quality statement


advanced fiber tools GmbH Mittweida operates a process-oriented quality management system in accordance with EN ISO 13485 and a quality assurance system in accordance with EC directive 93/42/EEC, Appendix V. Medical products produced and supplied by advanced fiber tools GmbH are subject to the most stringent quality assurance criteria. Medical products produced and supplied by advanced fiber tools GmbH comply with EN ISO 10993-1 requirements in respect of their biocompatibility, depending on the respective purpose. Our products are delivered sterile on customer request. To this purpose we have a partner who guarantees a validated ETO sterilization process in accordance with DIN EN 550.

The following are available for our products:

  • Certification of sterilization in accordance with EN 556
  • Certified free of endotoxin (LAL test according to EP-BE: Ph. Eur. 5 Chapter 2.6.14)
  • ETO residual gas analysis in accordance with EN ISO 10993-7
  • Bioburden determination in accordance with EP-ME: Ph. Eur. 5 Chapter 2.6.12

Materials used in the production of our medical products meet, for example, requirements relating to USP class VI, EN ISO 10993-1, EN ISO 10993-5 and ASTM. No materials containing latex are used. Materials used for packing our products all meet DIN EN ISO 11607 and DIN EN 868 requirements. We realize reproducible ambient conditions in production (clean-room category D in accordance with the EU GMP Guide, Annex 1 or 100.000 in accordance with the US Federal Standard 209 E norm and ISO category 8 in accordance with EN ISO 14644-1). Clean-room monitoring processes are carried out regularly by a laboratory accredited by the national approval authority (ZLG in Germany). Our production is carried out in validated processes, e.g. for the execution of adhesive joints and for calibrated measuring and testing equipment for products and processes.

clean room

Trennlinie
Siegel: Made in Germany
CE 0483 EN ISO 13485 2003
Trennlinie