Use of ISO 10993 Part 1 in the Evaluation of Medical Devices Don Pohl Manager, Safety & Validation NAMSA
ISO 10993 Series Part 1: Evaluation and Testing In The Risk Management Process
Jul 07, 2015
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.
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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
3
It was revised in 1997, 2003 and 2009
4
This standard is recognized globally, but
the overall acceptance and use can vary
5
This is especially true for FDA
6
ISO 10993-1 provides information on
required tests
7
ISO 10993-1 provides information on
required tests
Evaluation of medical devices
8
ISO 10993-1 provides information on
required tests
Evaluation of medical devices
Categorization of devices based on nature
and duration of patient contact
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ISO 10993-1 provides information on
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
required tests
Address gaps in data available versus risks
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ISO 10993-1 provides information on
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
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
ISO 10993-1
Covers devices that have direct or indirect patient
contact
14
ISO 10993-1
Covers devices that have direct or indirect patient
contact
Does not cover risks associated with mechanical
failure
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
Principles8
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Selection and evaluation of materials/device requires a structured plan of assessment – detailed plan
1
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Selection and evaluation of materials/device requires a structured plan of assessment – detailed plan
1
Evaluation program based on ISO 14971
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Selection and evaluation of materials/device requires a structured plan of assessment – detailed plan
1
Evaluation program based on ISO 14971
Decisions by qualified individuals
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Selection and evaluation of materials/device requires a structured plan of assessment – detailed plan
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 exposureExisting toxicological data or biological safety data on
materialsTest procedures considered
21
Selection and evaluation of materials/device requires a structured plan of assessment – detailed plan
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
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Selection of materials2
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Selection of materials2
Fitness for purpose
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Selection of materials2
Fitness for purpose
Chemical, toxicological, physical, mechanical properties
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Selection of materials2
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
3
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Consider relevance of all potential factors in the biological evaluation
3
Materials of manufacture
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Consider relevance of all potential factors in the biological evaluation
3
Materials of manufacture
Additives, contaminants and residues
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Consider relevance of all potential factors in the biological evaluation
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes
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Consider relevance of all potential factors in the biological evaluation
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes
Leachable substances
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Consider relevance of all potential factors in the biological evaluation
3
Materials of manufacture
Additives, contaminants and residues
Manufacturing processes
Leachable substances
Degradation products
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Consider relevance of all potential factors in the biological evaluation
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
4
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Consider chemical composition and exposure of device to the patient in the assessment
4
Degree of evaluation determined by the nature, degree, duration and frequency of the exposure
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Consider chemical composition and exposure of device to the patient in the assessment
4
Degree of evaluation determined by the nature, degree, duration and frequency of the exposure
Hazards may also vary depending on the composition
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All potential biological hazards identified should be evaluated
5
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All potential biological hazards identified should be evaluated
5
“…this does not imply that testing for all potential hazards will be necessary or practical”
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All potential biological hazards identified should be evaluated
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“…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
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All potential biological hazards identified should be evaluated
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
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Tests deemed necessary to be based on end use of device
6
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Tests deemed necessary to be based on end use of device
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GLP Guidance
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Tests deemed necessary to be based on end use of device
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GLP Guidance
Include in vitro studies where possible
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Re-evaluate as necessary7
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Re-evaluate as necessary7
ExamplesChange in source of material
Change in processingChange in sterilization
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Re-evaluate as necessary7
ExamplesChange in source of material
Change in processingChange in sterilization
Follow-up testing may be necessary and amount can vary
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Consider all information for thorough overall assessment
8
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Consider all information for thorough overall assessment
8
Vendor information on materials
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Consider all information for thorough overall assessment
8
Vendor information on materials
Non-clinical tests
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Consider all information for thorough overall assessment
8
Vendor information on materials
Non-clinical tests
Post market experience
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To view the complete presentation on ISO 10993 Part 1
Check out NAMSA’s Seminars
You can view the entire ISO 10993 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 [email protected].
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