Packaging; Sterilization; Storage And Transport - KLS Martin group Reconstruction de l'avant-bras IPS Implants Mode D'emploi

Instructions for Use
IPS® Implants Forearm Reconstruction
5.6

Packaging

Approved sterilization packaging (e.g. conforming to EN 868, ISO 11607) must be used for sterilization,
subsequent transportation and storage.
5.7

Sterilization

Risk of infection from non-sterile handling!
Improper sterilization and non-sterile handling of the products can pose serious health hazards to
patients.
The operator/user is responsible for cleaning, disinfecting and sterilizing these products. It is essential that
national regulations, including restrictions, be observed.
Sterilization can be carried out in a sterilizer according to EN 285 and can be validated according to
ISO 17665. Based on the results of our validation, the following sterilization procedures can be applied:
Steam sterilization with fractionated pre-vacuum
Pre-vacuum cycles
Medium
Holding time
Sterilization temperature
Drying time
5.8

Storage and Transport

Products
• must be stored in a clean, cool and dry location,
• must be protected against mechanical damage,
• must be handled with great care. Do not drop or throw.
For sterilization, subsequent transport and storage,
use approved sterilization packaging (e.g. acc. to EN 868, ISO 11607).
In case of return shipments, send only clean and disinfected products in sterile packaging.
Revision 1
Procedure 1
3 ×
Saturated water vapor
5 min
134 °C, temperature band up to 137 °C
10 min
Procedure 2
3 ×
Saturated water vapor
3 min
132 °C, temperature band up to 135 °C
10 min
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