MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield

Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Any translations of this document shall be used for reference only.) and the applicable customer specific requirements Revision:1 For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France None Bureau Veritas Certification Certificate N°: FR072877- IATF IATF Certificate N°: 442787 Date Of Expiration: 01-February-2025 Date Of Certification: 02-February-2022 PRODUCT(S) DELIVERED colour with additive concentrates for thermoplastic resins and speciality compounds obtained by mixing and extrusion PERMITTED EXCLUSION(S) SCOPE Design and manufacturing Bureau Veritas Certification certify that the Quality Management System of the above organisation has been audited and found to be in accordance with the requirements of Route de la Vavrette, 01250, TOSSIAT France PolyOne France Tossiat Awarded to Certificate of Approval https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L REMOTE SUPPORT FUNCTION(S) (The official document is in English. Revision:1 For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France Bureau Veritas Certification Certificate N°: FR072877- IATF IATF Certificate N°: 442787 Date Of Expiration: 01-February-2025 Date Of Certification: 02-February-2022 Route de la Vavrette, 01250, TOSSIAT France PolyOne France Tossiat Awarded to Appendix to the Certificate of Approval Name Address Scope AVIENT LUXEMBOURG ROUTE DE BASTOGNE, 19, 9836, POMMERLOCH Luxembourg Logistic, Supplier Management, Purchasing PolyOne Europe Logistics 7 rue Blériot, 4460, GRACE HOLLOGNE Belgium Warehousing Polyone Europe ul.

质量管理体系认证认证 Certificate No.：04621E14082R0S We hereby certify that the organization: Fiber-Line Asia Pacific (Changzhou) Co., Ltd. Unified social credit code: 91320412MA1NMF5W4P is in conformity with Environmental Management System Standard: GB/T24001-2016 / ISO14001:2015 The certificate is valid to the following product(s)/service: Textile (Yarn), Glass Products (Yarn) Coating Processing and Related Management Activities Registration Address/ Physical Address: R&D Workshop 5, No. 8, Lanxiang Road, West Taihu Science and Technology Industrial Park, Changzhou City, Jiangsu Province, P.

For and on behalf of BSI: Carlos Pitanga, Chief Operating Officer Assurance – Americas Certification Date: 2018-07-11 Latest Issue: 2018-07-11 Expiry Date: 2021-07-10 BSI Certificate Number: 85585 IATF Number: 0315491 Page: 1 of 2 This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. An electronic certificate can be authenticated online.

Certificate of Amendment Loi canadienne sur les sociétés par actionsCanada Business Corporations Act Certificat de modification Avient Colorants Canada Inc. 942266-8 Corporate name / Dénomination sociale Corporation number / Numéro de société Raymond Edwards Date of amendment (YYYY-MM-DD) Date de modification (AAAA-MM-JJ) Director / Directeur 2021-01-15 I HEREBY CERTIFY that the articles of the above-named corporation are amended under section 178 of the Canada Business Corporations Act as set out in the attached articles of amendment.

Medical textile manufacturer LEARN MORE MEDICAL TEXTILE MANUFACTURER S U R G I C A L D R A P E S & G O W N S • Pre-tested for ISO 10993 biocompatibility standard • Available in standard blue or other customized colors • Compatible with ETO sterilization • Suitable for use in non-woven SMS spunbond layer • Offered standard blue and custom colors such as green • Pre-tested raw materials for biocompatibility ISO10993 standard • Manufactured under ISO 13485 certified medical sites with change control in place MevopurTM Healthcare Colorants and Formulations KEY REQUIREMENTS WHY AVIENT?

主要特性 在三个通过ISO 13485认证的医疗生产线生 产全球统一的配方，提供全球一致性和供应 链保障 变更控制记录不限于CAS编号级别，降低变 更风险 • • 不含动物源性物质和邻苯二甲酸盐 可用作各种聚合物的母粒或即用型配方 为方便起见，可在一个产品中实现功能性和颜 色的组合 • • • 法规支持 经过预测试的原材料： - ISO 10993-1 - USP 第、章（VI类） - USP （指南），6.2.3 可萃取元素； USP - ICHQ3D/USP 2 可萃取金属 - 欧洲药典 3.1 聚烯烃（如适用） FDA发布的注册药品主文件（III类）和/或医疗 器械主文件 为符合（新）法规（如IVDR）的批准或过渡提 供文档支持 • • • 适用医疗保健使用限制—见下文。 埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途： (a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. 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 10 ABS Quality Evaluations Avient Corporation RC14001®: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 RC14001®:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.