Professional Testing can navigate the growing worldwide FDA 510(k) EMC medical requirements of IEC 60601-1-2.
Coupled with our Product Safety/NRTL approvals, PTI becomes your one-stop service provider to bring your medical product to market. The EMC requirements are similar to those described on our Commercial EMC Services page, but incorporate more stringent limits and criteria. This provides additional protection to medical patients and the sensitive equipment utilized in hospitals and healthcare facilities. Along with these evaluations, PTI can start by developing the Risk and Hazard Analysis for your new product.
|UL 60601||Medical Equipment|
|IEC 14971||Application of Risk Management to Medical Devices|
|*CDRH 21, CFR||Laser Products|
|UL XXXX||Although we specialize in the above standards, there are many more we can evaluate product to, just ask.|
The Center for Devices and Radiological Health (CDRH), a division of the Food and Drug Administration (FDA), regulates laser products imported to or manufactured in the United States. When submitting a product containing a laser through an NRTL for use in the United States or Canada, it may be necessary to evaluate your product for laser safety in accordance with CDRH 21, CFR or CSA E60825 respectively. PTI can evaluate your product to CDRH 21, CFR or CSA E60825 and assist you with the required documentation for compliance with these standards.