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Microbiology Lab for Implants (Plates and screws)

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Guest user Created:   Oct 25, 2021 Last commented:   Oct 26, 2021

Microbiology Lab for Implants (Plates and screws)

Could you please help me to understand the requirements for the microbiology lab requirements for Orthopaedic Implants (Screw, Plates and Knees) to be complied with ISO 13485 and MDR 745 Requirements.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Oct 26, 2021

The main point here is that these medical devices must be sterile. So I assume they are produced in a cleanroom. Microbiology requirements then include the following:

  • Microbiology monitoring of the environment (surfaces, air, workers hand, machines that are used in the cleanroom)
  • Bioburden before sterilization so that you know what is the microbiological load of your products to know which sterilization method to choose
  • Testing the sterility of your product after the sterilization

All of this is stated in the following standard:

  • EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

The microbiology laboratory for performing all this work must be accredited. It is stated in the MDR 2017/745, Article 106 - Article 106 – Provision of scientific, technical, and clinical opinions and advice – that the EU Commission designated the expert laboratories. Accreditation is one way how a laboratory can be designated.

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Oct 25, 2021

Oct 26, 2021