The STERIKING® See-through Self-sealable pouches are intended for use as packing material in sterilization by steam, ethylene oxide gas, or by formaldehyde in. The common steam sterilization conditions are 3 minutes at 134º C or 15 minutes at 121º C. The products are for single use only.

The STERIKING® See-Through packages are constructed of medical grade paper (70g/m2) that is heat-sealed together with a multiply PET/PP-plastic laminate (12/40 microns).

Certifications

• The products are registered by FDA under 510(k) Premarket Submission Nos.: K803293 and K953776.
• The STERIKING® See-Through range of peel packages conform to the international product standards and norms: ISO 11607-1:2006, ISO 11607-2:2006 and EN 868-5:2009.
• 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.
• Wipak Oy is certified to ISO 9001:2008; ISO 13485:2003, ISO 14001: 2004; OHSAS 18001: 2007 and ISO 22000: 2005.

Sizes

Refer to downloads.

• The paper is a high-weight medical grade with improved barrier and water repellent properties
• The controlled pore size provides for effective air evacuation and steam penetration.
• The specially treated surface facilitates strong sealing against the film but allows fiber-free peeling off without breaks.
• The paper conforms to the requirements of the European EN 868-3:2009 and it is free from dirt, toxic substances and odor.