Use of Chemical Characterization to Assess the Equivalency of Medical Devices and Materials describes chemical characterization techniques and why they are important.

1. Use of Chemical Characterization to Assess the
Equivalency of Medical Devices and Materials
Darin R. Kent, Ph.D., DABT
Medical Research Toxicologist
NAMSA

2. 2
Overview
 What is chemical characterization?
 Why is it important to characterize materials and
medical devices?
 Change control and material equivalency

3. What is Characterization?
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4. What is Characterization?
A process that describes the nature of materials
used in medical devices
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5. What is Characterization?
The process is a series of tests that delineates the
properties of the material
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 Chemical
 Toxicological
 Physical
 Mechanical
 Morphological
 Electrical

6. Why Characterize Materials and
Medical Devices?
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7. Why Characterize Materials and
Medical Devices?
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 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)

8. Why Characterize Materials and
Medical Devices?
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 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)
 Performance

9. Why Characterize Materials and
Medical Devices?
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 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)
 Performance
 Problem Solving (change control and material equivalency)

10. Why Characterize Materials and
Medical Devices?
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 Safety
 As part of an assessment of the overall biological safety
of a medical device (EN ISO 10993-1 and 14971)
 Performance
 Problem Solving (change control and material equivalency)
 Regulatory (Compliance with FDA, Notified Bodies and ISO
Standards)

11. Why Characterize Materials and
Medical Devices?
 Establishes baseline testing that will serve as a benchmark
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12. Why Characterize Materials and
Medical Devices?
 Establishes baseline testing that will serve as a benchmark
 Baseline testing serves as a standard by which other
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materials may be measure or judged

13. Why Characterize Materials and
Medical Devices?
 Establishes baseline testing that will serve as a benchmark
 Baseline testing serves as a standard by which other
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materials may be measure or judged
 Standard tests used to compare the quality and
performance of future materials or processes

14. Why Characterize Materials and
Medical Devices?
 Materials characterization is a dynamic ongoing process to
be used throughout the lifetime of a medical device
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15. Why Characterize Materials and
Medical Devices?
 Materials characterization is a dynamic ongoing process to
be used throughout the lifetime of a medical device
 Materials characterization helps monitor material quality,
manufacturing processes and sterilization procedures
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16. Why Characterize Materials and
Medical Devices?
 Materials characterization is a dynamic ongoing process to
be used throughout the lifetime of a medical device
 Materials characterization helps monitor material quality,
manufacturing processes and sterilization procedures
 When used properly, will eliminate the need to repeat
expensive and time consuming biological testing to qualify
new lots or vendors
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17. Change Control and Material
17
Equivalency
What is Change Control?

18. Change Control and Material
18
Equivalency
What is Change Control?
 The processes and procedures to manage changes being
made to a product

19. Change Control and Material
19
Equivalency
What is Change Control?
 The processes and procedures to manage changes being
made to a product
 The review, approval/disapproval, implementation, tracking,
closure and status reporting of proposed changes to an item

20. Change Control and Material
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Equivalency
ISO 10993-18
Biological Evaluation of Medical Devices, Part 18:
Chemical Characterization of Materials

21. Change Control and Material
21
Equivalency
ISO 10993-18
Biological Evaluation of Medical Devices, Part 18:
Chemical Characterization of Materials
 Used to judge equivalency of proposed material to a
clinically established material

22. Change Control and Material
22
Equivalency
ISO 10993-18
Biological Evaluation of Medical Devices, Part 18:
Chemical Characterization of Materials
 Used to judge equivalency of proposed material to a
clinically established material
 Also used to judge equivalency of a prototype device to a
final device

23.  To view the complete series about the Use of Chemical
Characterization to Assess the Equivalency of Medical
Devices and Materials
 Visit NAMSA Seminars
 For information about the services NAMSA can offer you
regarding chemical characterization
 Check out our Materials Characterization and Analytical
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Chemistry page
 For additional information
 Download our brochure on Material Characterization
and Analytical Chemistry
 Read Using Chemical Characterization to Show
Equivalency written by David Albert & Amy Hoffmann
published in MD&DI
 If you have any questions or would like to request a quote
 Contact us at clientcare@namsa.com.