Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified

Place of Origin	Guangdong,China
Brand Name	Bright Pack
Certification	patent for invention、BRC、GRS
Model Number	B010

Product Details

Sealing Method:

Zipper, Zipper Lock, Or Heat Seal

Pattern Customization:

Support

Advantage:

Eco-friendly

Heat Seal:

Yes

Colors:

Customized Colors

Printing Method:

Digital Or Gavure

Pattern Artwork:

Custom

Shape:

Customizable

Artwork:

AI,PDF, PSD Etc

Keyword:

Food Packaging Bag

Bpa Free:

Yes

Print:

Good

Closure Type:

Self-Standing Zipper

Property:

Waterproof

Smell Proof:

Yes

Highlight:

sterile foil pouch medical-grade

EO gas compatible foil pouch

ISO 13485 certified sterile pouch

Payment & Shipping Terms

Minimum Order Quantity

100pcs

Price

￥0.02-0.11/pcs

Packaging Details

Export special carton packaging and plate

Delivery Time

11-13 work days

Payment Terms

T/T,Western Union

Supply Ability

200000pcs/day

Product Description

Medical-Grade Sterile Foil Pouch | EO Gas Compatible + ISO 13485 Certified

Product Attributes

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