Biomedical Engineering Reference
In-Depth Information
Instructions for Use
Instructions for Use
Logos here
Symbols here
Logos here
Symbols here
Product name
here
Product name
here
2
2
Non
sterile
Sterile
R
Indications for use:
Indications for use:
Insert a single statement describing what your device is
to be used for
Insert a single statement describing what your device is
to be used for
Insert a statement of the hazards of reuse
Insert a statement of the hazards of reuse
Cleaning and sterilization instructions
Insert simple to understand cleaning and sterilizing
instructions here
Insert statement about checking packaging for damage
Insert sterilization protocol:
If steam sterilized insert equivalence table here too
Manufacturer's
details
Contact
details
Manufacturer's
details
Contact
details
IFU document No
Version
Approval
Date
IFU document No
Version
Approval
Date
Figure 11.18
Example IFU pro forma: (a) nonsterile single use item; (b) sterile single use item.
Table 11.3: Standard Steam Sterilization Cycles (ISO, 2009)
Temp (°C)
Duration (Minutes)
121
15
126
10
134
3
you may need to supply one per device. There is no rough and ready rule to follow; the
choice is yours. However, if in doubt supply one copy per device. Do not forget you must
still include the contents of the IFU described in the previous section.
Nowadays, it is commonplace for these documents to be in a PDF format that can be
downloaded from your website.
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