The quality management of Xtraflex Ltd, has been certified according to:
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).
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.
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.
Please contact our sales team if you require samples of our available certificates or wish to view our ISO certification.