KLS Martin group Angulus2 Instrucciones De Uso página 54

6.4 Packaging
Packaging has a significant impact on the result of the sterilization. Therefore the packaging
(sterile barrier system and where applicable protective wrapping) must be compatible to the
sterilization process.
The angled screwdriver and the accessories must be adequately packaged according
DIN EN 868-5, ISO 11607 or e.g. using containers according DIN EN 868-8. The packaging
method must allow the sterilization und guarantee the sterility until use.
For storage we recommend the wire basket (REF 50-990-40-04) and the small part storage
(REF 50-990-41-04).
6.5 Sterilization
• Clean, disinfect and lubricate prior to sterilization.
Recommended sterilization procedures
Fractionated pre-vacuum process (type B)
•
• Gravity displacement process (type N)
Sterilization time of 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 (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): temperature 121 °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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Instructions for Use
Angulus2 Angled Screwdriver
Revision 04