterile
Material	60 g/m² nonwoven laminate, low-linting, antistatic; slip-resistant sole
Dimensions	Height 500 mm; sole length and shaft width set with the approved reference sample
Sizes	One size
Pack size	10 pairs per double bag; 8 outer bags per carton = 80 pairs; carton 43 × 28 × 31 cm
Target environment	ISO Class 4 and 5 cleanrooms and controlled areas; GMP use subject to the operator's own assessment
Supply	on request after release of the series, quote with price and pack size

Features

500 mm high, two ties
Slip-resistant sole
Aseptically folded
Non-sterile

Target specification (design targets)

Target values for series production. They describe what we design material, construction and testing for and are not a commitment for the delivered article. Lot test reports will be supplied with the series.

Basis weight	60 g/m², tolerance ±2 g/m²
Hydrostatic head	minimum 100 mm H₂O
Particle shedding (Helmke drum)	Category I to IEST-RP-CC003
Surface resistivity	typically 10⁷ to 10¹⁰ Ω
Sole slip resistance (ASTM D1894)	Coefficient of friction minimum 0.5
Chemical permeation (ASTM F739)	Carmustine 30 min, thiotepa 60 min; cisplatin, cyclophosphamide, doxorubicin, etoposide, fluorouracil, methotrexate, paclitaxel over 480 min (ASTM F739, design target)
Storage	Dry and cool below 40 °C, away from direct sunlight
Shelf life	3 years from manufacture

Standards framework

PPE Regulation (EU) 2016/425 (PB [6], planned)
IEST-RP-CC003 (particle shedding)
ASTM D1894 (slip resistance)

Notes on use

Overboots are put on seated in the airlock, first the foot across the bench, then the ties around the leg. The conductive ribbon must touch the skin, otherwise it does not conduct. Dispose of after use; single-use product.

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