https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB MANUFACTURER N E E D L E H U B C O L O R S • RAL and Pantone® colors available in palette to align with ISO 6009 color standard • Opaque and transparent polypropylene selections available in both masterbatch and ready-to-use precolors • Raw materials pre-tested to ISO 10993 and USP Class VI medical device guidelines • Certified formulations available globally • Provided RAL and Pantone colors as required • Developed custom polypropylene formulations to meet specific opacities • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the value chain • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Colors KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2024-09/31307-Certificate-23AUG2024.pdf
Certificate - ISO 9001 - Avient Corporation - 337726 - 23521672 (1).pdf
https://www.avient.com/sites/default/files/resources/CCG_ISO_9001_2015.pdf
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf
https://www.avient.com/sites/default/files/2025-01/ISO 16949 Tossiat%2C France.pdf
https://www.avient.com/sites/default/files/2023-11/ISO 9001 2015_Hickory NC.pdf
This is to certify that Fiber-Line, LLC 280 Performance Drive SE, Hickory, North Carolina 28602 USA Quality Management System ISO 9001:2015 Manufacture of textile components to cable manufacturers.
Certificate No.: CERT-0116814 Original Certification Date: November 24, 2010 File No.: 1616267 Certification Effective Date: April 1, 2021 Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.
https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
HYPODERMIC NEEDLE MANUFACTURER N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/resources/Polyolefins%2520Product%2520Selection%2520Guide.pdf
This product selection guide provides detailed information to help you select the Maxxam product that’s right for your application. 4 INJECTION MOLDING POLYPROPYLENE Product Code - - - PP5113 B44 F5134T2-4 PP5130 B63 F5134T4-1 Filler Percentage - % - 13 20 30 40 Tensile Strength Yield psi ASTM D638 5000 4800 4600 4500 MPa ISO 527 33 33 32 31 Tensile Elongation Yield % ASTM D638 6 4 3 2 ISO 527 Break % ASTM D638 60 30 15 10 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 300,000 360,000 400,000 460,000 MPa ISO 178 2300 2450 2900 3300 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.65 0.60 0.55 0.50 kJ/m2 ISO 180 3.50 3.3 3.00 2.75 Heat Deflection 66 psi °F ASTM D648 230 240 260 275 °C ISO 75 110 116 127 135 264 psi °F ASTM D648 130 140 150 175 °C ISO 75 54 60 66 79 Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.04 1.15 1.25 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 Product Code - - - PP6113 A77-SM PP6120 B16-2 PP6130 B11 PP6135 B40-UV Filler Percentage - % - 13 20 30 35 Tensile Strength Yield psi ASTM D638 4350 3500 2600 3700 MPa ISO 527 30 24 18 26 Tensile Elongation Yield % ASTM D638 5 4 7 6 ISO 527 Break % ASTM D638 35 70 150 70 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 290,000 280,000 280,000 390,000 MPa ISO 178 2000 1950 1750 2700 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.7 2.7 4.5 0.65 kJ/m2 ISO 180 4.0 14 24 3.5 Heat Deflection 66 psi °F ASTM D648 239 215 225 250 °C ISO 75 115 102 107 123 264 psi °F ASTM D648 140 125 130 150 °C ISO 75 60 52 54 60 Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.18 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9 3.2 mm wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9 Maxxam™ Talc-Filled Copolymer Polypropylene • Scratch & mar resistant • UL approved • FDA certifiable • Natural, black or colors • High flow grades • UV stabilized • UL approved • FDA certifiable • Natural, black or colors • High flow grades • UV stabilized • Recycled content Maxxam™ Talc-Filled Homopolymer Polypropylene Offers a moderate level of impact strength and improved stiffness and heat deflection performance.
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES 51.866.POLYONE www.polyone.com INJECTION MOLDING POLYPROPYLENE Product Code - - - PP5210 A111 PP5220F A1 PP5230F B1 PP5240 A111 Filler Percentage - % - 10 20 30 40 Tensile Strength Yield psi ASTM D638 4600 4300 3900 3500 MPa ISO 527 32 30 27 24 Tensile Elongation Yield % ASTM D638 7.0 6.0 5.5 5.0 ISO 527 Break % ASTM D638 125 115 100 70 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 250,000 285,000 310,000 340,000 MPa ISO 180 1600 1900 2100 2300 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 0.70 0.70 0.70 0.70 kJ/m2 ISO 180 3.85 3.85 3.85 3.85 Heat Deflection 66 psi °F ASTM D648 190 210 225 240 °C ISO 75 88 99 107 116 264 psi °F ASTM D648 120 125 130 133 °C ISO 75 49 52 54 56 Specific Gravity 73°F (23°C) - ASTM D792 0.96 1.04 1.15 1.25 Linear Shrinkage Range 1/8 in wall % - 1.3–1.7 1.1–1.5 0.9–1.3 0.7–1.1 3.2 mm wall % - 1.3–1.7 1.1–1.5 0.9–1.3 0.7–1.1 Product Code - - - PP6210 A11 PP7220 A614 PP6230F A1 PP6240 A44 Filler Percentage - % - 10 20 30 40 Tensile Strength Yield psi ASTM D638 3200 3400 2800 2550 MPa ISO 527 22 24 19 18 Tensile Elongation Yield % ASTM D638 14.0 10.0 8.0 7.0 ISO 527 Break % ASTM D638 >400 >400 >400 200 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 160,000 185,000 250,000 225,000 MPa ISO 178 1100 1300 1750 1550 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 >10.0 >10.0 8 8.0 kJ/m2 ISO 180 55.0 55.0 44.0 14.0 Heat Deflection 66 psi °F ASTM D648 160 170 198 200 °C ISO 75 71 77 92 93 264 psi °F ASTM D648 100 105 108 112 °C ISO 75 38 41 42 44 Specific Gravity 73°F (23°C) - ASTM D792 0.96 1.04 1.15 1.25 ISO 1183 Linear Shrinkage Range 1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0 Maxxam™ Calcium Carbonate Filled Homopolymer Polypropylene Maxxam™ Calcium Carbonate Filled Copolymer Polypropylene Offers improved stiffness over unfilled materials as well as substantial improvement in drop weight impact and notched izod impact.
These materials offer an excellent balance of stiffness, impact resistance and dimensional stability. • FDA certifiable • Natural, black or colors • UV stabilized Product Code - - - PE4125 B1 Reinforcement Type - - - Talc Reinforcement % - % - 25 Specific Gravity 73°F (23°C) - ASTM D792 1.15 ISO 1183 Tensile Strength Yield psi ASTM D638 4050 MPa ISO 527 28 Tensile Elongation Yield % ASTM D638 10 ISO 527 Break % ASTM D638 40 ISO 527 Flexural Modulus 73°F (23°C) psi ASTM D790 270,000 MPa ISO 178 1850 Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 3.5 kJ/m2 ISO 180 20.0 Heat Deflection 66 psi °F ASTM D648 190 °C ISO 75 88 264 psi °F ASTM D648 115 °C ISO 75 46 PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES 12 www.polyone.com Copyright © 2019, PolyOne Corporation.
https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
_2 /Ju n- 20 19 /V er si on 1 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Administration, Site management, Manufacture, Laboratory, Procurement, Maintenance, infrastructure, Warehouse and Transport Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025 Issue 01. 03. 2022 A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2024-08/LATAM CAI Certifications Bulletin _Portuguese_.pdf
ISO 9001:2015 Cert.
No. 65799 ISO 9001:2015 Cert.
No. 65536 ISO 22000:2018 Reg.