VDI 2083 Blatt 21:2018-08

This standard is a pracitcal aid based on a risk-based approach to identifying critical biological, chemical or particulate contaminations and, if required, to the specification of acceptance criteria (assessment of cleanliness) and for the verification (determination of cleanliness) of medical products in the production process. This applies both to the medical products themselves and to their intermediates, supplier products, etc. This standard does not cover the initial treatment and reconditioning of medical products by the user and the assessment of biological compatibility of medical products (biocompatibility as per ISO 10993 series of standards).