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New Approaches to Assessing Biocompatibility for Medical Devices

The regulatory environment for biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have typically been addressed with biocompatibility testing on animals; however, alternate options are now available using literature research and chemical characterization tests when appropriate to reduce animal testing. Considerable progress is being made in the development and standardization of new in vitro test methods; particularly for cytotoxicity, sensitization and irritation, the basic tests performed for any medical device regardless of the device’s application. These alternative in vitro methods provide multiple benefits, including: less sample amount, less time required to perform the test, and reduced animal use.

What will be learned:

  • Learn how to use a risk assessment approach for process and material changes
  • Understand how to use material and chemical characterization to reduce animal testing
  • Update on development of alternative in vitro testing methods for irritation and sensitization

Duration: 29:40

 
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Nelson Laboratories, LLC

http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

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Espergaerde, Denmark
Aa. Louis-Hansens Alle 11
Espergaerde
3060
Denmark
T +45 (0) 49 12 79 72

Gibraltar Laboratories, Fairfield, New Jersey, USA
122 Fairfield Road
Fairfield, NJ
07004-2405
United States
T (973) 227-6882

Itasca, Illinois, USA
1500 W. Thorndale Ave
Itasca, IL
60143
United States
T (630) 285-9121

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Cuautitlan Izacalli
Mexico
CP 54730
Mexico
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Leuven
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T +32 (0) 16 40 04 84

Ontario, California, USA
687 S. Wanamaker Avenue
Ontario, CA
91761
United States
T (909) 969-2302

 
 
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