16824-8#ISO 9001 Certificaat Fiber-Line International B.V.

PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Dynaflex™ G2706 28A USP Class VI, ISO 10993, Food contact EtO Soft translucent grade, grippy feel Dynaflex™ G2711 43A USP Class VI, ISO 10993, Food contact EtO Highly colorable solution, grippy feel, low compression set Versaflex™ CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993, US Food contact EtO Clear boilable grades; ABS, PC bondable Versaflex™ G2705 N 60A USP Class VI, ISO 10993, Food contact EtO/Steam High resilience, low compression set Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear VERSAFLEX™ CL AND DYNAFLEX™ TPEs OVERMOLDING FOR ERGONOMICS • Adds good tactile surface with soft-touch feel • Available in a variety of color effects and textures • Improves grip, cushion, and comfort • Enhances functional performance like sealing properties, vibration damping, oxygen barrier, and scratch and abrasion resistance • Reduces assembly costs, good processability • Offers excellent adhesion to a wide range of substrates Applications: • Glucometers • Medical tools overmolds • Injector pens • Analysis devices VERSALLOY™ HC & VERSAFLEX™ HC TPEs SEALING & RESEALING • Rubbery feel and soft touch • No coring, good puncture, and resealability in static stoppers • Meets low coefficient of friction requirements in dynamic seals • Low extractables • Suitable to overmold onto polyolefins Applications: • Sealing and resealing septum • Seals and sanitary gaskets • Syringe plungers and tips MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versalloy™ HC 9210-45N 45A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9210-55N 55A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9210-70N 70A USP Class VI EtO Good processability, smooth surface aesthetics Versalloy™ HC 9220-43N 43A USP Class VI, ISO 10993-4/5 EtO Extrusion grade, high temperature resistance Versaflex™ HC 2110-35N 34A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Resealing, elevated comp set Versaflex™ HC 2110-57B 57A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Low stiction VERSAFLEX™ CL AND DYNAFLEX™ TPEs HIGH CLARITY GRADES WITHOUT PLASTICIZERS • Water clear grades formulated without phthalate plasticizers • Meets medical regulatory USP Class VI and ISO 10993-4,5 • Food contact and FDA compliant • Autoclave and radiation stable • Low extractable • High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70 Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820 Flexural Strength (MPa) 80 90 104 86 68 68 Flexural Modulus (MPa) 2500 2700 2500 2300 1980 1590 HDT: 0.45, 1.8 (MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0 UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0 UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2 COMPETITIVE MATERIAL COMPARISON ENGINEERED POLYMER FORMULATIONS FOR HEALTHCARE TRILLIANT™ HC THERMOPLASTICS The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges of medical devices and equipment.

ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 45324 Certification Date: 24 February 2014 Effective Date: 13 January 2023 Expiration Date: 23 January 2026 Revision Date: 13 January 2023 Dominic Townsend, President DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE MEDICAL DEVICE INDUSTRY This certificate may be found on the ABS QE Website (www.abs-qe.com). WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations Avient Corporation ISO 13485:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

No. 0962.01) 09/05/2023 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION 80 North West Street Norwalk, OH 44857 Craig Polta Phone: 419 660 4278 MECHANICAL Valid To: 2025年9月30日 Certificate Number: 0962.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following tests on plastics: Test Method(s) Test Name ASTM D256; ISO 180 Notched Izod ISO 179 (1eA) Determination of Charpy Impact ASTM D523 Gloss ASTM D618 (Method A) Conditioning of Test Specimens ASTM D792 (Method A) Specific Gravity ASTM D1238 (Method B) Melt Flow Rate ASTM D3012 Thermal Oxidative Stability ASTM D3641 Injection Molding Test Specimens FMVSS 302 Flammability ASTM E1331; SAE J1545 Spectrophotometric Color Difference SAE J1885 (Rev. Accredited Laboratory A2LA has accredited AVIENT CORPORATION Norwalk, OH for technical competence in the field of Mechanical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).

Certificate - ISO 9001 - Avient Corporation - 337726 - 23521667 (1).pdf

Steel – Static 0.25 0.46 0.18 0.15 0.12 0.19 0.11 0.14 0.13 0.24 0.17 0.17 Impact Notched Izod Impact (23°C, 3.18 mm, Injection Molded) J/m ASTM D256A 41 64(6) 110 107 107 70 80 37 37 75 – 69 Thermal Properties Heat Deflection Temperature ASTM D648 0.45 MPa °C 215(6) – 250 215 216 184 152 151(6) 153(6) 218(6) – – 1.8 MPa °C 65(6) 239(7) 244(6) 210 210 75 94 81.1(6) 88 197(6) – 135(5) Electrical Properties Surface Resistivity ohms/sq ASTM D254 – – – 1.30x1012 1.9x1012 5.2x1012 – – – – – 1.0x109 Dielectric Strength (Short Time) kV/mm – – 8.5 – – – – – – – – – Flammability Flame Rating Class UL 94 HB – – HB HB HB – HB – – – – LubriOne™ Internally Lubricated Formulations NOTES (1) Type I, 5.1mm/min (2) Type I, 21.3 mm/min (3) Type I, 50 mm/min (4) Type I, 5.1mm/min, Break (5) 3.2 mm thick, Unannealed (6) 6.35 mm thick, Unannealed (7) 3.2 mm thick, Annealed PRODUCT DESCRIPTION UNITS TEST METHOD LB6000- 5024 RS HI Natural LB6000- 5021 RS S1 Black LB6000- 5021 RS X2 Black LB6000- 5019 X1 Black LB6700- 5001 RS AF Black NN- 000/01M Black SO REC LB6600- 5030 RS Grey LB3300- 5010 RS Natural LB3300- 5005 RS Natural REC LB3220- 5001 RS C Natural X1 LB8900- 5010 GP Grey LB8900- 5006 RS PE Natural LB8900- 5004 RS PE Natural LB4200- 5022 Black LB4200- 5023 Natural Base Polymer PA 6 PA6/PA66 PA66 PBT PC PKE POM Lubricant UHMWPE1 UHMWPE UHMWPE UHMWPE UHMWPE MoS22 Graphite UHMWPE UHMWPE UHMWPE Graphite UHMWPE UHMWPE MoS2 UHMWPE Filler type GF10 GF30 GF30 GF50 GF50 Unfilled GF33 GF20 MI20 GF10 Unfilled GF20 GF30 Unfilled Unfilled General Properties Specific Gravity g/cm3 ISO 1183 1.18 1.35 1.39 1.55 1.58 1.14 1.44 1.42 1.46 1.23 1.26 1.34 1.43 1.4 1.35 Mechanical Properties Tensile Modulus (23°C) MPa ISO 527-1 4250 9500 9000 15500 16600 3500 10600 6300 3330 4000 1630 5300 9250 2470 2150 Tensile Strength (Yield, 23°C) MPa ISO-527-2 97 150 160 205 200 85 164 102 55 60 60 108 99.1 55 50 Tensile Elongation (Break, 23°C) % ISO-527-2 12 2.5 3 2.7 2.4 3.4 2.0 4.2 8 2.5 46 3.7 1.5 11 11 Flexural Strength (23°C) MPa ISO 178 103 – – 285 265 108 215 127 78 85 38 155 117 73 68 Flexural Modulus (23°C) MPa ISO 178 3250 – – 12400 11100 2690 9000 4700 3000 3100 1380 4600 5450 2210 2070 Impact Charpy Notched Impact Strength (23°C, Injection Molded) kJ/m^2 ISO 179 14 12 10 15 10 3 6 7.7 4.3 12 15 10 7.6 8 5 Charpy Unnotched Impact Strength (23°C, Injection Molded) kJ/m^2 ISO 179 82 55 61 75 60 65 50 47 69 - NB 63 36 NB NB Thermal Properties Deflection Temperature Under Load 1.8 Mpa, Unannealed °C ISO 75-2/A 107 – – 204 – 73 235 – – – 90 210 204 86 80 Cofficient of Friction (CoF) & Wear Rate CoF vs.

Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 28th day of February 2020. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to 2021年12月31日 Revised 2021年9月21日 0514-02s SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 Test Method or Standard: Test Description: 0514-02c

ISO/TS 16949 certifications (7) are site-specific. ISO certificates can be found at www.polyone.com under Quick Links > ISO List. Yes, as part of the ISO 9001 documentation. 8.

Activity: Design and Manufacture of Colorants and Additives for Plastics Page 6 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Compound, Supply, and Prototyping Services of Thermoplastics Activity: Design and Manufacture of Colorants and Additives for Plastics Page 8 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Design and Manufacture of Plastics Compounding Material and Thermoplastic Elastomers Page 10 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

Activity: Design and Manufacture of Colorants and Additives for Plastics Page 6 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Compound, Supply, and Prototyping Services of Thermoplastics Activity: Design and Manufacture of Colorants and Additives for Plastics Page 8 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Design and Manufacture of Plastics Compounding Material and Thermoplastic Elastomers Page 10 of 10 ABS Quality Evaluations Avient Corporation ISO 14001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.