Cleanroom Assembling of medical laser probes

Medical laser probes place the highest demands on cleanliness, process reliability, and traceability.

We, advanced fiber tools, assemble customized laser probes in a particle and germ-controlled cleanroom environment—using standardized, documented processes from manufacturing and inspection through to packaging.

Standards, Processes, and Validation -presented transparently

Our medical laser probes are manufactured under clearly defined conditions and requirements—from quality management and process risk management to the use of biocompatible materials, cleanroom classification, sterile barrier systems, and validated sterilization processes:

  • Quality management system in accordance with EN ISO 13485
  • Risk management in accordance with EN 14971 and Regulation (EU) 2017/745.
  • Use of biocompatible materials in accordance with USP Class VI and EN ISO 10993
  • Manufacturing in a particle and germ-controlled environment in cleanrooms of the following cleanliness classes:
    - ISO Class 8 in accordance with EN ISO 14644-1,
    - Grade D in accordance with the EU GMP Guide, Annex 1, or
    - Class 100,000 in accordance with the U.S. Federal Standard 209E
  • Packaging of medical devices in sterile barrier systems in accordance with EN ISO 11607-1 and EN ISO 11607-2
  • Standardized processes for manufacturing, inspection, and packaging
  • Validated EO sterilization process in accordance with EN ISO 11135 (in cooperation with qualified service providers) 

Documentation for your
approval processes

To enable you to carry out your internal testing and approval processes efficiently and to track compliance transparently, we offer to supply you with the necessary batch-related documents and certificates, depending on the project and agreement:

  • EC Declaration of Conformity
  • Certificate of Conformity for each delivered batch
  • Sterilization certificate in accordance with EN ISO 11135
  • Test report for the determination of microorganisms on the products prior to sterilization (bioburden test) in accordance with EN ISO 11737‑1 (testing performed by an accredited laboratory)
  • Test report for the determination of endotoxins on the products after sterilization (LAL test) in accordance with the European Pharmacopoeia, United States Pharmacopeia USP 41–NF 36, and ANSI/AAMI ST72 (testing performed by an accredited laboratory)