Jove
Visualize
Contact Us

Related Experiment Videos

ISO 10993, Part 18: A structured approach to material characterisation.

D Ingles1

  • 1Rapra Technology Ltd, Shawbury, Shrewsbury SY4 4NR, UK. dingles@rapra.net

Medical Device Technology
|July 11, 2003
PubMed
Summary

A biological risk analysis ensures medical device material safety. ISO 10993 Part 18 provides a framework for chemical characterization when data is unavailable, guiding companies on necessary testing and supplier information.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Thermal degradation of driftwood: Determination of the concentration of sodium, calcium, magnesium, chlorine and sulfur containing compounds.

Waste management (New York, N.Y.)ยท2016
See all related articles
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Area of Science:

  • Biomaterials science
  • Medical device safety
  • Chemical characterization

Background:

  • Biological risk analysis is crucial for medical device material safety.
  • Chemical characterization data is often essential but may be unavailable.
  • ISO 10993 Part 18 addresses this gap by outlining testing frameworks.

Purpose of the Study:

  • To highlight the importance of ISO 10993 Part 18 for medical device material safety.
  • To guide companies in preparing for the implementation of Part 18.
  • To emphasize the need for robust chemical characterization of medical device materials.

Main Methods:

  • The abstract references the framework provided by ISO 10993 Part 18.
  • It implies a review of existing data and potential testing requirements.
  • Focuses on the process of chemical characterization for risk assessment.

Main Results:

  • A well-executed biological risk analysis provides assurance of material safety.
  • ISO 10993 Part 18 offers a structured approach to chemical characterization.
  • Companies need to proactively assess data availability and testing needs.

Conclusions:

  • Adherence to ISO 10993 Part 18 is vital for medical device material safety.
  • Proactive engagement with suppliers and data assessment is necessary.
  • Anticipating and planning for additional testing ensures compliance and safety.

Related Experiment Videos