Quality Assurance & Certification

EN ISO 9001:2015

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).

EN16643:2016

Bioflex Ultra meets the requirements of EN 16643 (SC), which include the electrical and electrostatic requirements of hose assemblies.

IATF16949:2016

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.

 

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 62-02

Bioflex Ultra hose assemblies accredited to 3-A Sanitary Standards are identified within the product brochure.

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 Manufacturers Approvals

Most of the major pharmaceutical 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 EN ISO/IEC 17050

Are available for all products.

OHSAS 18001:2007

Aflex Hose Ltd have been successfully assessed to the requirements of OHSAS 18001, by the British Standards Institution (BSI). By gaining this accreditation Aflex Hose Ltd are demonstrating our commitment to the health and safety of our employees by consistently identifying and controlling risks to health and safety, reducing the potential for accidents, complying to relevant legislation and improving overall awareness throughout the business

Hose Testing

Each assembly is pressure tested to 1.5 times maximum working pressure before despatch, and pressure test certificates can be supplied.

 

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.