Biomedical Engineering Reference
In-Depth Information
Table 5.6: An Example of the Manufacturing Section in a PDS
Section 6: Manufacturing
Number
Comment
Source
6.1
Cleaning:
Device needs cleaning
post-manufacture.
6.2
Animal products:
Manufacturing to be free from
any animal by-products in the
manufacturing process.
6.3
ISO 9001:
Company rules
Company rules limit suppliers to
those who have ISO 9001 or ISO
13485 certification.
6.4
Stainless Steel - 316LVM:
Company rules
Company rules state that all SS
should be 316LVM.
Table 5.7: An Example of the Packaging and Transportation Section in a PDS
Section 7: Packaging and Transportation
Number
Comment
Source
7.1
Drop test:
Standards review
When packed the device should
withstand a drop from a height
of 1 m.
7.2
Instructions for use:
MDD - FDA
Each box to contain 1 IFU.
7.3
Shelf life:
Focus group report
The shelf life for the packaging is
to be 3 years.
7.4
Packaging dimensions:
Packaging office
To fit existing box, a footprint of
100 × 200 × 50 mm.
7.5
Labeling:
Packaging office
Keep package upright, label
required.
7.6
Assembly in situ:
Focus group
Assembly on delivery to be
minimized.
7.7
Vibration:
Standards review
Packaging to insulate device
from vibrations induced in road
transport.
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