Biological evaluation of medical devices - Standard NF EN ISO 10993-12 & 18

The NF EN ISO 10993-12 and -18 standards focus more specifically on the extraction of materials as well as the analysis techniques used to identify and quantify the elements that can be extracted in a medical device. This is the first step in biological risk assessment.
The most important point is to make sure to recover all the extractables . Proper preparation of samples and reference materials is important, and this preparation is governed by standard NF EN ISO 10993-12< .
The extraction conditions must be adapted to the nature and the use of the sample and the extraction time must respect precise values according to the temperature chosen.
The ISO 10993 standard defines 3 types of extraction, to be preferred according to the contact classes (devices with limited contact, devices with prolonged contact, devices with long-term contact)
1 / Simulated Extraction :
An extraction with use simulation is performed in order to estimate the type and quantity of substances assumed to be released by a medical device during its clinical use.
2 / Exaggerated Extraction :
Extraction intended to result in the release of a greater number or greater amount of chemical constituents than the amount produced under clinical conditions of use.
3 / Exhaustive Extraction :
Extraction in several stages carried out so that the quantity of extracted material found in a subsequent extraction stage represents less than 10% of that detected, by gravimetric analysis (or by any other means), during the initial extraction stage.

This last standard on which Polymex works allows the characterization and chemical quantification of extractables from medical devices by scanning a very wide spectrum of extractables: organic extractables, VOC ; Organic extractables , SVOC; Organic extractables , NVOC Elemental extractables

This characterization of extractables makes it possible in particular to obtain the information essential for carrying out the toxicological evaluation according to the ISO 10993-17 standard .

This characterization of the extractables makes it possible in particular to obtain the essential information for carrying out the toxicological assessment according to the ISO 10993-17 standard .

Other examples from industry

Determination of residual HCT / TOC in medical devices (Based on standards NF EN ISO 9377-2 and 1484)
Determination of residual HCT/TOC in medical devices

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Biological evaluation of medical devices - Standard 10993-7

Biological evaluation of medical devices - Standard 10993-7

Standards 10993-12 and 18 deal with the extraction of materials and analysis techniques allowing us to identify and quantify the elements..
10993 -12 & 18

10993 -12 & 18

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