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Sterilization and Microbiology Testing for Medical Devices

Validated sterilization processes to eliminate or reduce the risk of infections.

Sterile surgical equipment laid out on a tray in an operating room

Overview

Sterilization and Microbiology Testing for Medical Devices is important as medical devices contaminated with pathogens may be a source of infection for humans. According to the Medical Device Directive, devices must be designed and manufactured in such a way as to eliminate or reduce the risk of infections to patients and other users. 

Our team offers expert evaluations in: 

Cleaning, sterilization and reprocessing 

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

  • Cleaning and sterilization of medical devices delivered in a sterile state 
  • Cleaning, reprocessing and sterilization of reusable medical devices (ISO 17664) 

Both product categories use validated sterilization processes that can only be applied to devices that are clean and disinfected. Cleaning and disinfection are therefore prerequisites for any effective sterilization process. All processes need to be subjected to validation studies. 

Microbiology 

Medical device manufacturers, 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 all 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 tests of UL MDT inform the manufacturer about the microbiological status of products, determine anti-infective properties of materials and disinfectants, and help to control manufacturing processes and sterilization procedures. 

Tests can be performed in a UL-accredited lab, and we can work with you on a combination of different tests as 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 

Why UL 

Global Market Acceptance  

  • More than 125 years in operation  
  • Working in more than 143 countries  
  • Our reports and certifications are recognized and accepted around the world 
  • UL Marks appear on more than 22 billion products globally

Comprehensive testing and certification services  

  • UL offers field evaluations and on-site training, and can come to you for testing 
  • Full compliance testing/evaluation to prescans and other preliminary testing  
  • Our engineers will work with you to set up a testing program that will help you verify compliance through the product conception and production phases  
  • Our engineers average more than 10 years in the industry 
  • We have more than11 industries business units in the UL company portfolio 

Knowledge of global standards and regulatory requirements 

  • Covers many markets, i.e., U.S. Food and Drug Administration, Korean Ministry of Food and Drug Safety, European Union (EU) In Vitro Diagnostics, EU Medical Device Directive 
  • We have helped to set more than 1,600 standards defining safety, security, quality and sustainability 
  • Our engineers partner with standard committees, such as AAMI, ANSI and government bodies 
  • We have an FDA-recognized consensus standard, UL 2900, for cybersecurity  

State-of-the-art facilities 

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

Related standards 

ISO 17664:2017 

EU Medical Device Directive 

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