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The fourth session of our Electro-Medical Device webinar series will notify you of the different standards under 60601-1 concerning Safety and Performance along with Environmental Risks addressed in 60601-1-9.

Starts

Oct 15, 2014

Ends

Oct 15, 2014

Location

Online

Body Scan X-ray

The fourth session of our Electro-Medical Device webinar series will notify you of the different standards under 60601-1 concerning Safety and Performance along with Environmental Risks addressed in 60601-1-9.

The Risk Management Requirements in IEC 60601-1 (and the 60601 series in general) cover the specific RM requirements for electrical, energy and mechanical hazards.  It also addresses essential performance.

We will review:

  • Specific examples of RM requirements in IEC 60601-1
  • Common problems encountered in manufacturer’s RM files with respect to IEC 60601-1

Section 60601-1-9 of the standard requests identification of the materials and resources use throughout the life of the product. To do so, manufacturers are tasked to work with suppliers to know the composition of parts and document resources used.

Topics in this section will cover:

  • Developing an inventory of parts and materials
  • Estimating missing supplier/Bill of Materials data
  • Documentation  and declaration for conformance and disclose data to customers

Event Details:

Time: 3:00 – 4:00 pm Eastern Time

Cost: No Charge

 

CLICK HERE to view all of the other topics in this Electronic Medical Devices Webinar Series!