Revision of ISO 10993-18: FILAB incorporates the AET concept into its chemical characterization processes for medical devices.
The revision of ISO 10993-18:2019 on the physicochemical characterization of materials associated with medical devices is due to be published shortly (expected in the last quarter of 2019), and medical device manufacturers have every interest in incorporating the changes now to avoid having to repeat their chemical characterizations when it comes into force.
Although the analytical approach remains broadly the same, this revision clarifies many points—particularly regarding extractables characterization—and introduces new concepts such as the AET.
The AET defines a limit for the quantification or detection threshold of analysis performed as part of this assessment.
According to the draft ISO 10993-18:2019 standard, the AET is calculated as follows:
To best support you during this regulatory transition, FILAB now includes AET calculation in its chemical characterization services for materials in accordance with ISO 10993-18.
Please note that FILAB is the 1st laboratory to obtain COFRAC 17025 accreditation according to ISO 10993-18! This complements our COFRAC ISO 17025 accreditations for medical devices covering TOC/TC analysis and inorganic residue analysis by ICP according to ISO 19227 (More information at www.cofrac.fr – accreditation no. 1-1793).
FILAB also supports you with the following services:
Our services
Problem-solving through failure analysis: non-conformity, breakage, adhesion, corrosion...
Process validation: Cleaning (ISO 19227), surface treatment
