When this applies
ISO 10993-1:2025 routes the systemic, subacute, chronic, genotoxicity and carcinogenicity endpoints through chemical characterisation and an ISO 10993-17 assessment wherever the data allow, and reviewers expect that assessment to be written and signed by a qualified toxicologist. It applies to any device with ISO 10993-18 extractables or leachables data — your own, a supplier's, or a ChemTox package's — and to any submission where chemistry is being used to avoid an animal study.
When to commission it
As soon as the chemistry reports are in, and before any systemic or genotoxicity study is ordered — the assessment is what tells you whether those studies are needed. Allow three weeks from receipt of all inputs. Where the chemistry has not been run yet, a protocol (GRK-2005) written with the assessment in mind saves re-work.
What you receive
A toxicological risk assessment in Groenakker’s template or yours covering: review and interpretation of the chemical characterisation data; grouping of constituents into families; screening against REACH, ECHA SVHC, Annex XVII, Proposition 65 and FDA lists; assessment of every constituent against the ISO 10993-17 toxicological screening limit for the device's exposure; and documented conclusions for each biological safety endpoint. Signed by a DABT board-certified toxicologist.
What it does not cover
Constituents above the toxicological screening limit need a full evaluation — derivation of the estimated exposure dose, tolerable intake and margin of safety — which is GRK-2004, quoted per set of five constituents. The assessment cannot see what the chemistry did not detect, and it does not address sensitization, irritation, implantation or hemocompatibility. Urgent requests — delivery in fewer than three business days from receipt — are billed at the standard hourly rate in addition to the base price, and work outside standard business hours (Monday to Friday, 8:00 AM to 5:00 PM ET, excluding observed holidays) at two times the hourly rate; both are subject to availability and confirmed in writing before work starts.
Method
A toxicological risk assessment to ISO 10993-17:2023 turns your chemical characterisation data into an endpoint-by-endpoint safety conclusion, signed by a DABT board-certified toxicologist. A Groenakker toxicologist reviews the analytical reports for completeness, sensitivity and identification confidence; groups the constituents; screens them against the regulatory lists; calculates exposure from the device's intended use and contact duration; compares each constituent with the ISO 10993-17 toxicological screening limit; and documents the conclusions endpoint by endpoint. The report is reviewed and signed by a DABT board-certified toxicologist.
Who does the work
In-house at Groenakker. The assessment is prepared under Groenakker’s ISO 13485:2016 certified quality system and signed by a DABT board-certified toxicologist, and issued in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
Derivation of TI and EEDmax (GRK-2004) for constituents above the screening limit, the chemistry screens or a ChemTox package that generate the data, and the Biological Evaluation Report (GRK-1002) that carries the conclusion into the submission.
