MELAG MELAseal Pro, Руководство по эксплуатации

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DIN Specifications
23
Storage length for sterile medical products
Guidelines for the storage period of sterile medical products according to DIN 58953-8
from October 2010
This standard applies to the delivery, storage, commissioning, transport and provision (including the
packaging and marking necessary for these ends) of all sterile medical products to be used in healthcare
institutions such as hospitals, dental and medical practices.
This standard applies to all medical products delivered in a sterile state and which are to be handled in
such a manner so as that their quality is maintained until coming to aseptic application.
According to DIN 58953-8 section 7.1.1, responsibility for compliance with the specified storage
requirements and period is lies with the operator of the institution.
According to section 7.2, loss of sterility is dependent less on the length of the storage time as from
external influences during storage, as well as transport and handling. An ideal storage time can thus not
be generally specified. Table 2
only makes recommendations regarding the storage length of sterile
medical products.
The following requirements apply to the storage of sterile medical products:

The rooms must be dry, cool and easy to clean.

The rooms must not be accessible to everyday activity.

We recommend protected storage in cupboards or drawers.
Table 2: Storage length for sterile medical products
Packaging type Storage period
Sterile barrier system
Unprotected
storage
1)
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 provision for
immediate use
2)
Should be avoided as a
method of storage.
6 months,
not longer than the expiry date
Packaging system (a combination of a
sterile barrier system and sterile packaging) 5 years, as far as the manufacturer has not determined an
alternative expiry date.
1)
On shelves in rooms which do not correspond with room class 1 as defined by DIN 1946-4:2008-12
(Ventilation and air conditioning).
2)
Immediate use means application/use of the product within a maximum of 2 days/48 hours.