These definitions are obsolete. See our
NEW ISO 13485 2016 Definitions.
A manufactured product is defined
as a medical device if
it is used to:
Cope with human
- Prevent human disease.
- Diagnose human disease.
- Treat human disease.
- Alleviate human
- Monitor human disease.
Care for human
- Diagnose human injuries.
- Treat human injuries.
- Alleviate human injuries.
- Monitor human injuries.
- Compensate for human injuries.
- Investigate human anatomical issues.
- Replace human anatomical structures.
- Modify human anatomical structures.
- Support human anatomical structures.
- Investigate human physiological
- Replace human physiological functions.
- Modify human physiological functions.
- Support human physiological functions.
Support or sustain
taken from human bodies.
- In vitro reagents
- Related articles
Manufactured products that achieve
results by pharmacological,
immunological, or metabolic means are not
However, the results achieved by medical devices may be
assisted by these means.
medical device is a medical device that uses
electrical energy or
other source of power to make
it function. (Devices that are powered by the
or by gravity are not included in this
medical device is a medical device that:
is partly or totally inserted into the
body or a natural orifice and is
to stay there for 30 days
or more, or
• is used to
replace an epithelial surface
or the surface of the eye
and is expected
to stay in use for 30 days
medical procedures are used to insert
or apply implantable medical devices and
or medical procedures
must be used to remove them.
implantable medical device:
a medical device that uses
electricity or other energy, and
• is partly or
totally inserted into the human
body or a natural orifice by means of
surgical or medical procedures, and
is expected to stay there after
the procedure is completed.
medical device is a medical device that must
from live bacteria or other microorganisms and their spores.
National or regional standards and regulations often define
sterility requirements that sterile
medical devices must
Organizations often issue
advisory notices after their medical
devices have been delivered. These advisory
supplementary information about the device or specify
that should be taken. Advisory notices:
discuss the use of medical devices
discuss the modification of medical
discuss the destruction of medical
discuss the return of medical devices
National or regional regulations often
organizations to issue advisory notices.
see our ISO 9000
Quality Management Definitions,
our ISO 14971 Medical Device
Risk Management Definitions.
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Updated on May
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