Pilot²
Doc. No 609 2210 v04
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Packaging
Pack the contra-angle in sterilization packages that meet the following
requirements:
•
The sterilization package must meet the applicable standards in respect of quality
and use and must be suitable for the sterilization method.
(For the US: The package must follow the FDA requirements)
•
The sterilization package must be large enough for the sterilization goods.
•
The filled sterilization package must not be under tension.
Sterilization
We recommend sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79.
Read the notes, follow the instructions and heed the warnings provided by the
manufacturers of steam sterilizers.
The program selected must be suitable for the medical device.
Recommended sterilization procedure:
•
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 13060:2014 A1:2018, EN 285:2015, ISO 17665:2017
** according to ANSI/AAMI ST55:2016, ANSI/AAMI ST79:2017
EN
