No. 0514.01) 12/11/2023 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION – ANALYTICAL SOLUTIONS 33587 Walker Road Avon Lake, OH 44012 Stephanie Mims Phone: 440 930 3499 MECHANICAL Valid To: September 30, 2025 Certificate Number: 0514.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following rubber and plastics tests: Test Description Test Method or Standard Brittleness Temperature (Impact) ASTM D746; ISO 812 Charpy Impact ISO 179-1 Color Determination by Spectrophotometer ASTM D2244, E1331; ISO 7724 Conditioning of Plastics for Testing ASTM D618; ISO 291 Deflection Temperature Under Flexural Load ASTM D648; ISO 75-1, -2 Durometer Hardness (Shore A and D) ASTM D2240; ISO 7619-1 Flexural Properties ASTM D790; ISO 178 Flow Rate (Extrusion Plastometer) ASTM D1238 (Procedures A and B); ISO 1133 Impact Resistance (Izod) ASTM D256; ISO 180 Instrumented Impact ASTM D3763; ISO 6603-2 Specific Gravity/Density ASTM D792 (Method A); ISO 1183-1 Specular Gloss ASTM D523; ISO 2813 Tackiness of Interior Materials BO 061-01 Tear Resistance ASTM D624, D1004; ISO 34 Tensile Properties ASTM D412 (Method A), D638, D882; ISO 37, 527-1, -2, -3, -4, -5 Xenon-Arc Exposure Testing ASTM D2565, G155; SAE J1885 (Withdrawn January 2008), J1960 (Withdrawn January 2008), J2412, J2527; BO-116-01 For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation. 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). Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.01 Valid to September 30, 2025 0514-01 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 Test Method or Standard Test Description 0514-01c

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

The timetable for testing, certification and enforcement as outlined on the CPSC web site (see link in adjacent column), generally requires compliance in advance of testing and certification. PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body. Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They can be customized to meet specific regulatory demands such as USP Class VI, FDA CFR, and ISO 10993.   Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.