VDI 2083 Blatt 21
Cleanroom technology - Cleanliness of medical devices in the manufacturing process
At a glance
- German title
-
Reinraumtechnik - Reinheit von Medizinprodukten im Herstellungsprozess
- Publication date
- 2019-10
- Publisher
- Engl. VDI-Gesellschaft Bauen und Gebäudetechnik
- Related manuals
- Number of pages
- 108
- Available in
- German, English
- Abstract
-
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 series of standards ISO 10993).