just got an announcement this morning that NAMSA was the first biocompatibility test lab that received FDA's approval as an ASCA test lab under the
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Guidance. They got approval for the ASCA program on July 23. I am sure there are other Biocompatability labs in the wings that should follow shortly. The big reason for the delay in Biocop labs getting approval was the ISO 17025 accreditation which none of them had that. So, they all had to work thru that process. MOst of the safety test labs already had that and so you can see there are many test labs in the ASCA program. Please make sure the standard(s) that apply to your product(s) are included in the list of standards approved for the lab you will be using other wise use a different lab. You can check that in their approval at the
ASCA lab list.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------