10 Standard specifications
22
Guidelines for the storage duration of sterile medical devices in accordance with DIN 58953-8
This standard applies to the delivery, storage, commissioning, transport and provision (including the pack-
aging and labelling of sterile medical devices to be used in healthcare institutions such as hospitals and
dental and medical practices). This standard applies to all medical devices delivered in a sterile state and
which are to be handled in such a manner so as to maintain their quality until coming to aseptic applica-
tion. According to DIN 58953-8 section 7.1.1, responsibility for compliance with the specified storage re-
quirements and period lies with the operator of the institution. According to section 7.2, loss of sterility is
dependent less on the length of the storage duration as from external influences during storage, as well as
transport and handling. An defensible storage time can thus not be generally specified. The following table
only makes recommendations regarding the storage duration of sterile medical devices.
Storage duration for sterile medical devices
Packaging type
Storage duration
Sterile barrier system
Unprotected storage
*
)
Protected storage
Paper bag in accordance with
DIN EN 868-4 and heatable, self-
sealing transparent bag and
tubing of paper and plastic
composite film in accordance with
DIN EN 868-5, or other equivalent
packaging.
Serves supply for immediate
use**
)
. Should be avoided as a
method of storage.
6 months, although no longer than
expiry date
Packaging system (a combination
of a sterile barrier system and
protective packaging)
5 years, as far as the manufacturer has not determined an alternative
expiry date.
*
)
On shelves in rooms which do not correspond with room class II as defined by DIN 1946-4.
**
)
Immediate use means application or use of the product within a maximum of two days or 48 hours.
