主要特性 在四个通过ISO 13485认证的医疗生产线生 产，拥有全球统一的配方，提供一致性和供 应链保障 变更控制记录的不限于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 不同的琥珀色色调，可根据要求定制—偏红色 或偏黄色，和/或颜色浅或深 适用于液体形式 法规支持 经过预测试的原材料： - ISO 10993-1和USP第、 部分（VI级） - 欧洲药典，，美国药典， 元素分析符合ICH Q3D - USP 溶液性状、颜色标准 FDA发布的注册药品主文件（III类） 食品接触符合FDA/EU*要求 符合YBB00102002-2015 (口服液体药用聚酯 瓶）标准 1.844.4AVIENT www.avient.com 适用医疗保健使用限制—见下文。

1 (3) Pending matter(s) The register indicates pending matter(s) regarding a change to the registered information at the time this certificate was created. 2 (3) Registration number: 516411-5031 Business name: Avient S.à r.l., Sweden Filial Address: Drottninggatan 56 411 07 GÖTEBORG County and municipality: Västra Götaland, Göteborg Note: MANAGING DIRECTOR 630516 Palm, Christoph, Gruss Strooss 35, L-9991 WEISWAMPACH, LUXEMBURG AUDITORS 556053-5873 Ernst & Young Aktiebolag, Box 7850, 103 99 STOCKHOLM Represented by: 850807-5135 PRINCIPALLY RESPONSIBLE AUDITOR 850807-5135 Edman, Mikael Thomas Gunnar, c/o Ernst & Young AB, 401 82 GÖTEBORG SIGNATORY POWER Signatory power alone by Palm, Christoph FINANCIAL YEAR Registered financial year: 0101 - 1231 DATE OF REGISTRATION OF CURRENT AND PREVIOUS BUSINESS NAMES 2021-11-29 Avient S.à r.l., Sweden Filial 2018-08-28 PolyOne S.à.r.l., Sweden Filial INFORMATION ABOUT THE FOREIGN COMPANY B226205 Avient S.á.r.l. 19, Route de Bastogne L-9638 Pommerloch LUXEMBURG Registered office of the foreign company: Pommerloch Name of the register in which the foreign company is registered: 3 (3) RCS, Registre de Commerce, Luxembourg Business Register LUXEMBURG Foreign company's financial year: 0101 - 1231 The above information is an extract from the Trade and Industry Register Bolagsverket, the Swedish Companies Registration Office.

PROFILE/SHEET EXTRUDER R A I L S A N D K I C K P L A T E S • Convert existing PVC profile and sheet rails and kick plates to polyolefin resin to meet Class A fire safety (ASTM E84) • Provide a system that meets healthy building certifications and approvals • Utilize a more sustainable flame retardant technology, removing brominated or halogenated flame retardants from the environment • Achieve non-compromising performance in aesthetics, impact, dimensional stability, CLTE, and E84 testing • Provided broad flame retardant platform, backed by extensive application and industry expertise, to meet global flammability standards • Has largest UL94 recognized Prospector membership with HB, V-0, V-1, V-2 and 5VA/5VB ratings, and broad glow wire performance products • Included in-house UL certified labs and manufacturing locations to perform UL94 material sampling and testing • Supported application development to meet fire safety standards, address current or emerging healthy building codes, smart home requirements, and LEED credits • Offered custom formulations in small lot quantities Cesa™ Flam Non-Halogen Flame Retardants KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION CERTIFICATIONS + QUALITY LEARN MORECopyright © 2022, Avient Corporation.

MAIA+ N° rapport :223-2023-000066-FR 10898066 0.5 jour Date Début / Fin :04/11/2022 /04/11/2022 PolyOne France - site de Saint Ouen l'Aumône 1 /11 ATTESTATION DE RECONNAISSANCE Attribué à PolyOne France - site de Saint Ouen l'Aumône 14 avenue de l'Eguillette / ZA du Vert Galant 95310 - SAINT OUEN L'AUMONE - FRANCE Bureau Veritas Certification certifie que les prestations de l’entreprise susmentionnée ont été évaluées et jugées conformes aux caractéristiques énoncées dans le décret en vigueur à la date d’édition du présent certificat : Décret n°2021-461 du 16 avril 2021 relatif à la prévention des pertes de granulés de plastiques industriels dans l’environnement Sous réserve du respect des caractéristiques vérifiées, cette attestation est valable jusqu’au : 16/02/2026 Date originale : 17/02/2023 Attestation n°: 223-2023-000066-FR Date : 17/02/2023 Affaire n°: 10898066 Laurent CROGUENNEC - Président Adresse de l’organisme certificateur : Bureau Veritas Certification France Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense Des informations supplémentaires concernant le périmètre de cette attestation ainsi que l'applicabilité des exigences du décret peuvent être obtenues en consultant l'organisme.

ECert - 2023-11-22T151036.517.pdf Page 1 of 10 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof. This certificate may be found on the ABS QE Website (www.abs-qe.com). For certificates issued in the People's Republic of China information may also be verified on the CNCA website (www.cnca.gov.cn).

ISO 845

They are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety. 

Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding

Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance

This information sheet shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities. This information sheet shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities.