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                 SDI Surgical Diamond Instruments – Cleaning, disinfec on, care, and steriliza on
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REV0116112017EN
6.6 Assembly, Inspec on and Care
The cleaned and disinfected medical device must be vi- sually inspected for cleanliness, completeness, damage and dryness.
• If residues or contamina on are s ll present, the medical device must be manually cleaned and sub- jected to a full cleaning and disinfec on procedure once more.
• Damagedorcorrodedmedicaldevicesmustbewith- drawn from use.
• Joints,threadsandglidesurfacesmustbelubricated locally with instrument oil or special grease.
• A erwards, a func onal check must be carried out.
 NOTE: The oil used for this purpose must be suitable for the subsequent steriliza on procedure (silicone- free and para n- or white oil- based).
6. 7 Packaging Systems
Only standardized and approved packaging materials or systems may be used (EN 868 Parts 2-10, EN ISO 11607 Parts 1 + 2, DIN 58953).
6.8 Steriliza on
The procedure must be selected taking the respec ve applicable na onal requirements into account and in consulta on with the device manufacturers.
The following steriliza on methods have been validat- ed and approved for SDI-medical products,
Steam steriliza on in the frac onated prevacuum pro- cedure
The medical device must be sterilized in its fully assem- bled state using a frac onated prevacuum procedure (DIN EN ISO 17665- 1) at 134 - 137 °C with a minimum exposure  me of 4 minutes and maximum of 18 min- utes. These procedures are only suitable for thermo- stable Instruments.
 NOTE: Greased components must be disassembled for steriliza on, so that steam penetra on is en- sured.

















































































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