Description
Dimensions (L x W): 200 m x 100 mm
Unit Size: Each
• The STERIKING™ Hot Air rolls are constructed of transparent Polyamide 6 (PA 6) tubing (30 microns). The raw material fulfils the requirements of the FDA regulation 21CFR177.1500 for nylon resins. Recommended sealing temperature for final closing is 200-220° C (418-460° F) with impulse sealer depending on the impulse time.
• Conformity to International Standards - The STERIKING™ Hot Air rolls conform to the international standards: ISO 11607-1:2019 and ISO 11607-2:2019. The products are registered under Class 1 as accessories in compliance with the European Medical Device Directive 93/42/EEC and its amendment 2007/47/EC. To show compliance with MDD the CE mark is printed on the label of the transport carton. STERIKING™ sterilization packages are designed, validated, and manufactured to suit their intended purposes.
• It is recommended that the STERIKING™ products are stored in the original, closed transport carton in dry and clean conditions protected from direct sunlight and excessive moisture.
• If stored according to the instructions for use the shelf life of the STERIKING™ Hot Air rolls is at least 5 years from the date of manufacture.