https://www.avient.com/news/avient-showcase-newest-additions-its-healthcare-portfolio-mdm-west-2025
Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Plan%2520Summary.pdf
lang=En&n=3C401D5C-1 http://www.ec.gc.ca/default.asp?
lang=En&n=BD3CE17D-1 http://www.ec.gc.ca/default.asp?
n=29E6BF9F-1&lang=en http://www.ec.gc.ca/default.asp?
https://www.avient.com/sites/default/files/2025-01/ISO 16949 Tossiat%2C France.pdf
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.
https://www.avient.com/sites/default/files/2024-02/US_OH_North Baltimore_ ISO_IEC 17025.pdf
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).
https://www.avient.com/news/avient-unveils-high-temperature-vibrant-colorants-healthcare-mdm-west-2022
They are tested to ISO 10993 standards, and can be customized with the addition of functional additives to enhance product performance.
Media contact
Scott Collins
scollins@collins-marcom.com
+1 216.382.8840
https://www.avient.com/news/avient-launches-two-new-sustainable-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2021
MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants
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Tested to ISO 10993
https://www.avient.com/sites/default/files/2024-08/Avient 2023 Sustainability Report_6.pdf
Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and Responsible Care®.
This methodology was developed in accordance with ISO 14067:2018 for product carbon footprint and is aligned with ISO 14040/140440 for life cycle analysis.
locale=en https://www.carbon-minds.com/ https://www.certipedia.com/quality_marks/0000084994?
https://www.avient.com/sites/default/files/2024-08/Avient-2023-Sustainability-Report_5.pdf
Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and Responsible Care®.
This methodology was developed in accordance with ISO 14067:2018 for product carbon footprint and is aligned with ISO 14040/140440 for life cycle analysis.
locale=en https://www.carbon-minds.com/ https://www.certipedia.com/quality_marks/0000084994?
https://www.avient.com/sites/default/files/2022-07/Mevopur Standard Colors Product Bulletin-CN.pdf
Mevopur Standard Colors Product Bulletin-CN3.26-1 MEVOPUR™ 着色剂 医疗应用的标准颜色 关键特性 • • • • • 监管支持 • • 预先测试的原材料库,包括: - ISO 10993 - USP , (class VI) - USP - ICHQ3D 可提取金属 - EuPh 向FDA提交的DMF / MAF文档适用于所有标 准颜色 医疗应用 • • • 医疗设备,例如导管,手术和牙科器械或药 物输送设备 药物包装,包括药瓶或瓶子 血液分析诊断或体外诊断(IVD) 产品公告 & 色卡 MEVOPUR 着色剂解决方案组合专为当今日益复 杂的医疗保健应用而设计。
™ 在三个通过ISO 13485认证的医疗产线生产 全球统一的配方,提供全球一致性和供应链 保障 提供文件化的变更控制 原料指纹图谱和常规批次测试 多种标准颜色缩短产品开发时间 产品组合里符合标准的颜色用于: - 注射针头ISO 6009 - 眼科容器盖(美国眼科学院 / AAO - American Academy of Ophthalmology) 颜色 潘通色 参照 PE 基料 PP 基料 透明PP 基料 PEBA 基料 PC 基料 ABS 基料* — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 颜色可能与显示的实际颜色有所不同。