This guideline is an aid to action based on the risk-based approach for the identification of critical impurities of a biological, chemical or particulate nature and, if necessary, for the definition of acceptance criteria (purity assessment) and for the inspection (purity determination) of medical devices in the manufacturing process. This applies both to the medical devices themselves and to their intermediate products, supplier products, etc. The initial reprocessing and reprocessing of medical devices on the user's premises and the assessment of the biological compatibility of medical devices (biocompatibility according to the standards in the ISO 10993 series) are not covered by this directive.
From the point of view of technical cleanliness, this directive is now for the first time a comprehensive description of tests of the particulate surface cleanliness of medical devices in the manufacturing process. The guideline is based on many years of experience in the automotive sector and describes largely the same test methods and test procedures, including qualification tests, in analogy to the well-known standards ISO 16232:2018 and VDA 19.1. In this sense, the verification of the specified acceptance criteria of particulate surface cleanliness is not new territory for manufacturers in the automotive sector, who are also involved in the production of medical devices or intermediate products. However, the risk-based determination of acceptance criteria remains the particular challenge in the medical technology sector, since there are no normative specifications here, but rather within the responsibility of the manufacturers or distributors must be determined by means of a risk assessment.
Furthermore, the biological and chemical purity of the products must also be evaluated. In all these questions CleanControlling Medical GmbH & Co. KG as an accredited and certified testing laboratory offers comprehensive test procedures for the microbiological-hygienic, biological, chemical and particulate surface cleanliness of medical devices.