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Sterilization procedure for Non-Breakable Orthopaedic Drill Bit - NBODB®
Sterilization : – Since the drill bits supplied in polyethylene bags are non-sterile,
they should be sterilized before use.
- Prior to sterilization always make sure that the device is clean. Devices
should be sterilized only when they are free of any kind of contamination.
Anyone of the following sterilization methods may be used:
a) Steam, b) Radiation, c) ETO sterilization.
- Always observe the relevant instructions for use of sterilizer. Do not use
damaged instruments.
Steam : - Recommended temperature 134°C, time ≥ 5 minutes, Pressure 2.9 bar.
- The steam must be free of foreign bodies such as rust particles or other
contaminants, Otherwise there is a risk of corrosion, contamination or
formation or deposits on the drill bits. Steam for sterilization purposes must
comply with DIN 58946, section 7 - Requirements for the installation and
operation of large sterilizers and their supply services for sterilization of
medical devices.
- Observe ISO 17665-1:2006 Sterilization of healthcare products – Moist heat –
Part 1:
- Within sterilization containers one or two layers of cloth or paper / non-woven
fleece can be used for wrapping the instrument baskets.
- Single-use paper filters must be replaced after every sterilization cycle; fabric
filters should be replaced after 60 cycles.
- A drying time after sterilization of 15 to 20 minutes is obligatory.
- After drying, the container and the sterilized drill bits should be completely dry.
Any residual moisture or condensed water in the container could lead to the
deposition of a brown colour coating or rust formation on the drill bits.
- The weight of a single batch of instruments in the 1/1 sterilization container
may not exceed 10kg.
- Smaller sterilization containers must be loaded with lighter batches.
Radiation : – Gamma, recommended power: 25kGy, Time: 10 hours
- Observe sterilization standard ISO11137-1:2006 Sterilization of health care products – Radiation – Part 1.
ETO : – Permissible only if other processes are not possible. The time in the chambers varies
according to the temperature.
At 35 degrees, the time is 5 hours
At 200 degrees, the time is 20 minutes
- The specified sterilizing time (exposure time) does not include the time
required to reach the proper temperature for sterilizing, which differs
depending on the quantity, size and packing methods.
- Observe standard ISO 11135-1:2007 Sterilization of health care products – Ethylene Oxide – Part 1:
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