Quality Assurances & Certifications

BS EN ISO 9001:2008

Aflex products are all manufactured in accordance with BS EN ISO 9001 Quality Management Systems independently assessed and registered by The British Standards Institution (BSI).

EN16643

Pharmaline N and X hose meets the requirements of EN 16643 (SC), which include the electrical and electrostatic requirements of hose assemblies.

TS16949

Aflex Hose Ltd manufactures PTFE flexible hose for the automotive industry in accordance with TS16949 and is assessed and certified by The British Standards Institution (BSI).

ISO 14001:2015

Aflex Hose Ltd have been successfully assessed to the requirements of ISO 14001, by the British Standards Institution (BSI). By gaining this accreditation Aflex Hose Ltd are demonstrating our commitment to reducing our impact on the environment.

USP Class VI and ISO 10993-5, 6, 10 and 11 guidelines

The Natural and Antistatic PTFE Hose Liners and the Platinum Cured Silicone Rubber Covers have been independently tested in accordance with USP protocols and are found to conform to the requirements of USP Class VI Chapter <88>.

Natural and Antistatic PTFE Hose Liners now also meet the more stringent USP Class VI and ISO 10993-6,10 and 11 guidelines at 121˚C (250˚F) with a “no reaction” classification.

Natural and Antistatic PTFE Hose Liners and Platinum Cured Silicone Rubber Covers have also been tested in accordance with USP protocols and are found to conform to the requirements of USP Class VI <87>, the L929 MEM Elution Test and are considered non-cytotoxic.

Natural and Antistatic PTFE Hose Liners have now been further tested and have passed the more stringent USP Class VI and ISO 10993-5 guidelines at 121˚C (250˚F).

USP <661> Physicochemical Test for Plastics

Natural and Antistatic (Carbon filled) Pharmaline N and X Externally Convoluted Smoothbore PTFE hose has been tested in accordance with USP Physicochemical Test for Plastics and found to meet the criteria of the following reference: USP34, NF 29, 2011. Monograph <661> Containers, Physicochemical Test-Plastics.

FDA

The Materials used to manufacture the natural PTFE Tube liner conforms to FDA 21 CFR 177.1550, and the antistatic PTFE liner conforms to FDA 21 CFR 178.3297.

3-A Sanitary Standards

Pharmaline N and X hose assemblies accredited to 3-A Sanitary Standards are identified within the product brochure. The Aflex Hose 3-A certificate is available to view on our website in the ‘certifications’ section.  The Aflex Hose 3-A certificate is also available to view on the 3-A Sanitary website .  Follow the link to the database search page and search for “Aflex Hose” under view company listings.

BPSA leachables and extractables testing

Aflex Hose Natural and Antistatic PTFE Hose Liner Tube has been independently tested in accordance with BPSA recommendations, and found to be satisfactory.

Copies of the Test Report are available for specific assessments to be made.

Pharmaceutical and Chemical Manufacturers Approvals

Most of the major pharmaceutical and Chemical manufacturing companies in the world have audited and/or approved Aflex Hose as a Hose Supplier.

CE Marking (Europe only)

Aflex has been assessed by The British Standards Institution (BSI) and found to comply with the Pressure Equipment Directive 2014/68/EU (European Community) Conformity Assessment Module D1, approved to CE Mark applicable hose products, accompanied by a Hose Usage Data Sheet, and a Declaration of Conformity.

Attestations of Conformity to ATEX Directive 2014/34/EU (Potentially Explosive Atmospheres)

Available for hose assemblies for components used in Gas Zones 1 & 2 and Dust Zones 21 & 22, when applicable.

Material Certification to EN10204

Available for all the hose or hose assembly components.

Certificates of Conformity to BS EN ISO/IEC 17050

Are available for all products.

Fuel Hose Approval to SAE J1737

Aflex Hose PTFE hose liners have been tested and approved to SAE J1737 for Automotive Fuel Hose applications.

Hose Testing

Each assembly is pressure tested to 2.0 times maximum working pressure before despatch, and pressure test certificates can be supplied.

Fire Resistance to BS5173 Section 103.13 Part 6.2 and 6.3

Pharmaline N and X hose assemblies are ‘Fire Resistant’. If DSI-300 is added at both ends, the assemblies are upgraded to ‘Fireproof’.

Food Contact

Manufactured in compliance with Regulation (EC) No 1935/2004 - on materials and articles intended to come in to contact with food, Commission regulation (EU) No 10/2011 - relating to plastic materials and articles intended to come into contact with food and Regulation (EC) No 2023/2006 - on good manufacturing practise for materials and articles intended to come in to contact with food.