OEM-production

The company advanced fiber tools GmbH offers its customers comprehensive application advice on the application possibilities of our products and the solution of customer-related problems.

advanced fiber tools GmbH
OEM customer
confidential agreement

product, technical file with customer specification

definition of the intended purpose and the essential requirements according directive 93/42/EWG Annex I

OBL contract

production of medical fibers by advanced fiber tools GmbH under following conditions/requests

  • quality management system according EN ISO 13485
  • CE-certification according directive 93/42/EWG Annex V
  • risk management according EN ISO 14971
  • applied materials according USP class VI, EN ISO 10993 ff
  • manufacturing in a clean room according class 100.000 (US-Norm Federal Standard 209 E) and class 8 (EN ISO 14644-1) respectively according GMP, Annex 1, class D
  • packaging medical fibers in sterile bags according EN ISO 11607-2
  • standard operating procedures for manufacturing, packaging and testing
  • ETO-sterilization based on a validation report according EN ISO 11135

delivery of medical fibers to OEM customer with following documents for each charge

  • declaration of conformity according directive 93/42/EWG
  • sterilization certificate according EN 556-1 optional certificates:
    endotoxin test (LAL test) according EP-BE: Ph. Eur. 5 Chapter 2.6.14, EO/ECH/EG - sterilization residual analysis according EN ISO 10993-7, BioBurden determination according EP-ME: Ph. Eur. 5 Chapter 2.6.12