ISO 13485 2003
PLAIN ENGLISH DEFINITIONS
ISO 13485 is a Quality
Management Standard for Medical Devices.
A manufactured product is defined
as a medical device if it is used
Cope with human
- Prevent human disease.
- Diagnose human disease.
- Treat human disease.
- Alleviate human disease.
- 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.
Medical devices can include:
- In vitro reagents
- Related articles
Manufactured products that achieve results by
immunological, or metabolic means are not medical devices.
However, the results achieved by medical devices may be
An active 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 definition.)
An implantable medical device
is a medical device that:
is partly or totally inserted into the human
body or a natural orifice and is expected
to stay there for 30 days or more,
• is used to replace an
or the surface of the eye and is expected
to stay in use for 30 days or more.
Surgical or medical
procedures are used to insert
or apply implantable medical devices and surgical
or medical procedures must be used to remove them.
An active implantable medical
• is a medical device
electricity or other energy, and
• is partly or totally inserted
into the human
body or a natural orifice by
surgical or medical procedures, and
is expected to stay there after
the procedure is completed.
A sterile medical device
is a medical device that must be free
from live bacteria or other microorganisms
and their spores.
National or regional standards and regulations often define
sterility requirements that sterile
medical devices must meet.
Organizations often issue
advisory notices after their medical
devices have been delivered.
These advisory notices provide
supplementary information about the device or specify actions
that should be
taken. Advisory notices:
discuss the use of medical devices
discuss the modification of
discuss the destruction of
discuss the return of medical
National or regional regulations often require
organizations to issue advisory notices.
Also see our
ISO 9001 Quality Management Definitions,
our ISO 14971
Medical Device Risk Management Definitions.
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Praxiom Research Group Limited
Updated on July 17, 2012.
First published on December 20, 2004.
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