New from CertifiGroup: Read more about CPSC & CE

Toy and Child
Product Safety Testing

Fully accredited compliance lab CertifiGroup (CPSC, CE, ILAC-MRA, ACLASS, etc.) is now working directly with children's toy manufacturers to resolve common product safety testing issues such as flammability & lead or chemicals.

Testing to all
applicable standards

At CertifiGroup, we're an experienced & fully accredited test lab - no matter your testing needs, details, or urgency, we're confident we can help you get compliant.

Your trusted
product safety experts

Our engineering staff are some of the most experienced in the industry. Our experience comes from years of evaluating and testing systems, products and equipment of every category and type imaginable.

Download the whitepapers

Get the knowledge & understanding you need to know to get your products compliant - download our multi-part whitepaper series covering the top hazards of product safety now!

Weekly Whitepaper
Week #99
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. 1.
    Risk Assessment (RA): covering all potential risks including hazards identified in 60601-1 and any applicable 60601-2 particular standards (see below)
  2. 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. 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. 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. 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.
Weekly Whitepaper
Week #98
60601-1: MOPP vs. MOOP

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. 1.
    Risk Assessment (RA): covering all potential risks including hazards identified in 60601-1 and any applicable 60601-2 particular standards (see below)
  2. 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. 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. 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. 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.

Get help, and get compliant

Getting compliant on product safety regulations doesn't have to be hard. CertifiGroup is here to help. Let us guide you through the neccessary steps and get you to market faster today.