Medical Device Biocompatibility Test
Biological Evaluation According to ISO 10993-1 & ISO 14971
Biological evaluation of a medical device shall be conducted within a risk management process acc. to ISO 14971. This involves the identification of biological hazards, the estimation of the associated biological risks, the determination of their acceptability and the implementation of risk control measures (ISO/FDIS 10993-1:2025). Biological evaluation shall consider both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle.
Our services include:
Basic FDA Biocompatibility-Readiness
✓ Cytotoxicity
- Standards: ISO 10993-5
Test:
Quantitative testing under ISO/IEC 17025 accreditation and GLP certification:
→ MTT Assay: TAT*: 4-5 weeks
Qualitative testing:
→ MEM Elution Test: TAT*: 4-5 weeks
✓ Sensitization
- Standards: ISO 10993-10, ASTM F2148
Test:
In vivo testing under ISO/IEC 17025 accreditation and GLP certification:
→ maximization test for delayed-type hypersensitivity:** TAT* 8-9 weeks
→ local lymph node assay (LLNA):** TAT* 12-13 weeks
✓ Irritation
- Standards: ISO 10993-23
Test:
In vivo testing under ISO/IEC 17025 accreditation and GLP certification: → intracutaneous irritation test: ** TAT* 6-7 weeks
→ dermal irritation test: ** TAT* 6-7 weeks
→ further in vivo irritation tests** (e.g. oral mucosa, ocular) on request
✓ Systemic toxicity
Standards: ISO 10993-11
Test:
In vivo testing under ISO/IEC 17025 accreditation and GLP certification: → acute systemic toxicity test* TAT* 6-7 weeks
→ further systemic toxicity tests* (subacute, subchronic) on request
→ material-mediated pyrogenicity test (rabbit), TAT* 6-7 weeks
✓ Genotoxicity Test
Standards: ISO 10993-3
Test:
In vitro testing under ISO/IEC 17025 accreditation and GLP certification:
→ Ames test, point mutation*; TAT* 3-4 months
→ chromosomal aberration test in human lymphocytes or V79 cells*; TAT* 6 7 months
→ micronucleus test in human lymphocytes or in V79 cells*; TAT*6-7 months
→ gene mutation test in mammalian cells*, HPRT test, point mutation; TAT* 4-5 months
→ gene mutation in mammalian cells **, mouse lymphoma assay, microtiter plate method; TAT* 4-5 months
In vivo testing under ISO/IEC 17025 accreditation and GLP certification:
→ chromosomal aberration assay in mammalian bone marrow*; TAT* 12 months
✓ Chemical Characterization
- Standards: ISO 10993-18
Test:
Chemical characterization under ISO/IEC 17025 accreditation:
→ volatile, semi-volatile and non-volatile organic E&L characterization: HS-GC-FID/-MS, GC-FID/ MS, LC-MS1; TAT* 4-8 weeks
→ sum parameter testing: TOC**, THC**, NVR**; TAT* 4 weeks
→ inorganic E&L: ICP-MS/-OES; TAT* 5 weeks
→ further analytical techniques: FTIR**, REM-EDX**; TAT* on request
✓ Degradation products from metals and alloys
Standards: ISO 10993-15
Test: Electrochemical corrosion testing under ISO/IEC 17025 accreditation:
→ potentiodynamic test
→ potentiostatic test
→ immersion test
TAT* 6-8 weeks
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
** Testing is performed under our coordination at GBA sister or partner laboratories under ISO/IEC 17025 accreditation and GLP certification.
Basic MDR Biocompatibility-Readiness
✓ Cytotoxicity
Standards: ISO 10993-5
Test:
Quantitative testing under ISO/IEC 17025 accreditation and GLP certification:
→ BCA (Protein) test; TAT* 3-4 weeks
Qualitative testing:
→ MEM Elution Test; TAT* 4-5 weeks
✓ Bloodcompatibility
Standards: ISO 10993-4
Test:
In vitro testing under ISO/IEC 17025 accreditation and GLP certification:
→ hemolysis test, extraction and direct contact method, use of human erythrocytes concentrate; TAT* 2-4 weeks
→ thrombogenicity test, use of fresh humen blood; TAT* 5 weeks
✓ Chemical Characterization
- Standards: ISO 10993-18
Test:
Chemical characterization under ISO/IEC 17025 accreditation:
→ volatile, semi-volatile and non-volatile organic E&L characterization: HS-GC-FID/-MS, GC-FID/ MS, LC-MS**; TAT* 4-8 weeks
→ sum parameter testing: TOC**, THC**, NVR**; TAT* 4 weeks
→ inorganic E&L: ICP-MS/-OES; TAT* 5 weeks
→ further analytical techniques: FTIR**, REM-EDX**; TAT* on request
✓ Degradation products from metals and alloys
Standards: ISO 10993-15
Test: Electrochemical corrosion testing under ISO/IEC 17025 accreditation:
→ potentiodynamic test
→ potentiostatic test
→ immersion test
TAT* 6-8 weeks
✓ Sensitization
Standards: ISO 10993-10, ASTM F2148, OECD 442D, 442E
Test:
In vivo testing under ISO/IEC 17025 accreditation and GLP certification:
→ local lymph node assay1 (LLNA)**; TAT* 12-13 weeks
→ maximization test for delayed-type hypersensitivity**; TAT* 8-9 weeks
In vitro testing under ISO/IEC 17025 accreditation and GLP certification:
→ LuSens Assay**; TAT* 4-5 months
→ h-CLAT Assay**; TAT* 4-5 months
✓ Irritation
Standards: ISO 10993-23
Test:
In vitro testing under ISO/IEC 17025 accreditation and GLP certification:
→ skin irritation test**, Reconstructed Human Epidermis Test method (RhE) test; TAT* 12-15 weeks
In vivo testing under ISO/IEC 17025 accreditation and GLP certification:
→ intracutaneous irritation test**; TAT* 6-7 weeks
→ dermal irritation test**; TAT* 6-7 weeks
→ further in vivo irritation tests** (e.g. oral mucosa, ocular) on request
✓ Systemic toxicity
Standards: ISO 10993-11
Test:
In vivo testing under ISO/IEC 17025 accreditation and GLP certification:
→ acute systemic toxicity test**; TAT* 6-7 weeks
→ further systemic toxicity tests** (subacute, subchronic) on request
→ material-mediated pyrogenicity test (rabbit),; TAT* 6-7 weeks
✓ Genotoxicity Test
Standards: ISO 10993-3
Test:
In vitro testing under ISO/IEC 17025 accreditation and GLP certification:
→ Ames test, point mutation**; TAT* 3-4 months
→ chromosomal aberration test in human lymphocytes or V79 cells**; TAT* 6-7 months
→ micronucleus test in human lymphocytes or in V79 cells**; TAT*6-7 months
→ gene mutation test in mammalian cells**, HPRT test, point mutation; TAT* 4-5 months
→ gene mutation in mammalian cells**, mouse lymphoma assay, microtiter plate method; TAT* 4-5months
In vivo testing under ISO/IEC 17025 accreditation and GLP certification:
→ chromosomal aberration assay in mammalian bone marrow**; TAT* 12 months
* estimated turnaround time (TAT) from receipt of the samples at the laboratory depending on medical device category. Individual test results are provided progressively. Additional services such as GLP documentation require one additional week.
** Testing is performed under our coordination at GBA sister or partner laboratories under ISO/IEC 17025 accreditation and GLP certification.
