UV Sanitation Unit Certification

Goals

The goal is to outline the list of certifications required, names of the certifying bodies, government regulations, and consulting groups that can assist with certification of a medical-grade UV sanitizer unit.

Early Findings

Overview

  • Ultraviolet devices are listed in the FDA's classification system under regulation citation 21CFR as code "Part 880" and under the medical regulation number 80 denoting "general hospital" equipment. The specific code for reference is 21CFR880.6600.

Certifying Bodies

Certifications

  • A 60601-1 certification is required for medical devices which shows that the device meets the international regulatory standards for basic safety and performance. To obtain this certification, a risk analysis must be done on the equipment based on the ISO 14971, and then the results are submitted to a testing lab in the form of a risk management file. The lab will then test and evaluate the product.

Government Regulations

  • The code of federal regulations Title 21 includes the following section which outlines the regulations for UV disinfection devices: Sec. 880.6600 Ultraviolet (UV) radiation chamber disinfection device.
  • There are numerous basic regulatory requirements for manufacturers of medical devices that are distributed in the US. These requirements are as follows:
    • Establishment Registration
    • Medical Device Listing
    • Premarket Notification 510(k) or Premarket Approval
    • Investigational Device Exemption (IDE) for clinical studies
    • Quality System (QS) regulation
    • Labeling Requirements
    • Medical Device Reporting (MDR)

Consultancy Groups

Proposed next steps:

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