ISO 13485 2003

PLAIN ENGLISH DEFINITIONS

ISO 13485 is a Quality Management Standard for Medical Devices

Medical Device

A manufactured product is defined
as a medical device if it is used to:

• Cope with human disease.

  • Prevent human disease.
  • Diagnose human disease.
  • Treat human disease.
  • Alleviate human disease.
  • Monitor human disease.

• Care for human injuries.

  • Diagnose human injuries.
  • Treat human injuries.
  • Alleviate human injuries.
  • Monitor human injuries.
  • Compensate for human injuries.

• Meet human anatomical needs.

  • Investigate human anatomical issues.
  • Replace human anatomical structures.
  • Modify human anatomical structures.
  • Support human anatomical structures.

• Maintain human physiological functions.

  • Investigate human physiological functions.
  • Replace human physiological functions.
  • Modify human physiological functions.
  • Support human physiological functions.

• Support or sustain human life.

• Control human conception.

• Disinfect human medical devices.

• Examine specimens taken from human bodies.

Medical devices can include:

• Instruments
• Appliances
• Implants
• Machines
• Software
• Materials
• Calibrators
• Apparatuses
• In vitro reagents
• Related articles

Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not medical devices. However, the results achieved by medical devices may be assisted by these means.

Active Medical Device

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 human body or by gravity are not included in this definition.)

Implantable Medical Device

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, or

• is used to replace an epithelial surface 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.

Active Implantable Medical Device

An active implantable medical device:

• is 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.

Sterile Medical Device

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 the sterility requirements that sterile medical devices must meet.

Advisory Notice

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 medical devices

• discuss the destruction of medical devices

• discuss the return of medical devices

National or regional regulations often require organizations to issue advisory notices.

Home Page

Introduction to ISO 13485 Quality System Standard for Medical Devices

ISO 13485 2003 Gap Analysis Tool