PTFE HOSES (Aflex Hose)
BS EN ISO 9001:2008
Aflex products are all manufactured in accordance with BS EN ISO 9001: 2008 Quality Management Systems independently assessed and registered by The British Standards Institution (BSI).
EN 16643
Aflex Hose products fully comply with the European Norm EN16643 “Rubber and plastic hoses and hose assemblies – Non-Bonded fluoroplastic lined (e.g. PTFE) hoses and hose assemblies for liquid and gaseous chemicals – Specification”
This technical standard is for PTFE lined hose constructions that do not utilise adhesive to bond adjacent layers of material (e.g. PTFE to rubber). Key hose material properties, hose assembly performance requirements, liner types, dimensional classifications and electrical/electrostatic grades are contained within EN16643. More detailed information can be found within full product brochures.
ISO/TS 16949:2009
Aflex products for the Automotive Sector are all manufactured in accordance with ISO/TS 16949:2009 Quality Management Systems and independently assessed and registered 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
Natural and Antistatic PTFE Hose Liners, Platinum Cured Silicone Rubber Covers (White and Clear) and EPDM Rubber Cover (Blue) have been 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, Platinum Cured Silicone Rubber Covers (White and Clear) have also been tested in accordance with USP protocols and are found to conform to the requirements of USP Class VI Chapter <87>, the L929 MEM Elution Test and are considered non-cytotoxic.
USP <661> Physicochemical Test for Plastics
Natural and Antistatic (Carbon filled) 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 and AS (anti-static) 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
Aflex Hose have 3-A Sanitary Standards approval for Bioflex Ultra, Pharmaline N and Pharmaline X product lines when assembled with appropriate end fittings. Assemblies are marked with the 3-A logo and product code to match the coding presented on the Aflex Hose 3-A certificate. Full details of 3-A assembly availability is included within the relevant full product brochure.
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 Conformity Assessment Module D1, approved to CE Mark applicable hose products, accompanied by a Hose Usage Data Sheet, and a Declaration of Conformity.
Material Certification to EN10204
Available for all the hose or hose assembly components.
Hose Identification and Testing
All Aflex Hose assemblies are identified with a stainless steel identification tag, ring or ferrule, laser etched with a unique serial number for traceability, and other relevant information. Each assembly is pressure tested to 1.5 times maximum working pressure before despatch, and pressure test certificates can be supplied.
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.
Declaration of conformity, Plastic materials and articles intended to come in to contact with food
Aflex Hose Ltd declare that our PTFE flexible hose; Bioflex Ultra, Corroflon, Pharmaline N & X, Corroline+, Hyperline FX, Smoothbore and Bioflon in both natural (GP) and Anti-static (AS) forms are manufactured in compliance with the following laws, regulations and standards: Regulation (EC) No. 1935/2004; on materials and articles intended to come into 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 practice for materials and articles intended to come into contact with food.
Attestations of Conformity to Atex Directive 2014/34/EU (Potentially Explosive atmospheres)
Available for hose and assemblies for components used in Gas Zones 1 & 2 and Dust Zones 21 & 22, when applicable.
Certificates of Conformity to BS EN ISO/IEC 17050
Are available for all products.
Fuel Hose Approval to SAE J1737
Bioflex hose samples have been tested and approved to SAE J1737 for Automotive Fuel Hose applications.
Fire Resistance to BS5173 (Section 103.13 Part 6.2 and 6.3)
BK Grade Bioflex Ultra hose assemblies are “Fire Resistant”. If DRC-300 is added at both ends, the assemblies are upgraded to “Fire Proof”.
Modern Slavery Act 2015
At Aflex Hose , as a major manufacturer and supplier of PTFE flexible hose, we recognise the responsibility that we share with our suppliers, to buy raw materials and sell our products in an ethical manner. As part of this commitment we acknowledge our responsibility towards the Modern Slavery Act 2015 and will ensure transparency within the organisation and with our suppliers of goods and services to Aflex Hose.
REACH/ROHS Declaration
We declare that to the best of our knowledge and belief that articles we provide in the form of Aflex Hose Limited PTFE Flexible Hose and Hose Assemblies are compliant to restrictions on substances listed in Candidate SVHC list updated June 2016 in Annex XVII of REACH.
We declare that our products also comply with ROHS requirements.
SILICONE HOSES
NewAge Industries’ AdvantaPure® high purity products division specializes in ultra-clean products for the pharmaceutical, biopharmaceutical, food, and cosmetic industries. All products are manufactured, stored, and shipped using the cleanest methods possible to ensure unsurpassed product purity for the customer.
Tubing, reinforced hose, and molded products are manufactured, inspected, and packaged in our custom built, Class 7, ISO certified clean rooms. The AdvantaPure production facility is certified by an outside source to meet ISO 9001:2008. We adhere to good manufacturing procedures with special consideration for ventilation and air seals, appropriate clothing and coverings, and quality inspections. Many of our products, after undergoing extensive physical, chemical, and biological testing, meet USP Class VI, FDA, ISO, NSF, European Pharmacopoeia, and 3-A standards.
FITTINGS AND OTHER
*Certification: ISO 9001:2008, CE, Registration of trademark, SGS certificate.
