Kuldeep Singh
Involved In Discussions
Hi Everyone.
As we are manufacture of Medical X-Ray equipment and Manufacture the Computed tomography Scan machine. As i new to this product and Compliance testing for this product is all under to me. When i saw the compliance table of predicate devices there i notice IEC 60601-1-9 which is (Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design)
So i am bit confusing for testing of our CT Scan machine for this particular standard.Is it mandatory to compliance with this standard also?
Thanks in advance
As we are manufacture of Medical X-Ray equipment and Manufacture the Computed tomography Scan machine. As i new to this product and Compliance testing for this product is all under to me. When i saw the compliance table of predicate devices there i notice IEC 60601-1-9 which is (Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design)
So i am bit confusing for testing of our CT Scan machine for this particular standard.Is it mandatory to compliance with this standard also?
Thanks in advance