Recommended sterilization procedures
> Fractionated pre-vacuum process (type B)
> Gravity displacement process (type N)
> Sterilization time at least 30 minutes at 121°C (250°F) or at least 3 minutes at 134°C (273°F)
> Maximum sterilization temperature 135°C (275°F)
Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent
test laboratory using the LISA 517 B17L steam sterilizer (Firma W&H Sterilization S.r.l., Brusaporto (BG)) and
the CertoClav MultiControl MC2-S09S273 gravitation sterilizer (CertoClav GmbH, Traun).
> Fractionated pre-vacuum process (type B): temperature 134°C (273°F) – 3 minutes*
> Gravity displacement process (type N): temperature121°C (250°F) – 30 minutes**
* according to EN 13060, EN 285, ISO 17665 / ** according to ANSI/AAMI ST55 , ANSI/AAMI ST79
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