Quality & Certificates

  • 21 CFR 177.1550.
  • 21 CFR 178.3297.
  • Meets the requirements of US Pharmacopeia Class VI.
  • BPSA/FDA leachables and extractables recommendations.
  • 3-A Sanitary Standards.
  • European Migration Directive 1935/2004.
  • ATEX Group IIA, IIB and IIC – area types 0,1 and 2 (in accordance to 1999/92/CE).
  • The quality management of Xtraflex NV, has been certified according to NBN-EN-ISO 9001:2015.

 

Electrical continuity

Tested in accordance with EN ISO 8031:2009 Clause 5, and complies to the requirements of Appendix A which states; Type M<102 Ω. Type Ω between 103 Ω and 108 Ω.

Anti-static quality

Tested in accordance with EN ISO 8031:2009 Clause 7 and complies to the requirements of Appendix A which state a resistance of between 103 Ω and 108 Ω between the inside of hose and an end fitting.

All Xtraflex products are build with very strict quality rules. In order for you to verify, we have bundled all our present certificates in this online book.

An example of all the available certificates. ISO 9001 CertificateISO 14001 Certificate