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6.5.1 Procedure
1. Pack the device in a packaging approved for steam sterilization. If the irrigation
ring has be removed before reprocessing, the microsaw and the irrigation ring
should be packed in two different sterilization pouches. If the irrigation ring is left
on the microsaw during cleaning/decontamination and lubrication, it should be
left on the microsaw during steam sterilization as well.
2. Sterilize using steam, following dynamic air removal cycle (ANSI/AAMI ST79, Sec-
tion 2.19), i.e. air removal via forced evacuation (ISO 17665-1, ISO/TS 17665-2)
at 135°C (275°F), for 3 minutes or at 132°C (269.6°F) for 4 minutes. In jur-
isdictions where sterilization for prions is required, sterilize at 135°C(275°F) for
18 minutes.
The recommended parameters for the sterilization cycle are:
l
The maximum temperature in the autoclave chamber does not exceed 137°C
(278.6°F), i.e. the nominal temperature of the autoclave is set at 134°C
(273.2°F), 135°C (275°F) or 135.5°C (275.9°F) taking into account the un-
certainty of the sterilizer with regard to temperature.
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The maximum duration of the interval at the maximum temperature of 137°C
(278.6°F) is in accordance with national requirements for moist heat ster-
ilization and does not exceed 30 minutes.
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The absolute pressure in the chamber of the sterilizer is comprised in the in-
terval 0.07 bar to 3.17 bar (1 psia to 46 psia).
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The rate of change of temperature does not exceed 15°C/min (59°F/min) for
increasing temperature and -35°C/min (-31°F/min) for decreasing tem-
perature.
l
The rate of change of pressure does not exceed 0.45 bar/min (6.6 psia/min)
for increasing pressure and -1.7 bar/min (-25 psia/min) for decreasing pres-
sure.
l
No chemical or physical reagents are added to the water steam.
CAUTION
Only use dynamic air removal cycles: pre-vacuum or steam flush pressure pulse
(SFPP) cycles.
