Sterilization; Storage And Transport; Environmental Information/Disposal; Disposal - KLS Martin group Kit de préparation des fibres stérilisable Mode D'emploi

5.7

Sterilization

Tools
Fiber stripper, 400 µm
Fiber stripper, 600 µm
Fiber stripper, 800 µm
Ceramic knife
Silicone support
Carrying case
Tab. 5-3 Sterilization options for accessories
The steam sterilization procedure set out below is validated for sterilization.
Steam sterilization with fractionated pre-vacuum
Medium
Sterilization time
Sterilization temperature
Tab. 5-4 Steam sterilization of the accessories
The process parameters described also cover the standard sterilization process at 134°C, 5 minutes
sterilization duration, pre-vacuum, according to DIN EN 285.
Evidence of the suitability of steam sterilization for sterilization of the products (stripping tools: 79-116-40-
04, 79-116-60-04, 79-116-80-04) was provided by an independent, officially accredited and recognized (§
15 (5) German Medical Devices Act) test laboratory using the steam sterilizer Euro-Selectomat (Münchener
Medizin Mechanik GmbH, Planegg) and using the fractionated vacuum process.
5.8

Storage and transport

Keep products clean and secure during storage and transport. The carrying case is not suitable for sterile
storage. When returning products, send only cleaned and disinfected products in sterile packaging.

6 Environmental information/disposal

6.1

Disposal

The ceramic knife must be disposed of in the sharps disposal as infectious. The rest of the fiber preparation
set should be disposed of as infectious.
6.2

National regulations

Follow national waste management regulations and guidelines for all disposal activities.
36
REF
79-116-40-04
79-116-60-04
79-116-80-04
79-110-01-04
79-220-00-04
–
saturated water vapor
3 min
132°C, plus tolerance
Sterilizable Fiber Preparation Set
Instructions for Use
Sterilization method
Steam sterilization
yes
yes
yes
yes
yes
no
Revision 03