https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
MSC Certificate Place and date: For the issuing office: Høvik, 23 January 2025 DNV Product Assurance AS Veritasveien 1, 1363 Høvik, Norway Cecilie Gudesen Torp Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ICP-4-5-i5-ISO13485-f1 rev2 ACCREDITED UNIT: DNV Product Assurance AS, Veritasveien 1, 1363 Høvik, Norway - TEL: +47 67 57 99 00. www.dnv.com MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com
https://www.avient.com/services/oncolor-portfolio-ipad-app
https://itunes.apple.com/us/app/polyone-oncolor-portfolio/id594944287?
https://www.avient.com/resource-center/knowledge-base/article/apparent-hardness-vs-thickness-overmold-applications
Table 1 illustrates some common GLS Materials, their supplied hardness, and the relationship between hardness and thickness.
Versaflex™ CL2000X
https://www.avient.com/sites/default/files/2021-02/versaflex-wireless-charger.pdf
WIRELESS CHARGER BRAND W I R E L E S S C H A R G E R • Good surface finish • UV and stain resistance • Abrasion resistance • Bonding to PC • Provided total solution for product with excellent surface results plus on-site technical support to improve customer’s yield • Improved excellent UV and stain resistance performance to meet stringent requirements • Delivered outstanding anti-abrasion and anti-scratch performance Versaflex™ CE 3130-80N TPE KEY REQUIREMENTS WHY AVIENT?
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https://www.avient.com/sites/default/files/2022-03/Versaflex-Footwear insert-Application snapshot_0330.pdf
SOFT TOUCH + COLORABILITY FOOTWEAR ACCESSORY BRAND F O O T W E A R I N S E R T • Low durometer with good processability • Optimal cushioning with high elasticity • Non-tacky feel • Excellent colorability • Customized a formulation to achieve super soft gel performance without a tacky finish • Provided material with sufficient cushioning and elasticity for all-day comfort • Optimized lead time and stable supply with local inventory Versaflex™ Customized TPE KEY REQUIREMENTS WHY AVIENT?
All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versaflex-thermoplastic-elastomers
https://www.avient.com/sites/default/files/2020-12/versaflex-cosmetic-droppers-case-study-brief.pdf
VIROSPACK C O S M E T I C D R O P P E R S • Improved chemical resistance • Hardness 45 – 50 • Natural/transparent color • Food contact compliance • REACH compliance • Provided dedicated customer service resources • Reduced cycle time while maintaining similar mechanical properties • Provided a material with easy molding • Enhanced chemical resistance to oil in extreme conditions Versaflex™ Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versaflex-thermoplastic-elastomers VIRospack
https://www.avient.com/sites/default/files/2023-12/Versaflex TPEs for Gasket of Radial Artery Hemostat_Final.pdf
artery tourniquet ARTERY TOURNIQUET MANUFACTURER G A S K E T O F R A D I A L A R T E R Y H E M O S T A T • Super soft feeling • Increased production efficiency by simple injection process • High transparency • Delivered a series of soft-touch TPEs capable of meeting the desired feel • Formulated solutions to comply with FDA regulation for skin contact • Provided easy molding and assembling by onsite technical and customized durometer Customized Versaflex™ TPEs KEY REQUIREMENTS WHY AVIENT?
All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
https://www.avient.com/sites/default/files/2023-08/Versaflex TPE-Charging Gun Grip-Application Snapshot.pdf
AVIENT SOLUTION LEADING EV MANUFACTURER C H A R G I N G G U N G R I P • Good abrasion resistance • Excellent chemical resistance • Nice surface finish • Good bonding with flame retardant PC/ABS • Provided a rubbery touch feel, chemical resistance (including to ethanediol), and better appearance than the incumbent TPV solution • Eliminated a secondary process through two- shot injection molding with good adhesion to PC, ABS, PC/ABS, and copolyester handles • Offered quick technical support to accelerate the product development KEY REQUIREMENTS CHEMICAL RESISTANCE + BONDING LEARN MORE Versaflex™ TPE Formulation Copyright © 2023, Avient Corporation.
All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versaflex-thermoplastic-elastomers
https://www.avient.com/sites/default/files/2021-03/versaflex-click-and-lock-closure-case-study-one-pager.pdf
HOMEWARE PRODUCTS MANUFACTURER C L I P & L O C K C L O S U R E • Food contact compliance • Good compatibility • Excellent hinging properties • Reduce strain marks • Retain clarity • Provided extensive technical support throughout formulation development • Met exact mechanical properties, provided excellent hinging properties and reduced strain whitening marks • Increased flexibility & lowered temperature flexing properties • Enabled customer to differentiate products & add value for the end consumer Versaflex™ Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
All Rights Reserved. https://www.avient.com/products/thermoplastic-elastomers/versaflex-thermoplastic-elastomers Homeware products manufacturer
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-versaflex-ce-wireless-power-bank.pdf
WIRELESS POWER BANK MANUFACTURER W I R E L E S S P O W E R B A N K • Excellent overmolding to PC/ABS • Good stain resistance and UV resistance • Easy processing • Silky Feel • Developed a customized TPE that exhibited better bonding and UV performance than the competition, and met all specification requirements • Supplied a pre-colored formulation to simplify processing and achieve desired look and feel Customized Versaflex™ CE 3120-65 KEY REQUIREMENTS WHY AVIENT?
AVIENT SOLUTION OVERMOLDING + STAIN RESISTANCE LEARN MORE © 2020, All Right Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 https://www.polyone.com/products/thermoplastic-elastomers/versaflex-thermoplastic-elastomers WIRELESS POWER BANK MANUFACTURER