Attribute Category	Key Features	Technical Description
Material & Structure	Medical-Grade Foil Laminate	3-layer construction: PET (outer, 12μm) + Aluminum foil (barrier, 7μm) + PE (inner sealant, 66μm). Provides superior moisture/oxygen barrier (MVTR <0.0003 g/100 in²/24hr; OTR negligible).
Sterilization Compatibility	EO Gas Validated	Compatible with Ethylene Oxide (EO) sterilization (tested per ISO 11140-1). Process indicators change color to confirm sterilization efficacy.
Certification & Compliance	ISO 13485 Certified Manufacturing	Produced under ISO 13485 quality management system. Complies with ISO 11607-1 (packaging for terminally sterilized devices) and EN 868-5.
Seal Integrity	Triple-Seal Design	Reinforced chevron seals + corner tack seals prevent curling/delamination. Passes ASTM F88/F2054 seal strength tests (>3.5N/15mm).
Safety Features	Internal/External Indicators	Dual chemical indicators: External strip confirms exposure to EO; internal strip verifies gas penetration into pouch cavity.
Functional Design	Fibre-Free Peel & Clean Opening	BOP-treated film ensures residue-free peeling; medical-grade paper minimizes particle shedding during aseptic transfer.

Product Specifications

Parameter	Detail	Standard/Value
Physical Properties	Thickness	85±10 μm (3-layer laminate)
Physical Properties	Standard Sizes	90×260mm, 135×255mm (customizable)
Barrier Performance	Moisture Vapor Transmission Rate (MVTR)	<0.0003 g/100 in²/24hr
Barrier Performance	Oxygen Transmission Rate (OTR)	<0.05 cc/m²/day
Sterilization Metrics	EO Sterilization Cycle Tolerance	Validated for 55°C, 60% humidity, 4-6hr exposure
Sterilization Metrics	Shelf Life Post-Sterilization	12 months
Mechanical Strength	Puncture Resistance	16 lbs
Mechanical Strength	Tensile Strength	3,800 psi
Sealing Parameters	Heat Sealing Conditions	Temperature: 300°F-400°F (149°C-204°C); Time: 0.6-4.5 sec; Pressure: 30-70 PSI
Certifications	Regulatory Approvals	ISO 13485, ISO 11607-1, EN 868-5, FDA 21 CFR 177
Packaging & Logistics	Pack Size	200 pouches/box
Packaging & Logistics	MOQ	5,000 pouches