Global ISO Certificate Library

Global ISO Certificate Library

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

MEVOPUR Bio-based Solutions Application Bulletin_CN5.30-1 生物基聚合物解决方案 可持续发展关注的焦点 生物聚合物 应用公告 用于医疗器械和药品包装的MEVOPUR™ 越来越多的医疗器械和药品包装制造商面临着将 可持续性融入其产品设计的挑战。 主要特性 可用于聚乙烯、聚丙烯、ABS、聚碳酸酯和苯 乙烯 树脂载体的生物含量从70%到100%不等，具 体取决于聚合物⸺按照ASTM D6866标准计 算 由四家通过ISO 13485认证的工厂生产，稳定 的供应链覆盖全球，品质始终如一 变更控制记录的级别高于CAS编号级别，降低 变更风险 可以像加工化石基聚合物般在普通注塑机和挤 出设备上进行产品加工的嵌入式解决方案 可以以即用型预着色或添加剂配方的形式提供 • • • • • • 法规支持 原材料根据以下标准检测： - ISO 10993-1 - 美国药典和（包括VI类） - 欧洲药典，各论3.1.3/3.1.5（聚烯烃包装材 料） - 美国药典（聚乙烯） - 杂质元素符合ICH Q3D要求 注册药品管理档案（III类）和/或器械主文件 食品接触声明符合美国FDA和EU规范 • • • 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。

MEVOPUR Colors for Ophthalmic Closures Application Bulletin_CN8.18-1 * 可根据要求提供FDA/EU合规信息 应用公告 用于眼科药物容器盖的 着色剂MEVOPUR™ 用于眼部（眼科）用药物容器盖的MEVOPUR标 准母粒系列产品符合美国眼科学会（AAO）的颜 色标准。 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。 在不限制本声明的一般性的情况下，不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用： (1) 接触人体组织或体液长达30天或更长时间； (2)“整形”（整容或重建）手术； (3) 生殖植入物或任何节育器械；或者 (4) 用于支持或维持人类生命的永久性（超过30天）植入式医疗器械中的任何关键组件。

KEY CHARACTERISTICS • Formulated with 25–100% recycled resin from PIR & PCR sources • Reduces waste and supports the circular economy • Achieves equivalent performance to standard polyolefin formulations • Can be recycled at end of life • Provides good stiffness, durability, impact resistance and UV stability • Enables customized performance characteristics depending on application need MARKETS AND APPLICATIONS Maxxam REC Polyolefins are suitable for use across many industries and applications where traditional polyolefin materials are used, including: • Transportation - HVAC systems, engine guards, battery housings, flame retardant applications • Industrial - Structural parts, furniture • Consumer - Household appliances, personal care items, packaging, office supplies, food contact applications • Electrical and Electronic – Housings, buttons, junction boxes SUSTAINABILITY BENEFITS • Formulated with 25–100% recycled resin from PIR and/or PCR sources • Reduces waste and supports the circular economy • Reduces carbon footprint • Can be recycled at end of life PRODUCT BULLETIN CHARACTERISTICS UNITS Maxxam REC RS5200-5029 C BLACK X2 Maxxam REC MX5200-5036 HS I BLACK Maxxam REC MX5200-5037 RS HS I BLACK Maxxam REC MX5200-5038 RS HS I BLACK Maxxam REC MX5200-5039 RS HS I BLACK Filler/ Reinforcement – Unfilled Unfilled 20% Mineral 40% Mineral 30% Glass Fiber Recycled Content – 95% PCR 97% PIR 75% PIR 55% PIR 65% PIR Density (ISO 1183) g/ccm 0.93 0.95 1.09 1.28 1.15 Tensile Modulus (ISO 527-1) MPa 1250 950 1500 2150 4250 Tensile Stress (ISO 527-2) MPa 25 175 10 15 50 Tensile Strain Break (ISO 527-2) % >20 >80 >30 17 4.5 Charpy Notched (ISO 179) kJ/m 3 8 5 4 11 TECHNICAL PERFORMANCE CHARACTERISTICS UNITS Maxxam REC RS5200-5026 RS NHFR BLACK 70 Maxxam REC FR H8 V2 BLACK RG 70 Maxxam REC L6 GF/30 H BLACK T RG 70 Maxxam REC MX5200-5027 RS HS BLACK RG Maxxam REC MX5200-5028 RS HS BLACK RG Maxxam REC C10 H-UV AS EP RG BLACK 70 Filler/ Reinforcement – 30% Glass Fiber Unfilled 30% Glass Fiber 30% Glass Fiber 40% Talcum Unfilled Recycled Content – 37% PIR 90% PIR 55% PIR 35% PIR 50% PIR 25% PIR Density (ISO 1183) g/ccm 1.42 0.950 1.13 1.15 1.23 1.03 Tensile Modulus (ISO 527-1) MPa 8250 1300 6100 6400 – 700 Tensile Stress (ISO 527-2) MPa 71.0 30.0 70.0 70.0 28.0 15.0 Notched Izod (ISO 180) kJ/m – 4.0 10 5.8 2.7 No Break Flame Rating @ 1.6mm thickness (UL 94) – V-0 V-2 HB HB HB HB TECHNICAL PERFORMANCE Copyright © 2023, Avient Corporation.

Date Of Certification: 11 December 2024 Date Of Expiration: 10 December 2027 IATF Certificate N°: 0558656 Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1 For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France (The official document is in English. Any translations of this document shall be used for reference only.) 1/2 Certificate of Approval AWARDED TO PolyOne France Tossiat Route de la vavrette, 01250, Tossiat - France IATF USI: LWZS4P 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 IATF 16949 - FIRST EDITION and the applicable customer specific requirements SCOPE Design and manufacturing PERMITTED EXCLUSION(S) None PRODUCT(S) DELIVERED colour with additive concentrates for thermoplastic resins and speciality compounds obtained by mixing and extrusion https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX Date Of Certification: 11 December 2024 Date Of Expiration: 10 December 2027 IATF Certificate N°: 0558656 Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1 For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France (The official document is in English.

Some have additional certifications such as ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and IATF. Record Retention  Production records are stored for a minimum of 1 year.  ERP records are kept for a minimum of 5 years. https://www.avient.com/company/policies-and-governance/it-systems-use-policy 9 10 Annex 1 - ISO 13485 certification for Mevopur manufacturing sites North America & EMEA.

No. 0562.01) Revised 05/31/2022 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION 733 East Water Street North Baltimore, OH 45872 Claire Holman Phone: (419) 257-1327 MECHANICAL Valid To: October 31, 2023 Certificate Number: 0562.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following automotive plastics tests: Test Method: Test Name: ASTM D412 Tensile ASTM D523 Specular Gloss ASTM D618 (A) Conditioning of Plastics ASTM D624 (Die C) Tear Strength ASTM D638 Tensile Properties ASTM D792 (A) Density and Specific Gravity by Displacement ASTM D1004 Initial Tear Resistance ASTM D1203 (A) Volatile Loss ASTM D1895 (A) Apparent Density, Bulk Factor, Pourability ASTM D1921 Particle Size (Sieve Analysis) ASTM D2240 Durometer Hardness (Shore A and D) ASTM E1331 Color by Spectrophotometry Using Hemispherical Geometry FMVSS 571.302 Flammability FORD BN-102-01 (A) Low Temperature Flexibility FORD BO-131-03 Interior Odor ISO 3795 Determination of Burning Behavior of Interior Materials SAE J323 (A) Cold Cracking (Mandrel Bend) SAE J1351 Hot Odor for Insulation Materials SAE J1545 Instrumental Color Difference Measurement SAE J1756 Fogging Characteristics of Interior Automotive Materials (Photometric Only) DOC-058151 Angle of Repose 1 Laboratory Developed Method For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation. Accredited Laboratory A2LA has accredited AVIENT CORPORATION North Baltimore, 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).

Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes." Global ISO Certificate Library