The Element of Electrical Medical Product Compliance Required Elements for Certification
In order to certify your electrical medical product, the product must comply with the following standards. In addition, compliance reports for each standard are needed in preparation for, and as part of, the US-UL, CAN-CSA, & EU-CE product certification. When noted below, some of the elements are only required when provided and considered safety critical or used to mitigate risk.
- 1.
Risk Assessment (RA):
covering all potential risks including hazards identified in 60601-1 and any applicable 60601-2 particular standards (see below)
- 2.
Risk Management File (RMF):
contains all the documents utilized to document and demonstrate product quality and compliance including those referenced in the completion of the RMF Checklist.
- 3.
Risk Management File Checklist:
must be completed, providing details on how the product complies with ISO14971 and the RMF requirements within 60601-1. This is a long, detailed checklist. All documents referenced in the completion of the checklist should be in the Risk Management File.
- 4.
General Product Safety 60601-1:
1. Includes when applicable Programmable Electrical Medical systems per Section 14.
2. In the United States, the UL certification standard is published by AAMI and is titled AAMI ES 60601-1.
- 5.
Particular Standard(s) 60601-2-“X":
particular standards provide requirements for specific medical product types and product features. There is a long list of particular standards that should be reviewed for each new product. All applicable standards must be applied to the product. Some products have no particular standards.