Page 53 - Kit LUMIS CHU de RENNES Intervention le 16-03-2017

Instructions for Cleaning, Sterilization, Inspection and
®
Maintenance of SpineVision medical devices
English version

Application date : 2015-12-09 Reference document: CI_01EN

Additional information about sterilization validation:

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Studies demonstrated that steam-sterilization provide a Sterility Assurance Level (SAL) of at least 10 with the
following configuration:
 For the parameters 132°C, 4 minutes:
 Trays without handles packaged in double wrap
 Handles packaged singly in double wrap
 Additional instruments, that are not intended to be contained in kits (according to the standard set
composition detailed below), packaged singly in double wrap
 For the parameters 134°C, 18 minutes:
 Trays with handles packaged in double wrap
 Additional instruments, that are not intended to be contained in kits (according to the standard
composition detailed below), packaged singly in double wrap

When several instruments are sterilized during the same sterilization operation, it is necessary to check that the
permissible maximum load of equipment is not exceeded.

Please note that according EN ISO 17665 the final responsibility for validation of sterilization techniques and
equipment lies directly with the hospital.

b. Storage recommendations

SpineVision® Systems do not require specific storage. After sterilization, please store the medical devices in the
sterilization packaging in a dry and dust-free place. Storage conditions must be in compliance with good practices in
health care facilities, with a controlled environment free of dust, insects, moisture and vermin and protected from
humidity and temperature extremes.

The shelf life is depending on the sterile barrier employed, storage manner, environmental and handling conditions.
A maximum shelf life for sterilized medical devices before use should be defined by each health care facility.

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Computer filename: CI_01EN.docx