Biomedical Engineering Reference
In-Depth Information
1. Customer:
1.1
Hole diameter 4.8 mm
Initial focus group
1.2
Overall length 200 mm (nominal)
Initial focus group
1.3
Device to be reusable
Initial focus group
2 Regulatory and Statutory:
2.0
Device to meet essential and
general requirements of a
medical device
2.1
Initial estimate is that this is a
reusable surgical instrument and
hence CE/FDA Class I (510(k)
exempt)
93/42/EC Annex IX rule 6
CFR 21 Reg. No 888.4540
2.2
Material to be selected from those
approved in standards
ISO 7153
ASTM F899-09
2.3
Labeling to show it is supplied
nonsterile
93/42/EC
2.4
In EU labeling to comply with
standard
93/42/EC
BS ISO 15223-2:2010
2.5
In U.S. labeling to comply with
regulations
CFR 21
2.6
IFU to be supplied with each
item and to include cleaning and
sterilization instructions
93/42/EC
CFR 21
2.7
Declaration of conformity required
93/42/EC
3 Technical:
3.1
Material to withstand high
alkalinity (pH 13-14) in washers
Cleaning and sterilization review
3.2
Material to withstand + 130°C in
steam sterilizers
Cleaning and sterilization review
4 Performance:
4.1
Hole production time in bone to
be no worse than existing 4.8 mm
drills
4.2
Hole production to perform
consistently for 25 individual uses
4.3
Breaking torque to be no worse
than existing 4.8 drills
4.4
Bending strength to be no worse
than existing 4.8 drills
4.5
“Point” to locate hole securely to
within ± 1 mm
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