When this test applies
TOC is a screening measure rather than an ISO 10993-1 endpoint. It is used where a quick aqueous organic-load number is useful — cleaning validation, process-change checks, comparing lots or suppliers, and as a sanity check beside the ISO 10993-18 organic screens — and where a regulator or an internal specification asks for it.
When to run it
Whenever a cheap, fast comparison is needed: before and after a process change, across lots, or at the start of a chemistry programme to decide how much extractables work is warranted. At nine days it returns well before the compound-specific screens.
What the result tells you
Total organic carbon in the aqueous extract, reported as mg C per device or per mL and read against the threshold applied in the accompanying chemical or toxicological evaluation. TOC is a screening measure, not a pass/fail endpoint in its own right.
What it does not tell you
Nothing about which compounds are present — TOC is a sum, and a low number does not exclude a potent compound at low concentration. It also says nothing about inorganic extractables or about what non-aqueous solvents would extract, and it is not a substitute for ISO 10993-18 characterisation.
Method
The device is extracted in water per the O.I. Analytical protocol and the extract is analysed on a total organic carbon analyser by oxidation to carbon dioxide and detection. Additional dilutions, where the organic load requires them, are performed at an extra fee. Extraction ratio follows ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate.
Where it runs
Testing is performed to Groenakker protocols at an ISO/IEC 17025 accredited laboratory in Groenakker’s network, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Non-volatile residue in water as the gravimetric companion, and the VOC, SVOC and NVOC water screens when a compound-level picture is needed.
