ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process discusses what ISO 10993-1 addresses, as well as the general principles governing the biological evaluation of medical devices within a risk management process.

1. Use of ISO 10993 Part 1 in the Evaluation of
Medical Devices
Don Pohl
Manager, Safety & Validation
NAMSA

2. ISO 10993-1 was first published in 1992
2

3. It was revised in 1997, 2003 and 2009
3

4. This standard is recognized globally, but
the overall acceptance and use can vary
4

5. This is especially true for FDA
5

6. ISO 10993-1 provides information on
6
required tests

7. ISO 10993-1 provides information on
7
required tests
Evaluation of medical devices

8. ISO 10993-1 provides information on
8
required tests
Evaluation of medical devices
Categorization of devices based on nature
and duration of patient contact

9. ISO 10993-1 provides information on
9
required tests
Evaluation of medical devices
Categorization of devices based on nature
and duration of patient contact
Evaluation of data from all sources:
Materials
Prior use
Clinical data
Testing performed

10. ISO 10993-1 provides information on
10
required tests
Address gaps in data available versus risks

11. ISO 10993-1 provides information on
11
required tests
Address gaps in data available versus risks
Testing needed for the device to address
gaps in available data

12. ISO 10993-1 provides information on
12
required tests
Address gaps in data available versus risks
Testing needed for the device to address
gaps in available data
Overall assessment of the device

13. 13
ISO 10993-1
Covers devices that have direct or indirect patient
contact

14. 14
ISO 10993-1
Covers devices that have direct or indirect patient
contact
Does not cover risks associated with mechanical
failure

15. 15
ISO 10993-1
Covers devices that have direct or indirect patient
contact
Does not cover risks associated with mechanical
failure
Final evaluation is of the final, finished medical
device

16. General
Principles 8
16

17. Selection and evaluation of
materials/device requires a structured
plan of assessment – detailed plan
17
1

18. Selection and evaluation of
materials/device requires a structured
plan of assessment – detailed plan
18
1
Evaluation program based on ISO 14971

19. Selection and evaluation of
materials/device requires a structured
plan of assessment – detailed plan
19
1
Evaluation program based on ISO 14971
Decisions by qualified individuals

20. Selection and evaluation of
materials/device requires a structured
plan of assessment – detailed plan
20
1
Evaluation program based on ISO 14971
Decisions by qualified individuals
Weigh advantages/disadvantages of:
Physical/chemical characteristics of materials
Historical data –clinical use or human exposure
Existing toxicological data or biological safety data on
materials
Test procedures considered

21. Selection and evaluation of
materials/device requires a structured
plan of assessment – detailed plan
21
1
Conclusion may indicate that additional testing is
not required if the material has a safe history of
use in a specified role and physical form that is
equivalent to that of the device under review

22. 22
2 Selection of materials

23. 23
2 Selection of materials
Fitness for purpose

24. 24
2 Selection of materials
Fitness for purpose
Chemical, toxicological, physical, mechanical
properties

25. 25
2 Selection of materials
Fitness for purpose
Chemical, toxicological, physical, mechanical
properties
Key principle for materials as it is directed towards
the material itself
Applicable Material Standards: Example - ASTM F136-08e
Wrought Titanium-6 Aluminum-4 Vandadium ELI Alloy for
Surgical Implant Applications

26. Consider relevance of all potential
factors in the biological evaluation
26
3

27. Consider relevance of all potential
factors in the biological evaluation
27
3
Materials of manufacture

28. Consider relevance of all potential
factors in the biological evaluation
28
3
Materials of manufacture
Additives, contaminants and residues

29. Consider relevance of all potential
factors in the biological evaluation
29
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes

30. Consider relevance of all potential
factors in the biological evaluation
30
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes
Leachable substances

31. Consider relevance of all potential
factors in the biological evaluation
31
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes
Leachable substances
Degradation products

32. Consider relevance of all potential
factors in the biological evaluation
32
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes
Leachable substances
Degradation products
Material characterization shall precede biological
testing

33. Consider chemical composition and
exposure of device to the patient in
the assessment
33
4

34. Consider chemical composition and
exposure of device to the patient in
the assessment
34
4
Degree of evaluation determined by the nature,
degree, duration and frequency of the exposure

35. Consider chemical composition and
exposure of device to the patient in
the assessment
35
4
Degree of evaluation determined by the nature,
degree, duration and frequency of the exposure
Hazards may also vary depending on the
composition

36. All potential biological hazards
identified should be evaluated
36
5

37. All potential biological hazards
identified should be evaluated
37
5
“…this does not imply that testing for all potential
hazards will be necessary or practical”

38. All potential biological hazards
identified should be evaluated
38
5
“…this does not imply that testing for all potential
hazards will be necessary or practical”
Both short term effects and long term effects to
be evaluated as appropriate

39. All potential biological hazards
identified should be evaluated
39
5
“…this does not imply that testing for all potential
hazards will be necessary or practical”
Both short term effects and long term effects to
be evaluated as appropriate
Various biological effects should be considered as
appropriate for the device in question

40. Tests deemed necessary to be based
on end use of device
40
6

41. Tests deemed necessary to be based
on end use of device
41
6
GLP Guidance

42. Tests deemed necessary to be based
on end use of device
42
6
GLP Guidance
Include in vitro studies where possible

43. 7 Re-evaluate as necessary
43

44. 7 Re-evaluate as necessary
44
Examples
Change in source of material
Change in processing
Change in sterilization

45. 7 Re-evaluate as necessary
45
Examples
Change in source of material
Change in processing
Change in sterilization
Follow-up testing may be necessary and amount
can vary

46. Consider all information for thorough
overall assessment
46
8

47. Consider all information for thorough
overall assessment
47
8
Vendor information on materials

48. Consider all information for thorough
overall assessment
48
8
Vendor information on materials
Non-clinical tests

49. Consider all information for thorough
overall assessment
49
8
Vendor information on materials
Non-clinical tests
Post market experience

50.  To view the complete presentation on ISO
10993 Part 1
 Check out NAMSA’s Seminars
 You can view the entire ISO 10993
50
Series here
 For information about the services NAMSA
can offer you regarding risk management
 Visit our Product and Process Risk
Assessment page
 For additional information
 Contact us at clientcare@namsa.com.