Medical devices
SLM GmbH is an independend third person as defined by EG-Guideline 2017/745 about medical devices 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 ISO 11138-7 and Ph.Eur. 5.1.2 - 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