Biomaterials Product catalog 2021 | 3 Manufacturing process MinerOss® X/XP and Mem-Lok® RCM/Pliable The main process steps during manufacture are listed below. Both the product and the production process comply with the required safety standards and requirements of the German regulations, the EU regulations as well as those of the US health authorities (FDA) as well as the safety regulations required for xenogenic processing, including EN ISO 22442-1, EN ISO 22442-2 and EN ISO 22442-3. Mem-Lok® RCM Collagen processed from bovine tendon Washed to remove processing residuals Membrane fabrication Crosslinked Remove unreacted crosslinking agent Sized, packaged and sterilized Every lot tested to meet acceptance criteria Quality control MinerOss® X/XP Receive bone tissue Clean Deproteination through heat treatment Buffer rinse Sized, packaged and sterilized Every lot tested to meet acceptance criteria Quality control Mem-Lok® Pliable Receive harvested porcine peritoneum, collagen-rich tissue Purified to remove non-collagen components Crosslinked Remove unreacted crosslinking agent Sized, packaged and sterilized Every lot tested to meet acceptance criteria Quality control
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