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About Us » Certificates
the key to success
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 13485:2003 as well as Appendix II of the 93/42/EEC Guidelines is certified by the notified body of the TÜV Product Service GmbH Munich (Ref. Nr. 0123). There are annual audits to monitor these standards.

The CE label is a prerequisite for the free movement of medical products within Europe and is frequently adopted by other countries as the basic requirement for licensing these products.
In 2001, Pneumatik Berlin was granted a license to sell ceiling supply units in Canada. Since 2005 the product range is registered and licensed in Russia (GOST).