To apply for a European government contract to supply our products it needed to be tested to and meet the requirements of EN12182.
We are using a internationally recognized test laboratory in Germany. The last time we tested these materials was in late 2011 to early 2012, those test reports were submitted and later rejected due to being over 3 years old?
I am/was trying to find out if in fact there is such a rule (in Europe)that reports expire after 3 years, it is not stated in EN12182 or any of the other standards I looked into?
Also our class 1 products are not exempt from US
510k requirements and have to meet MDD 93/42 class 1 medical device requirements. Even though as class 1 you can self certify , when you submit to government agencies you have to have certifications from accredited test facilities. There are specific ISO and EN standards that have to be meet, EN12812 and or 12183 and ISO 7176 series.
In this case it is not a big deal as both products use the same materials, but retesting of all products including subsequent bio and flammability testing every 3 year could get very expensive. If there has been no change to a standard or to the product that would affect the safety or intended use of a product I don't see the need to retest only because of an arbitrary 3 year time period that someone set.
But thanks for the feedback
Don