Laboratory Testing Services

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ISO 10993-1, ISO 10993-10, ISO 10993-12
Biocomp - in vivo acute systemic toxicity

Mouse systemic injection, polar/non-polar extracts
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, 100606, 1006061, 1006062, 1006063, 1006071, 1006234, 10062341, 1006235, 1007018
Chemistry - LC Screening - non-polar NVOC

Hexane extraction, LC-MS analysis
EN 1186-13, ISO 6588-1, ISO 11607, 1002114, 1002115, 1002120, 100603, 100711, 100801, 100808, 100809, 100810, 100820, 100821, 100830, 100840, 100841, 100850, 100851
Packaging - PH test on packaging - extra sample

Additional sample pH test
USP 88
Biocomp - USP Class VI - Acute systemic toxicity

Mouse systemic toxicity per USP Class VI requirements
ISO 10993-18, 100606, 1006061, 1006062, 1006063, 1006071, 1006234, 10062341, 10062342, 1007011, 1007018
Chemistry - FTIR analysis for material identification

ATR-FTIR spectrum comparison with reference
USP 88
Biocomp - USP Class VI - Intramuscular implantation test

Rabbit muscle implantation, histopathology evaluation
ISO 10993-7, ISO 10993-12
Chemistry - EtO/ECH residues

Simulated use extraction, GC-FID headspace analysis
USP 88
Biocomp - USP Class VI - Intracutaneous test

Rabbit intracutaneous reactivity test with extracts
EPA 8270, EPA 525, 1007021
Chemistry - Phthalates - Solid

Solvent extraction, GC-MS for 13 phthalate esters
ISO 10993-1, ISO 10993-4
Biocomp - Hemocompatibility - Hemolysis (material induced)

Direct/extract contact with RBCs, hemoglobin release
ISO 10993-7, ISO 10993-12
Chemistry - EtO/ECH residues - extra extraction

Additional extraction cycle for EO/ECH
ISO 10993-1, ISO 10993-23, 1001106, 1001108
Biocomp - In Vitro Irritation Test (Medical device 10993-23)

MatTek EpiDerm™ reconstructed human epidermis model
ISO 10993-18, USP 231, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 1002119, 100421, 1006071, 1006072, 1006073, 1007030, 100706
Chemistry - Tenax Specific migration - Full package testing

Acid digestion, ICP-MS for heavy metals
Ph.Eur. 2.9.19, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169, USP 788, ISO 21501-3, AAMI TIR42, 1001105, 1001106, 1001107, 1001110, 1001111, 1001124, 1001125, 100405, 100423, 1007023, 1007030, 100706
Cleaning - Sub-visible particles - USP 788, EP 2.9.19 - analysis

Extraction in particle-free water, light obscuration counting
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, 100606, 1006061, 1006062, 1006063, 1006071, 10062341, 10062342, 1006235, 1007018
Chemistry - LC screening - polar NVOC

Water extraction, LC-MS screening for non-volatiles
ISO 10993-7, ISO 10993-12
Chemistry - EG residues

Ethylene glycol by GC-FID after extraction
Ph.Eur. 2.9.19, USP 788, ISO 21501-3, AAMI TIR42, 1001108, 1001109, 1001113, 1001116, 1001124, 1001125, 100405, 100421
Chemistry - Sub-visible particles - USP 788, EP 2.9.19 - method validation

Method validation with count standards at 10µm and 25µm
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, 1001124, 1001125, 100606, 1006061, 1006062, 1006063, 1006071, 1006234, 10062342, 1006235, 1007018
Chimie - LC screening - semi-polar NVOC

IPA extraction, LC-MS non-volatile screening
EN 1186-13, ISO 6588-1, ISO 11607, 1002114, 1002115, 1002120, 100603, 100711, 100802, 100808, 100809, 100810, 100820, 100821, 100830, 100840, 100841, 100850, 100851
Packaging - pH test on packaging

Cold water extraction, pH measurement

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