ISO PURPLE TPU UV FL YELLOW 1 Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)

主要特性 生产符合高于CAS编号级别的变更控制原则 （与MEVOPUR母粒类似），降低变更风险 不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 • • • 注册药品主文件（III型） 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试： - ISO 10993-1 - USP第、章，包括VI级别，符合眼 科和鼻腔用药物要求 - 欧洲药典3.1.3/3.1.5（聚烯烃） - 美国药典（聚乙烯） - ICH Q3D 杂质元素 - USP和USP，透光率 • • • 载体材料 耐光性 热稳定性 产品代码颜料含量/类型 HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 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。 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。

Global ISO Certificate Library

Global ISO Certificate Library

Avient follows the ISO 14067:2018 standard to calculate PCF values and utilizes global formulation expertise, green manufacturing processes, and sourcing & logistics competence to achieve such low or negative values.  

PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067

Surgical instrument oem S U RG I C A L I N S T RU M E N T O E M E N D O S C O P E C O M P O N E N T S • Functional differentiation • ISO 10993 compliance • Excellent resistance to steam sterilization • Excellent chemical resistance • Delivered a variety of bright, distinguishing color choices for functional differentiation • Minimized color deviation • Provided a biocompatible solution • Offered low MOQ with flexible supply Transcend Premier PPSU Healthcare Pre- colored Solutions KEY REQUIREMENTS WHY AVIENT? All Rights Reserved https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants Slide 1: Surgical instrument oem

Zwolseweg 1, 2994 LB, Barendrecht, Netherlands. Park, Pudong, Shanghai, China, 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch

Kalisabi No. 1, Kec. Cibodas Kecamatan Cibodas, Tangerang 15138 Indonesia 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. 46391 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Made sqs.ch F.

Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 462307-2021-AQ-RGC-RvA Initial certification date: 23 June 2021 Valid: 24 June 2024 – 23 June 2027 This is to certify that the management system of Avient China Company Limited No. 188, Quanzhou Road, Zhongxin Suchu High-Tech Industrial Development Park, Chuzhou, Anhui, China 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: Design and Manufacture of Color Concentrates, Filling Concentrates and Additive Concentrates http://www.dnv.com/assurance