procedure of OEM production for medical fibers

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 10993-1, ASTM
manufacturing in a clean room according class 100.000
(US-Norm Federal Standard 209 E)
and class 8 (EN ISO 14644-1) respectively
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 11135-1

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:
free of endotoxin (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

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CE Zertifikat

EN ISO 13485 Zertifikat

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