https://www.avient.com/sites/default/files/resources/0514_02%2520PDI%2520ISO17025%2520Chemical_Extension%2520Cert2019.pdf
Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 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). Presented this 30th day of March 2018. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to 2019年12月31日 Revised 2019年10月8日 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf
https://www.avient.com/sites/default/files/2023-10/31307-Certificate-20SEP2023.pdf
Purchasing, Customer Service, Logistics, Quality, Design and Sampling; Corporate HQ, Management of QMS Activity: Manufacture of Engineered Thermoplastics Page 3 of 7 ABS Quality Evaluations Avient Corporation ISO 9001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Manufacture of Colorants for Plastics Activity: Manufacture of thermoplastic compounds Page 4 of 7 ABS Quality Evaluations Avient Corporation ISO 9001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Manufacturing, Shipping and Receiving Activity: Compound and supply of thermoplastics for the medical device industry Page 5 of 7 ABS Quality Evaluations Avient Corporation ISO 9001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2021-04/colormatrix-optica-specialty-toners-for-pc-product-bulletin.pdf
MARKETS AND APPLICATIONS ColorMatrix Optica is formulated for PC resins used in the production of: • Automotive interiors • Appliance housings • Consumer goods • Food packaging • Finished materials such as PC sheet • Electrical & Electronics REGULATORY • No heavy metals or restricted ingredients • In-house chemical testing and verification system compliant with ISO ISO/IEC 17025:2005 • Dedicated product stewardship team globally and locally
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS • Medical devices • Drug delivery devices • Labware KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China has been assessed and certified as meeting the requirements of 麟 ISO 13485:2016 EN ISO 13485:2016 ’骥鑫馨瓤) For the foiowing actratEes Design and manufacture of medical grade thermoplastic elastomers for non-active medical devices and active medical devices 遴;舞蒸;撇蒸 (non-implantable) :护、::于 b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2024-12/ISO9001 2015 Certificate for Shenzhen Plant%282024-2027%29.pdf
No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong, China 518104 has been found to conform to the Quality Management System standard: GB/T 19001-2016 / ISO 9001:2015 This certificate is valid for the following scope: Development and Manufacture of Masterbatch, Pigment Concentration, Plastisol; Manufacture of Plastic Compounding Material http://www.dnv.com/assurance 证书制作地点及日期: 证书认可签发机构: 上海, 2024年10月 10日 DNV - Business Assurance 中国上海市长宁区虹桥路1591号9号楼A座 邮编: 200336 电话: +86 21 32799000 朱海明 管理代表 未履行认证协议中规定条款会导致此证书失效,获证组织必须定期接受监督审核并经审核合格此证书方继续有效。获得认可的单位: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance 本证书信息可在国家认证认可监督管理委员会官方网站(WWW.CNCA.GOV.CN) 上查询 管理体系认证证书 证书号码: 3033-2006-AQ-RGC-RvA 首次签发日期: 2018年11月 07日 有效期限: 2024年11月 08日 – 2027年11月 07日 兹证明 普立万聚合体(深圳)有限公司 中国广东省深圳市宝安区沙井镇蚝乡路启航工业园1号 518104 统一社会信用代码:9144030076498189X0 质量管理体系符合 : GB/T 19001-2016 / ISO 9001:2015标准 此证书对下列范围有效: 色母粒,色浆,增塑溶胶的开发和制造;塑料改性材料的制造 http://www.dnv.com/assurance WWW.CNCA.GOV.CN)上查询
https://www.avient.com/sites/default/files/2022-05/DOC 1879.pdf
Is there an Environmental Management System (EMS or/and ISO 14001 certifications) in place? Varies by Site; refer to ISO Cert https://www.avient.com/company/policies-and- governance/global-iso-certificate-library How often are 3rd party audits conducted? IATF and ISO 13485 managed within ETQ Reliance.
https://www.avient.com/sites/default/files/2024-07/31307-Certificate-11JUL2024.pdf
Certificate - ISO 9001 - Avient Corporation - Avon Lake, OH - 337726 - 23521667 (3).pdf
https://www.avient.com/sites/default/files/2021-12/PREPERM _ Edgetek Low-loss Dielectric Thermoplastics Technical Bulletin.pdf
KEY PROPERTIES AND PERFORMANCE FR GRADES H GRADES PEEK GRADES LCP GRADES FLEX GRADES PROPERTIES CONDITION ISO UNIT PPE400FR PPE700FR PPE950FR PPE1200FR H1500HF H2300HF PEEK700 PEEK900 PEEK1000 PEEK1200 LCP650 LCP800 LCP950 FLX400 FLX700 FLX1100 Dielectric Constant (Dk) 2.4 GHz 4.0 7.0 9.5 12.0 15.0 23.0 7.0 9.0 10.0 12.0 6.5 8.0 9.5 4.0 7.0 11.0 Loss Tangent (Df) 2.4 GHz 0.0030 0.0039 0.0042 0.0045 0.0010 0.0037 0.0024 0.0025 0.0024 0.0027 0.0043 0.0045 0.0047 0.0010 0.0009 0.0012 Density 1183 g/cm3 1.44 1.97 2.20 2.50 2.60 3.40 1.94 2.20 2.30 2.40 2.00 2.15 2.30 1.52 1.93 2.50 Melt Flow Index (MFI) 5 kg, 300 °C (unless noted) 1113 g/10 min 17 12 13 5 5 8 15 @ 380 °C 13 @ 380 °C 10 @ 380 °C 6 - - - 11 @ 230 °C 2 @ 230 °C 0.3 @ 230 °C Tensile Strength at Break 23 °C/73 °F 527 MPa 47 52 44 45 23 40 64 62 65 67 75 80 75 11 17 25 Flexural Modulus 23 °C/73 °F 178 MPa 3100 4500 - 9300 2100 5000 6200 7600 9200 11000 8000 8500 8500 1400 1600 2900 Unnotched Izod 23 °C/73 °F 180 kJ/m2 NB 42 20 9 17 10 28 25 18 15 31 20 12 NB NB NB -20 °C/-4 °F 180 kJ/m2 - - - - 17 10 - - - - - - - - - Notched Izod 23 °C/73 °F 180 kJ/m2 14 6 4 3 5 4 6 4 4 4 10 6 4 59 23 13 -20 °C/-4 °F 180 kJ/m2 - - - - 5 4 - - - - - - - - - - STANDARD GRADES RADOME GRADES PROPERTIES CONDITION ISO UNIT PPE260 PPE300 PPE320 PPE350 PPE400 PPE440 PPE500 PPE650 PPE800 PPE950 PPE1200 RS260 RB260 RS265FR Dielectric Constant (Dk) 2.4 GHz 2.6 3.0 3.2 3.5 4.0 4.4 5.0 6.5 8.0 9.5 12.0 2.6 2.6 2.7 Loss Tangent (Df) 2.4 GHz 0.0009 0.0009 0.0010 0.0009 0.0009 0.0009 0.0009 0.0009 0.0009 0.0009 0.0010 0.0009 0.0012 0.0032 Density 1183 g/cm3 1.07 1.18 1.21 1.27 1.43 1.50 1.62 1.86 2.10 2.20 2.40 1.06 1.08 1.09 Melt Flow Index (MFI) 5 kg, 300 °C 1113 g/10 min 15 15 16 14 14 14 15 11 10 4 2 21 16 25 Tensile Strength at Break 23 °C/73 °F 527 MPa 40 45 47 50 50 48 45 43 37 37 36 50 42 52 Flexural Modulus 23 °C/73 °F 178 MPa 2700 2400 2000 2600 2800 2700 2600 2600 2300 2600 2600 2200 2200 2600 Unnotched Izod 23 °C/73 °F 180 kJ/m2 NB NB NB NB NB NB NB NB 50 28 24 NB NB NB -20 °C/-4 °F 180 kJ/m2 NB NB NB NB NB NB NB 50 47 27 25 NB NB NB Notched Izod 23 °C/73 °F 180 kJ/m2 8 55 69 35 22 20 15 9 8 5 4 19 14 11 -20 °C/-4 °F 180 kJ/m2 8 15 20 14 12 10 9 8 8 5 4 10 12 10 PREPERM™ SERIES PROPERTIES CONDITION ISO UNIT 8027 8025 8037 8019 8028 8026 8044 8029 8041 8045 8048 8036 8056 8031 Dielectric Constant (Dk) 1 GHz, 23 °C 3.0 3.1 3.4 3.6 3.8 4.4 4.8 5.3 5.4 5.9 6.0 7.0 7.3 9.0 Loss Tangent (Df) 1 GHz, 23 °C 0.0012 0.0012 0.0008 0.0010 0.0010 0.0010 0.0004 0.0008 0.0006 0.0002 0.0006 0.0007 0.0002 0.0007 Density 1183 g/cm3 1.25 1.26 1.35 1.39 1.45 1.59 1.72 1.75 1.79 1.89 1.88 2.06 2.086 2.25 Melt Flow Index (MFI) 5 kg, 300 °C 1113 g/10 min 16 19 10 11 15 13 10 10 15 15 19 10 18 4.7 Tensile Strength at Break 23 °C/73 °F 527 MPa 59 54 54 62 59 54 52 58 52 45 49 45 37 38 Flexural Modulus 23 °C/73 °F 178 MPa 2780 2560 2850 3060 3350 3700 3157 4300 4320 3137 4150 3370 2560 4200 Notched Izod 23 °C/73 °F 180 kJ/m2 15.3 14 14.8 14 12.6 10.4 9.9 8.6 7.4 7.9 6.6 7.1 6.2 6.8 EDGETEK™ 7600 SERIES Copyright © 2021, Avient Corporation.