Certifications

The quality management of Xtraflex Ltd, has been certified according to:

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• BS-EN-ISO 9001:2015.

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• 21 CFR 177.1550.

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• 21 CFR 178.3297.

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• Meets the requirements of US Pharmacopeia Class VI.

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• BPSA/FDA leachables and extractables recommendations.

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• 3-A Sanitary Standards.

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• European Migration Directive 1935/2004.

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• ATEX Group IIA, IIB and IIC – area types 0,1 and 2 (in accordance to 1999/92/CE).

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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.

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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.

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Please contact our sales team if you require samples of our available certificates or wish to view our ISO certification.