Laboratory Testing Services

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ISO 10993-12, Ph.Eur. 2.2.44, USP 643, EN 1484
Chemistry - TOC (medical device) - analysis

72h extraction at 37°C or 50°C, TOC measurement of extract
ISO 10993-1, ISO 10993-12, ISO 10993-23
Biocomp - in vivo skin Irritation

Rabbit skin application, 4h exposure, 72h observation
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - direct contact

L929 cells, 24h direct contact, morphology assessment
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8270, EPA 525
Chemistry- GC screening - non-polar SVOC

Hexane extraction 72h at 37°C, GC-MS analysis
ISO 10993-7, ISO 10993-12
Chemistry - EtO/ECH residues - extra extraction

Additional extraction cycle for EO/ECH
ISO 10993-12, Ph.Eur. 2.2.44, USP 643, EN 1484
Chemistry - TOC (medical device) - method validation

Recovery study with sucrose spike in extraction water
ISO 10993-1, ISO 10993-10, ISO 10993-12
Biocomp - in vivo acute systemic toxicity

Mouse systemic injection, polar/non-polar extracts
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - indirect contact

Agar overlay method with L929 cells, zone assessment
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8270, EPA 525
Chemistry - GC screening - polar SVOC

Water extraction 72h at 50°C, GC-MS screening
ISO 10993-7, ISO 10993-12
Chemistry - EG residues

Ethylene glycol by GC-FID after extraction
ISO 10993-12, ISO 9377-2
Chemistry - Total Hydrocarbons (THC) - analysis

Hexane extraction 24h, GC-MS quantification
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664
Chemistry - LC screening - polar NVOC

Water extraction, LC-MS screening for non-volatiles
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - extract (XTT)

L929 cells exposed to extracts, XTT viability assay
ISO 10993-12, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169
Chemistry - ICP-MS screening (40 elements)

Water extraction, semi-quantitative scan for 40 elements
ISO 10993-12, ISO 10993-18, USP 467
IPA residual solvant testing

Extraction in DMF, GC-FID quantification
ISO 10993-12, ISO 9377-2
Chemistry - Total Hydrocarbon (THC) - method validation

Recovery validation with hydrocarbon standard, GC-MS method
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664
Chimie - LC screening - semi-polar NVOC

IPA extraction, LC-MS non-volatile screening
ISO 10993-1, ISO 10993-10, ISO 10993-12
Biocomp - in vivo sensitization - GPMT

Guinea pig maximization test, polar/non-polar extracts
ISO 10993-12, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169
Chemistry - ICP-MS analysis (1st element) - Base

Quantitative analysis for single element after extraction
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8260
Chemistry - GC screening - VOC

Water extraction 72h at 37°C, HS-GC-MS analysis
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664
Chemistry - LC Screening - non-polar NVOC

Hexane extraction, LC-MS analysis
ISO 11737-1, ISO 10993-1, ISO 10993-5, ISO 10993-12, ISO 10993-18, USP 71, USP 467
Complex Test Product UPDATED

GC-MS extraction method
ISO 10993-1, ISO 10993-12, ISO 10993-23
Biocomp - in vivo intracutaneous reactivity

Rabbit intradermal injection of polar/non-polar extracts
ISO 10993-12, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169
Chemistry - ICP-MS analysis (1 element) - Each additional element

Additional element quantification by ICP-MS
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8270, EPA 525
Chemistry - GC screening - semi-polar SVOC

IPA extraction 72h at 37°C, GC-MS screening
ISO 10993-7, ISO 10993-12
Chemistry - EtO/ECH residues

Simulated use extraction, GC-FID headspace analysis

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