PER 2000 News
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In November 2009 the manufacturer of the PER 2000 received the final report of the notified body TUV Sud USA (NB 1929) in San Diego. The main message of this report was that Pulsed Energy Technologies is now certified as a manufacturer of medical devices by ISO 13485 and corresponding certificate was issued. See the document by clicking the page certifications.
This certification is the basic precondition to apply for the CE approval. We passed all tests already (CE, EMC, security etc.) with positive results in compliance with the european directives 93/42/EEC following MPG.
During the examination of the EMC testimonial of the PER 2000 the TUEV detected that one value was a little bit over the default limit. But the guideline for the European approval contains an exception for such devices that produce a magnetic field. Our PER 2000 belongs definitely to this category. We engaged an appraiser for medival devices to clear this situation with the TUEV. We expect now a positive result soon.
18. April 2010
Important information for US visitors:
Pulsed Energy Technologies engaged the notified body Intertek to repeat all testings again. Intertek confirmed now compliance and certification of our PER 2000 to EMC standards in compliance with the european directive 93/42/EEC. Safety testing is underway. Final result is announced to be issued soon.
06. November 2010 - breaking news
NB 0979
03. January 2011 - breaking news
PER 2000 passed all tests for EMC in comliance with european directive 93/42/EEC! See Intertek Test Report on page Certifications.