Medical devices

SLM GmbH is an independend third person as defined by EG-Guideline 90/385/EWG and 98/75/EG

• Exchange-services for informations about our test results of medical devices.
  Example:Where are critical areas in the sterilization, cleaning and disinfecting process as well as when the product will be used later on and how could they be changed?
• Testing sterilizability and sterility
  in accordance with DIN EN ISO 11737-2 and Ph.Eur. 2.6.1
• Utilizing and evaluating bioindicators for the validation of sterilization processes
  in accordance with DIN EN 866, ISO 11135-1
• Determining the bioburden before sterilization
  in accordance with DIN EN ISO 11737-1
• Determining the product- and method-specific recovery rate (k-factor)
  in accordance with DIN EN ISO 11737-1
• Determining bacterial endotoxins with  LAL test
  in accordance with Ph.Eur. 2.6.14
• Testing for particulate contamination
  in accordance with DIN 8536, part 4, app.1.4.2
• Testing packaging material’s ability to maintain a sterile barrier
  in accordance with DIN 58953-6
• Monitoring clean rooms and production personnel
  in accordance with DIN EN ISO 14644 for particles, airborn and surface germs
• Training/seminars for production personnel
• AMES test
  in accordance with OECD guideline for the mutagenic potential of materials