The terms and definitions appeared in the Standard (the ISO 13485 as well as the ISO 9001) are inseparable and integral part of the Standard. In order to clear matters, the Standard  present his interpretations and explanations to the terns and definition presented. You may regard this chapter as a comparison chart between you and the ISO organization concerning terms and definitions. In this article we would review the ISO 13485 Standard requirements for terms and definitions and as always we would refer to the ISO 9001 Standard.

The purpose of this chapter is to determine that where there are any open arguments regarding terms and definitions, the ones mentioned throughout this standard are valid.
The chapter determines that anywhere throughout the Standard, (the IS0 9001 Standard or the IS0 13485 Standard), where the term "product" appears, it may be considered as service as well. The standard regards services as products and any requirement of the standard applies the services as well.
The IS0 13485 Standard determines that anywhere throughout the standard, where the term "medical devices" appears, it may be considered as a related service provided by the organization as well.  The standard regards related for medical devices as well as the medical devices and any requirement of the standard applies the services as well.
The IS0 13485 Standard presents a list of terms:

Active implantable medical device –

Active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
Active medical device  - Medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.

Advisory notice -

Notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action should be taken in:

• The use of a medical device
• The modification of a medical device
• The return of the medical device to the organization that supplied it, or 
• The destruction of a medical device 

The advisory notice shall cover actions taken by the representative from the organization: manufacture, importer, and distributor – the responsible party that is required to maintain the notice. Notifications may recall or correct the device or may notify users and/or owners, of defectiveness and/or any potential defectiveness in the device, once revealed by the any of the parties mentioned. According to the IS0 13485 Standard, notification shall be advised when:

• The use of the medical device is hazardous
• Any parameter of the medical devices fails to meet the intended requirement such as: effectiveness, performance, safety – which was claimed by the repetitive prior to distribution.
• The medical device does not meet with any regulatory requirements relevant to where the product was supplied. 

• How to use the medical device.
• What is wrong with the medical device.
• What is the process of communication with manufacture (address, service line, web address, etc).
• The destruction of the medical device.

Customer complaint –

Customer complaint written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

Implantable medical device -

The medical device is intended to:

• To be totally or partially introduced into the human body or a natural orifice, or
• To replace an epithelial surface or the surface of the eye

by surgical intervention, and which is intended to remain after the procedure for at least 30 days, and which can only be removed by medical or surgical intervention
NOTE - This definition applies to implantable medical devices other than active implantable medical devices.

Labeling -

Written, printed or graphic matter affixed to a medical device or any of its containers or wrappers, or accompanying a medical device, related to identification, technical description, and use of the medical device, but excluding shipping documents
NOTE - Some regional and national regulations refer to “labeling” as “information supplied by the manufacturer.”

Medical device  -

Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination,  for human beings for one or more of the specific purpose(s) of :

• Diagnosis, prevention, monitoring, treatment or alleviation of disease, 
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury, 
• Investigation, replacement, modification, or support of the anatomy or of a physiological process, 
• Supporting or sustaining life, 
• Control of conception, 
• Disinfection of medical devices,  providing information for medical purposes by means of in vitro examination of specimens derived from the human body,
• And which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

NOTE - This definition has been developed by the Global Harmonization Task Force (GHTF). See bibliographic reference [15].
 

Sterile medical device -

Category of medical device intended to meet the requirements for sterility.
NOTE - The requirements for sterility of a medical device might be subject to national or regional regulations or standards.
 

View our article about the ISO 13485 Standard Normative references requirements