Direkt zum Inhalt

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
Engl. VDI-Gesellschaft Bauen und Gebäudetechnik
Related manuals
Number of pages
Available in
German, English

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).

View Table of Contents (PDF file)

Purchase VDI Standard

Price from
219,10 EUR VAT included
Purchase now


Ask a question / Contact us

Development mode active. Do not expect the captcha to appear