iso 10993-4 biological evaluation of medical devices - tests for interactions with blood
TRANSCRIPT
ISO 10993-4 Biological Evaluation of
Medical Devices: Tests for interactions with
blood
Joseph W. Carraway, DVM, MS
Scientific Director, Laboratory Services
NAMSA
2
ISO 10993-4 defines general requirements
for evaluating the interactions of medical
devices with blood and details:
3
ISO 10993-4 defines general requirements
for evaluating the interactions of medical
devices with blood and details:
Classification of medical and dental devices
intended for use in contact with blood based on the
intended use/duration
4
ISO 10993-4 defines general requirements
for evaluating the interactions of medical
devices with blood and details:
Classification of medical and dental devices
intended for use in contact with blood based on the
intended use/duration
Fundamental principles governing the evaluation
of the interaction of devices with blood
5
ISO 10993-4 defines general requirements
for evaluating the interactions of medical
devices with blood and details:
Classification of medical and dental devices
intended for use in contact with blood based on the
intended use/duration
Fundamental principles governing the evaluation
of the interaction of devices with blood
Rationale for selection of tests according to
specific categories, together with principles and
scientific basis of the tests
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Devices are divided into three categories
concerning blog contact.
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Externally Communicating Devices with Indirect
Blood Contact- Cannulae, blood collection sets, cell savers, etc.
Devices are divided into three categories
concerning blog contact.
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Devices are divided into three categories
concerning blog contact.
Externally Communicating Devices with Indirect
Blood Contact- Cannulae, blood collection sets, cell savers, etc.
Externally Communicating Devices with Direct
Blood Contact- Catheters, guidewires, hemodialysis equipment, etc.
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Devices are divided into three categories
concerning blog contact.
Externally Communicating Devices with Indirect
Blood Contact- Cannulae, blood collection sets, cell savers, etc.
Externally Communicating Devices with Direct
Blood Contact- Catheters, guidewires, hemodialysis equipment, etc.
Implant Devices- Heart valves, endovascular grafts, stents, etc.
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Five testing categories are listed based on the primary process or system being measured for blood interaction
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Five testing categories are listed based on the primary process or system being measured for blood interaction
Thrombosis
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Five testing categories are listed based on the primary process or system being measured for blood interaction
Thrombosis
Coagulation
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Five testing categories are listed based on the primary process or system being measured for blood interaction
Thrombosis
Coagulation
Platelets
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Five testing categories are listed based on the primary process or system being measured for blood interaction
Thrombosis
Coagulation
Platelets
Hematology
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Five testing categories are listed based on the primary process or system being measured for blood interaction
Thrombosis
Coagulation
Platelets
Hematology
Complement system
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After determining whether hemocompatability testing is required, the testing recommendations are defined based on the device categorization
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General
Recommendations5
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An appropriate model/system to simulate
the geometry and conditions of contact
should be implemented, when possible
1
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Since some of the methods don’t include
“pass/fail” criteria, consideration should
be given to include a relevant predicate
device
2
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The use of anticoagulants in both in vitro
and in vivo tests should be avoided,
unless this is part of the IFU for the
device
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Human blood should be used where
possible, however, the use of a test
model may also yield satisfactory results
4
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A sufficient number of tests, including
controls, shall be performed for the
statistical evaluation of data
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