Biomedical Engineering Reference
In-Depth Information
Table 9.4
Test matrix for implanted devices
Task/ISO testing requirement
(if developed as medical device
component)
Test for compliance
1) 10993-1/Pharmacopeia pyrogenicity
Rabbit pyrogenicity
2) 10993-3: Carcinogenicity
Qualify by literature (lit review/
risk assessment), or two year
implant study
3) 10993-3: Genotoxicity
Ames test, chromosomal
aberration study and
in vivo
mouse micronucleus study
4) 10993-3: Reproductive toxicity
Qualify by literature, or conduct
designated studies
5) 10993-4: Hemocompatability
Hemolysis - Direct contact
6) 10993-4: Hemocompatability
Coagulation
in vitro
7) 10993-4: Hemocompatability
Thrombogenicity
8) 10993-5: Cytotoxicity
Cytotoxicity - ISO elution
9) 10993-6: Local tissue tolerance/
implantation
Intracutaneous reactivity
10) 10993-10: Irritation / Intracutaneous
Intracutaneous reactivity
11) 10993-10: Sensitization
Guinea pig maximization study
or local lymph node assay
(LLNA)*
12) 10993-11: Acute systemic toxicity
USP/ISO Systemic injection test
13) 10993-11: Subchronic toxicity
Implant (injection) study in rats
3-9 months
14) 10993-13: Identifi cation of
degradation products from
polymeric medical devices
Immersion/extraction and
analysis of leached materials
15) 10993-15: Identifi cation of
degradation products from metals
and alloys
Immersion/extraction and
analysis of leached materials
17) 10993-16: Toxicokinetic study
design for degradation products
and leachables
Typically performed as a portion
of subchronic implant study
18) 10993-18: Chemical
characterization of materials
Varies
19) 10993-19: Physico-chemical,
morphological and topographical
characterization of materials
Varies
20) 10993-20: Principles and methods
for immunotoxicology testing of
medical devices
Varies - generally tier one
endpoints evaluated as part of
subchronic study
Notes
: All studies described above must be performed under GLP (Good
Laboratory Practices).
* In Japan, only the guinea pig maximization test (GPMT) is acceptable.
In Europe, the LLNA is preferred.
