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Particulate contamination analysis of medical devices
VDI: 2083 Residual Particulate Contamination in Medical Devices
From a technical cleanliness point of view, VDI guideline 2083 describes how to test for residual particulate contamination derived from the manufacturing process in medical devices.
This guide takes automotive standards as a reference and, with some exceptions, maintains the same test methods, procedures and techniques as those in ISO 16232 and VDA 19.1.
The determination of acceptance criteria and verification limits in the medical device industry is still a developing field. Manufacturers usually determine limits and aceptance criteria based on risk analysis and provide them to the laboratory for verification by testing.
Analytical techniques
Particulate contamination in medical devices is becoming an industry requirement. Manufacturers wish to ensure that their products are as safe and reliable as possible. In other words… could particulate contamination from the supplied product affect the patient?
For this type of product, the most used inspection standards are the automotive standards VDA 19.1 and ISO 16232, qualified and supplemented by the VDI 2083 guide “Purity of medical devices in the manufacturing process”.
To the standard particle counting and classification analysis, additional inspection techniques such as SEM-EDX or FT-IR can be added in the concept of process optimization for compliance with risk-based acceptance criteria. These analytical techniques allow material identification and assist in the investigation of potential causes of damage.
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