TOC Analysis in Medical Devices – Validation for Safety and Biocompatibility

TOC analysis (Total Organic Carbon) is an essential method within tıbbi cihaz analizleri to verify cleaning validation, rinse water purity and manufacturing contamination control. Medikal ürünlerde TOC analizi is performed in accordance with USP <643>, EP 2.2.44 and ISO 15883 standards. It is also required before biyouyumluluk analizleri to ensure no residual chemicals remain on medical device surfaces.

Why is TOC Analysis Important?

During tıbbi cihaz analizleri, manufacturing residues such as detergents, lubricants or chemical agents may remain on surfaces.
Medikal ürünlerde TOC analizi measures the organic carbon content to confirm cleaning effectiveness.
According to ISO 10993-18 and biyouyumluluk analizleri, TOC analysis supports chemical characterization and toxicological risk evaluation.

Standards Referenced

Standard	Description
USP <643>	TOC analysis for water and pharmaceutical systems
EP 2.2.44	Measurement techniques for organic carbon
ISO 15883	Cleaning validation for reusable surgical instruments
ISO 13485	Quality management system for medical device production
ISO 10993-18	Chemical characterization for biyouyumluluk analizleri

Example Results

Sample	TOC Result	Limit
Rinse water – surgical scissors	150 ppb	≤ 500 ppb
Medikal ürünlerde TOC analizi – catheter water	0.4 ppm	≤ 1.0 ppm
Process tank in gel manufacturing	0.25 ppm	≤ 0.5 ppm

These findings must be documented under medikal ürünlerde TOC analizi and tıbbi cihaz analizleri validation reports.

Conclusion

TOC analysis, medikal ürünlerde TOC analizi and tıbbi cihaz analizleri are critical for ensuring patient safety and product reliability. Combined with biyouyumluluk analizleri, it validates the chemical cleanliness of medical devices according to ISO 10993, USP and EP standards.

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TOC Analysis in Medical Devices – Validation for Safety and Biocompatibility