Medical devices contaminated with pathogens may be a source of infection for humans. Therefore, according to the Medical Device Directive, devices must be designed and manufactured in such a way as to eliminate or reduce the risk of infection to the patient, user or third parties as far as possible.

Device Cleaning, Sterilization and Reprocessing

The requirements of device cleaning, reprocessing and sterilization procedures of medical devices can be divided into two product categories:

  1. Medical device cleaning, sterilization, and delivery in a sterile state
  2. Cleaning, reprocessing and sterilization of reusable medical devices (ISO 17664)

Both product categories have in common that device cleaning validation testing can only be applied to devices which are clean and disinfected. Cleaning and disinfection are therefore prerequisites for any effective sterilization process. All processes need to be subjected to cleaning validation studies.

Microbiology Device Testing and Status

Medical device manufacturers, in particular if they manufacture sterile devices, must produce their products under adequate and microbiologically monitored conditions involving a clear zone concept. Furthermore, the final products, and if necessary the starting and packaging materials, must be subjected to bioburden determinations in order to support the later sterilization success. For devices with an invasive application endotoxin testing is necessary in order to evaluate the potential risk that the device may cause fever reaction during application.

The microbiological basic validation testing of “UL Medical Device Testing (MDT)” inform the manufacturer about the microbiological status of their products, determine anti-infective properties of materials and disinfectants and help to control manufacturing processes and sterilization procedures.


The cleaning validation testing can be performed in a UL accredited lab and we can work with you on a combination of different testing needed.

  • Cleaning and sterilization of medical devices delivered in a sterile state
  • Cleaning, reprocessing and sterilization of reusable medical devices
  • Validation of sterilization processes
  • Bioburden Determinations
  • Differentiation and Detection of Pathogenic Microorganisms
  • Endotoxin Testing (LAL Test)
  • Antimicrobial Activity Testing
  • Microbiological Monitoring of Production



Global Market Acceptance

  • 120 year business experience
  • Operates in more than 143 countries
  • UL has issued more CB Test Certificates than any other body
  • UL reports and certifications are recognized and accepted around the world
  • UL Marks appear on more than 22 billion products globally
Comprehensive Testing & Certification Services

  • UL offers field evaluations, onsite training and can come to you for testing
  • Full compliance testing/evaluation to pre-scans and other preliminary testing
  • UL has engineers that work with you from design through conception and production
  • UL’s engineers average 10 plus years in the industry
  • UL has over 11 industries business units in the UL company portfolio


Knowledge of Global Standards and Regulatory Requirements

  • Covers many markets ie FDA (US), MFDS (Korean FDA), EU IVD, EU MDD
  • UL has helped to set more than 1,600 standards defining safety, security, quality and sustainability
  • UL Engineers partner with standard committees such as AAMI, ANSI and government bodies
  • UL has an FDA recognized consensus standard, UL 2900, for cybersecurity
State of the Art Facilities

  • 159 UL laboratories for testing and certification world wide
  • Tailored testing solutions, using software automation to enhance process efficiency, analyze results and reduce testing cycles
  • Over 10 Accredited UL laboratories around the world