Biocompatibility Testing Sample Requirements

- Test Description
- Choose Test Description
- Cytotoxicity Tests
- Sensitization Tests
- Extractions for MHLW (Japan)
- Irritation
- Systemic Toxicity
- Genotoxicity
- Hemocompatibility
- Implantation
- Extractables & Leachables
  Sample Type: 3 Extracts
  Method: ISO 10993-18
- Direct Contact Method
  Sample Type: Liquid/Semi-Solid or 1 Extract
  Method: USP <87>
- Nuetral Red Uptake (NRU) - Elution or Direct Contact
  Sample Type: Liquid/Semi-Solid or 1 Extract
  Method: ISO 10993-5
- XTT Dye Method - Elution or Direct Contact
  Sample Type: Liquid/Semi-Solid or 1 Extract
  Method: ISO 10993-5
- MTT - Elution or Direct Contact
  Sample Type: Liquid/Semi-Solid or 1 Extract
  Method: ISO 10993-5
- MEM Elution Method
  Sample Type: Liquid/Semi-Solid or 1 Extract
  Method: ISO 10993-5; USP <87>
- Maximization Test (GPMT)
  Sample Type: 2 Extracts
  Method: ISO 10993-10
- MHLW MaximizationTest (GPMT)
  Sample Type: Exaggerated Extraction
  Method: MHLW
- Murine Local Lymph Node Assay (LLNA)
  Sample Type: 2 Extracts
  Method: ISO 10993-10
- Buehler Method
  Sample Type: Fabric
  Method: ISO 10993-10
- Preliminary Test
  Sample Type: Extraction in Acetone and Ethanol
  Method: MHLW
- Main Test Extraction with Method 1 or 2
  Sample Type: Extraction in Acetone or Ethanol
  Method: MHLW
- Intracutaneous Reactivity
  Sample Type: 2 Extracts
  Method: ISO 10993-10
- Primary Eye Irritation (72 hrs.)
  Sample Type: 2 Extracts
  Method: ISO 10993-10
- Intracutaneous Reactivity
  Sample Type: 4 Extracts
  Method: USP <88>
- Primary Skin Irritation (72 hrs.)
  Sample Type: 2 Extracts
  Method: ISO 10993-10
- Buccal Mucosa w/ Histo. (48 hrs.)
  Sample Type: 2 Extracts
  Method: ISO 10993-10
- Acute Systemic Toxicity
  Sample Type: 2 Extracts
  Method: ISO 10993-11
- Subacute Systemic Toxicity
  Sample Type: Liquid/Semi-Solid or Extract
  Method: ISO 10993-11
- Subchronic Systemic Toxicity
  Sample Type: Liquid/Semi-Solid or Extract
  Method: ISO 10993-11
- Chronic Systemic Toxicity
  Sample Type: Liquid/Semi-Solid or Extract
  Method: ISO 10993-11
- Material Mediated Pyrogen
  Sample Type: 1 Extract (Polar Only)
  Method: USP <151>
- Ames Mutagenicity Test (1 concentration of each extract)
  Sample Type: 2 Extracts
  Method: ISO 10993-3 & 33; OECD 471
- Ames Mutagenicity Test (5 concentration of each extract)
  Sample Type: 2 Extracts
  Method: ISO 10993-3 & 33; OECD 471
- MLA Lymphoma Forward Mutation Assay
  Sample Type: 2 Extracts
  Method: ISO 10993-3; OCED 490
- Chromosomal Aberration Assay
  Sample Type: 2 Extracts
  Method: ISO 10993-3; OECD 473
- In Vivo - Peripheral Blood Micronucleus Test (Limit Test)
  Sample Type: 2 Extracts
  Method: ISO 10993-3 & 33; OECD 474
- ASTM Hemolysis (Static Design)
  Sample Type: Blood Contact
  Method: Direct Contact - ASTM F756
- ASTM Hemolysis (Static Design)
  Sample Type: Blood Contact
  Method: Extract Method - ASTM F756
- Hematology (Static Design); Platelet and Leukocyte
  Sample Type: Blood Contact
  Method: ISO 10993-4
- Partial Thromboplastin Time (PTT)
  Sample Type: Blood Contact
  Method: ISO 10993-4
- Complement Activation (SC5b-9)
  Sample Type: Blood Contact
  Method: ISO 10993-4
- Thrombogenicity
  Sample Type: Blood Contact
  Method: ISO 10993-4
- Class VI (Implantation, Acute Sys. Tox, Intracut. Reac.)
  Sample Type: Multiple Extracts
  Method: USP <88>
- Intramuscular, 5 Days of Implantation
  Sample Type: Implant
  Method: USP <88>
- Subcutaneous, 7 Days of Implantation
  Sample Type: Implant
  Method: USP <88>
- Subcutaneous, Muscle or Bone (4 week) w/ Histo
  Sample Type: Implant
  Method: 10993-6
- Subcutaneous, Muscle or Bone (13 week) w/ Histo
  Sample Type: Implant
  Method: 10993-6
- Subcutaneous, Muscle or Bone (26 week) w/ Histo
  Sample Type: Implant
  Method: 10993-6
- Subcutaneous, Muscle or Bone (52 week) w/ Histo
  Sample Type: Implant
  Method: 10993-6
- Thickness Ratio
  - < 0.5 mm Thickness Ratio: 6 cm2/mL
  - ≥ 0.5 mm Thickness Ratio: 3 cm2/mL
- Sample Requirements
- 4 devices (120 cm2 each)
- 8 devices (120 cm2 each)
- 1 device (72 cm2)
- 1 device (36 cm2)
- 6 devices (120 cm2 each)
- 6 devices (60 cm2 each)
- 6 devices (60 cm2 each)
- 6 devices (30 cm2 each)
- 140 Fabric Samples (2.5 cm x 2.5 cm)
- 10 grams
- Method 1 - TBD; Method 2 - 25 grams
- 2 devices (120 cm2 each)
- 2 devices (60 cm2 each)
- 2 devices (36 cm))
- 1 device (18 cm2)
- 4 devices (90 cm2 each)
- 4 devices (60 cm2 each)
- 2 devices (36 cm2 each)
- 2 devices (18 cm2)
- 3 devices (36 cm2 each)
- 3 devices (18 cm2 each)
- 2 devices (120 cm2 each)
- 2 devices (60 cm2 each)
- TBD
- TBD
- TBD
- 900 cm2
- 450 cm2
- 2 devices (60 cm2 each)
- 4 devices (30 cm2 each)
- 2 devices (240 cm2)
- 2 devices (120 cm2)
- 2 devices (120 cm2 each)
- 2 devices (60 cm2 each)
- 3 devices (60 cm2 each)
- 3 devices (30 cm2 each)
- 3 devices (60 cm2 each) requires predicate device
- 6 cm2
- 3 cm2
- 2 devices requires predicate device
- 8 devices (90 cm2 each)
- 8 devices (45 cm2 each)
- Enough material for 8 implants that are 10-12 mm x 1-3 mm
- Enough material for 10 implants that are 10-12 mm in diameter x 0.3-1 mm
- 15 samples per time point, each sample 10 mm x 1-3mm
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* The results of the above calculator are only recommendations. It is necessary to verify the results with company representatives

Biocompatibility Testing Sample Requirements

Test Description

Sample Requirements

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