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Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions.

ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016 sixteen new terms are added with longer definitions. Let's see what are the differences and similarities between the editions.

Terms that remained the same

  • Advisory notice - giving advice about the delivery, use and modification of the medical device
  • Implantable medical device - a medical device implanted in or on the surface of the human body, that can be removed by medical or surgical way and remain in or on the surface of the human body at least 30 days
  • Medical device - (instruments, software, machines, materials…) used alone or in combination for one or more medical purposes.

The following Term has been expanded to make it more understandable in ISO 13485:2016

  • Labeling - documentation of use and any other information (technical description, purpose, and proper use), except shipping documentation

Terms that NO LONGER EXIST in the new ISO 13485:2016

  • Active medical device
  • Active implanted medical device

The only difference between the medical device and active medical device was that the active device needs the external power source, so the Active Medical Device terms have been removed from the new ISO 13485:2016.

NEW TERMS used in ISO 13485:2016

  • Authorized representative - Representative is a legal person authorized by manufacturer to represent or act on its behalf regarding legal matters.
  • Clinical evaluation - documentation which verifies the clinical safety and performance of a medical device
  • Complaint - document or negative communication that defines problems about a medical device that has been placed on the market. Complaint means general problems that can be found in the medical device which includes safety, quality, identity, usability, etc.
  • Distributor - a person who furthers the availability of a medical device to the end user
  • Importer - a person who makes a medical device available in other country or jurisdiction
  • Life-cycle - includes all phases in the life of a medical device, from the initial idea across design, development, production, control… until the use, final decommission and disposal
  • Manufacturer - person(s) who design and/or manufactures a medical device
  • Medical device family - group of medical devices with the same design, safety characteristics, intended use and function
  • Performance evaluation – a document that verifies the ability of an in vitro medical device to access its intended use
  • Post-market surveillance – Collecting feedback information from the released medical device product. Example: a manufacturer releases a new heart rate monitor on the market, later he would ask for feedback from hospitals, where the monitor is used. The new information can be used for further development, different analytics and could point out unseen difficulties or problems in usage.
  • Product - ISO 13485:2016 defines a “product” as a result of one of the following 4 process categories:
    1. Services
    2. Software
    3. Hardware
    4. Processed materials

If a product belongs to more than one category, it will be categorized by the dominant element.  For example, a simple car as a product includes all 4 categories: a hardware (steering wheel), processed materials (cooling fluid), software (driver’s manual), and service (operating explanations given by the salesman)

  • Purchased product – product reached outside the organization’s quality management system
  • Risk - a probability of harm and the severity of that harm
  • Risk management - using management policies, procedures, and practices for risk analyzing, evaluating and monitoring
  • Sterile barrier system - presents the wrapping, that keeps the product aseptic
  • Sterile medical device - up to the standard the requirements of sterility

The ISO 13485:2003 defined fewer terms to focus on, but the new addition is spreading its standards wider, that makes this edition of ISO much stricter.
 


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