https://www.avient.com/sites/default/files/308837_en_46388.pdf
Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46388 Page 1 of 1 Validity 25. 02. 2024 – 24. 02. 2027 Issue 25. 02. 2024 A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English SYRINGE MANUFACTURER D I S P O S A B L E S Y R I N G E P L U N G E R • USP VI and ISO 10993-4,5 compliant • Sterilize by gamma & EtO • Long-term sealing performance • Low coefficient of friction (COF) • Consistent performance across barrel sizes • Provided a formulated solution that met rigorous medical application requirements • Improved global supply continuity • Increased process efficiency by replacing previous thermoset material with TPE Versaflex™ HC 2110-57B KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag BAG-VALVE-MASK (BVM) MANUFACTURER R E S U S C I T A T O R B A G • Compatible gamma sterilization process • Achieve desired elastomeric properties • PVC-free formulation • FDA, ISO 10993, USP VI compliant • Repeatable injection molding process • Complemented customer expertise with technical support in material selection, part & tool design, and process development • Customized TPE offered customer an alternative to vinyl without sacrificing performance • Improved process efficiency and overall system costs through injection molding method Customized Versaflex™ TPE KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2022-01/Dynaflex-Disposable syringe tip cap-Application snapshot.pdf
SYRINGE MANUFACTURING D I S P O S A B L E S Y R I N G E T I P C A P • Excellent sealing and resealing performance • No DEHP or natural rubber latex added during processing • Can be sterilized by EtO • Compliance with ISO 10993-4&5, USP Class VI Dynaflex™ Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2023-10/reSound BIO TPE -Underwire-case study snapshot.pdf
FAMOUS UNDERWEAR BRAND U N D E R W I R E • Formulated a 40% bio-derived material to help meet customer’s sustainable goals with good rigidity and supporting strength • Improved comfort and softness compared to a normal steel underwire design • Passed ISO 105-X18 textile test with good chemical resistance, durability, and wash fastness Customized reSound™ BIO TPE WHY AVIENT?
https://www.avient.com/sites/default/files/resources/Ahrensburg_ISO50001.pdf
Avient Colorants Germany GmbH Kornkamp 50 22926 Ahrensburg Germany Scope Production of Color- and Additives Concentrates, Compounds and Foaming Agents Normative base ISO 50001:2018 Energy Management System Reg. no. 46090 Validity 20. 01. 2021 – 19. 01. 2024 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.
https://www.avient.com/sites/default/files/2024-02/Sant Andreu_ISO22000.pdf
Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Madesqs.ch F.
https://www.avient.com/sites/default/files/2025-06/NEUSoft-Catheter-case study snapshot.pdf
MEDICAL DEVICE MANUFACTURER G U I D I N G C A T H E T E R • Ultra-soft hardness of about Shore 50A • Excellent extrusion performance, achieving a thickness of about 0.1 mm • Smooth surface • Certification for biocompatibility • Delivered an ultra-soft TPU that has good elasticity, abrasion, and tear resistance • Complied with ISO 10993 biocompatible properties • Offered onsite service to support rapid extrusion performance for the customer NEUSoft Thermoplastic Polyurethanes KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
EUROPEAN MEDICAL DEVICE MANUFACTURER F A C E M A S K V E N T I L A T I O N V A L V E • ISO 9001 and USP VI compliant • Compatible with overmolding onto PP • Translucent and highly colorable • Soft touch • Provided valuable regulatory support and documentation, enabling faster internal trials and material qualification for this customer • Worked together with customer to select the best material from a broad portfolio of medical TPE grades • Trusted as a polymer supplier for multiple healthcare applications Dynaflex™ G2711 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-ophthalmic-closures-application-bulletin-cn.pdf
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发布的注册药品管理档案(III类)和/或医 疗器械管理档案 食品接触符合FDA/EU*要求 • • • 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 标准母粒在PE载体中提供,可根据要求在PP 中提供 可以采用针对应用选择的特定树脂提供预着色 配方 • • • • • 药物类型 颜色说明 潘通色号参考 埃万特产品代码 (PE基) 肾上腺素能激动剂组合 浅绿色 373 C PE6M176349 肾上腺素能激动剂 紫色 2583 C PE4M176057 抗感染药 棕褐色 467 C PE8M176130 非甾体类抗炎药 灰色 冷灰色 4 C PE7M176184 甾体类抗炎药 粉色 197 C PE3M176237 免疫调节剂类抗炎药 橄榄绿 5763 C 按要求提供 β-受体阻滞剂 黄色 黄色 C PE1M176160 β-受体阻滞剂组合 深蓝色 281 C PE5M176272 碳酸酐酶抑制剂 橘黄色 1585 C PE2M176089 细胞毒素 黑色 6 C PL9M176008 缩瞳剂 深绿色 348 C PE6M176267 散瞳剂和睫状肌麻痹剂 红色 1797 C PE3M176236 前列腺素类似物 绿松石 326 C PE5M176273 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。