As a producer of medical products Pneumatik Berlin GmbH PTM has to be certified in accordance with the EU Guidelines on Medical Products 93/42/EWG Appendix II.
This certification in line with International Standard EN ISO 13485 (formerly DIN EN ISO 9001 and DIN EN 46001) was granted first in 1998 and, within their own sphere of responsibility, entitles Pneumatik Berlin to use this assessment process to declare conformity for ceiling supply systems and medical gas supply installations and, where appropriate, to label the products with the CE mark.
The quality management system according to EN ISO 13485:2016 is certified by the notified body of the TÜV Product Service GmbH Munich (Ref. Nr. 0123). There are annual audits to monitor these standards.