Operating manual MELAseal
®
100
Page 7
Rev.: 0 – 99/0211
BA_1_GB_seal100eco.doc
5. German
DIN
regulations
5.1. Width of sealed seams and clear space ________________________________________
German Standard DIN 58953 Part 7 requires that
sealed seams in transparent packaging material
should have a width of at least 8 mm. With a width of
10 mm for its sealed seams, the MELAseal
®
100 is
considerably better than this minimum requirement.
DIN 58953 Part 7 specifies that a clear space of at
least 30 mm be left below the sealing border
between the sterilisation goods and the seam in
order to ensure a perfect seal without wrinkles. This
applies both for bags and transparent material from
the roll.
5.2. Storage life ________________________________________________________________
Sterile goods packaging
Type of packaging
Length of storage
unprotected
1
Length of storage
protected
2
Paper bags in accordance
with DIN 58 953 Part 3
Sterile goods single
packaging
24 hours
6 weeks
Transparent sterilization packaging
in accordance with
DIN 58953 Part 4
Two-stage sterile
goods packaging
6 weeks
6 months
Sterile-goods
store
packaging
3 years
3,4
1)
E.g. on shelves
2)
E.g. in cupboards or drawers
3)
Before opening sterile-goods store packaging, dust shall be removed from it in accordance with
regulations.
4)
The storage life of sterile-goods store packaging which has been opened is not altered if it has been
closed again in accordance with regulations.
A comment on the table in Section 8.2 of the DIN
standard says:
"The information in the table only represents
standard values. These do not mean that longer
storage periods are not possible under particularly
favourable storage conditions, or that a longer
duration of storage necessarily leads to the pack
contents being recontaminated during storage, but
signify that if these periods are observed,
recontamination of the contents when they are
opened and correctly removed is extremely
unlikely."
An additional explanatory note goes into further
detail:
"The risk in storing sterile goods is not that micro-
organisms may penetrate the sterile goods
packaging, provided that dry storage conditions
are ensured and the packaging material has the
required germ-proof qualities, but that when the
sterile goods packaging is opened after storage,
micro-organisms contained in dust particles may
be stirred up and could recontaminate the sterile
objects when these are removed.
"The extent of dust loading depends upon the
dust content of the air and on the duration of
storage. For these reasons the storage period
should be kept as short as possible."
5.3. VDE regulations ____________________________________________________________
In accordance with current VDE regulations, this appliance is not suitable for use in areas at risk of
explosion.
It should only be serviced by the manufacturer or a specially authorised agent (dealer or customer service).