Geon(TM) DB5261 Neutral TT Iso Stable

Versaflex™ OM3060 PP包覆成型 硬度 法规 灭菌 特性 28A 环氧乙烷 柔软的半透明材料，粘性好 43A 环氧乙烷 高度可着色的解决方案， 粘性好，不易压缩变形 42A/ 50A 环氧乙烷 透明的耐高温级材料； ABS、PC可粘合 60A 环氧乙烷/蒸汽 弹性高，不易压缩变形 20A-90A 环氧乙烷 用途广泛，无填充 ABS，PC包覆成型 硬度 法规 灭菌 特性 40A USP VI级，ISO 10993 环氧乙烷 半透明 60A USP VI级，ISO 10993 环氧乙烷 透明 VERSAFLEX™ CL与DYNAFLEX™ 包覆成型，符合人体 工程学设计 触感柔软，有利于形成良好的表面 有多种颜色效果和纹理可供选择 提高抓握力、缓冲力和舒适度 提高性能表现，如密封性能、减震、隔氧、 耐刮擦和耐磨性能 降低装配成本，加工性能良好 可牢固包覆于各种基材上 血糖仪 医用工具包覆成型 注射笔 分析仪器 Dynaflex™ G2706 Dynaflex™ G2711 Versaflex™ CL2242 & CL2250 Versaflex™ G2705 N Versaflex™ HC3810 Versaflex™ OM1040 US食品接触 USP VI级，ISO 10993 材料描述 硬度 法规 灭菌 特性 45A USP VI级 55A USP VI级 70A USP VI级 43A 环氧乙烷 34A USP VI级， ISO 10993-4/5 FDA，USP VI级， ISO 10993 57A 挤出级，耐高温 再密封，压缩变形性能提高 摩擦低 Versalloy™ HC 9210-55N Versalloy™ HC 9210-70N Versalloy™ HC 9220-43N Versaflex™ HC 2110-35N Versaflex™ HC 2110-57B FDA，USP VI级， ISO 10993 环氧乙烷 加工性能良好，表面光洁、美观 环氧乙烷 环氧乙烷 加工性能良好，表面光洁、美观 加工性能良好，表面光洁、美观 高压灭菌、环氧乙烷、 高压灭菌、环氧乙烷、 VERSALLOY™ HC与VERSAFLEX™ HC 密封和再密封 柔软的橡胶质感 无抽芯，静态推塞被刺穿后再密封性良好 满足动态密封的低摩擦系数要求 可萃取物含量低 适合在聚烯烃上包覆成型 密封和密封隔膜 密封件和卫生垫圈 注射器推塞和塞头 Versalloy™ HC 9210-45N 材料描述 硬度 法规 灭菌 特性 65A/ 75A/ 84A 54A 67A 高压灭菌器 透明度高，不含增塑剂，无油 工作温度高，可高温灭菌 环氧乙烷、辐射灭菌 Versaflex™ HC MT555 Versaflex™ HC BT218 VERSAFLEX™ CL与DYNAFLEX™ 高透明度级，不含增塑剂 无色透明级，配方不含邻苯二甲酸酯增塑剂 符合医疗法规USP VI级和ISO 10993-4、5的 要求 食品接触用并符合FDA标准 可高压灭菌和辐射灭菌 可萃取物含量低 透明度高（雾度50 4.1, 100 4.5, 100 4, 70 6, 70 拉伸模量（MPa） 2200 2700 2600 2350 1820 1820 挠曲强度（MPa） 80 90 104 86 68 68 挠曲模量（MPa） 2500 2700 2500 2300 1980 1590 HDT：0.45、1.8（MPa） 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94等级，3.0mm 5VA V-0 5VA V-0 HB V-0 UL-94等级，1.5mm V-0 V-0 5VB V-0 HB V-0 UL-94等级，0.75mm V-1 V-2 V-0 无 无 V-2 竞争材料对比 医疗保健特种工程聚合物配方 TRILLIANT™ HC热塑性塑料 Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。

In addition, the formulation meets ISO 15759 requirements for medical infusion equipment and is manufactured in an ISO 13485 facility.

Certificate Avient Corporation Certificate Of Conformance This is to certify that the Quality Management System of: Avient Corporation 33587 Walker Road Avon Lake OH 44012 has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 9001:2015 The Quality Management System is applicable to: Design and manufacture of colour and additive concentrates, thermoplastic resins and specialty compounds Certificate No: 65799 Certification Date: 01 OCT 2020 Effective Date: 25 SEP 2023 Expiration Date 30 SEP 2026 Revision Date: 06 DEC 2024 Dominic Townsend, President Page 1 of 4 ISO 9001:2015 Certificate Of Conformance ANNEX Certificate No.: 65799 Avient Corporation At the below facilities Avient Corporation - Avon Lake, OH Management of QMS, Design and manufacture of colour and additive concentrates, thermoplastic resins and specialty compounds 33587 Walker Road Avon Lake OH 44012 United States Avient (Argentina) SA Administration, Site management, Manufacture, Laboratory (QC and Colormatching), Procurement, Maintenance, Infrastructure, Warehouse and Transport, Sales Av.

Park, Pudong, Shanghai, China, 201203 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: ISO 9001:2015/GB/T 19001-2016 This certificate is valid for the following scope: Design and Manufacture of Masterbatch C ertificate No: 7071-1998-AQ-RGC-RvA P lace and date: Shanghai, 30 March, 2018 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.

Certificate of Registration 9001:2015 MSP 9001:2015–MSP-ANAB-US (2.0) Page 1 of 2 Certificate of Registration of Quality Management System to ISO 9001:2015 The National Standards Authority of Ireland certifies that: Colorant Chromatics Ab Kroklundsvagen 346 AX-22 320 Odkarby Aland Finland has been assessed and deemed to comply with the requirements of the above standard in respect of the scope of operations given below: The Design, Manufacture and Sales of Fluoropolymer Color Concentrates and Compounds Additional sites covered under this multi-site certification are listed on the Annex (File No. 19.2540/C) Approved by: Geraldine LarkinChief Executive Officer Approved by: Lisa Greenleaf Operations Manager Registration Number: 19.2540/C Certification Granted: 1997年5月15日 Effective Date: Oct 20, 2018 Expiry Date: Oct 19, 2021 National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412 9001:2015–MSP-ANAB-US (2.0) Page 2 of 2 Annex to Certificate Number: 19.2540/C Scope of Registration: The Design, Manufacture and Sales of Fluoropolymer Color Concentrates and Compounds Activity Location Central Management Group, Design, Manufacture Colorant Chromatics Kroklundsvagen 346 AX-22 320 Odkarby Aland Finland File No.: 19.2540/C Headquarters, Sales, Distribution Colorant Chromatics Europe B.V.

MATERIAL BRIEF DESCRIPTION FR PC/ABS Flame retardant, chemical resistance, high ESCR FR PC/PET Flame retardant, impact modified, chemical resistant FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance FR Copolyester Flame retardant, chemical resistant, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8920 FR Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance Table 2.

規制対応 評価試験：- ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。

主な特徴 ISO 13485の管理基準化で製造。規制対応 評価試験*: - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材料) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 軽量化 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。

Based on polysulfone resins and tested to ISO 10993, this line of opaque and transparent colorants is specifically formulated to achieve high heat resistance in healthcare applications.  Formulated with raw materials tested to ISO, USP, EP, and ICH Q3D protocols, the portfolio includes standard color ranges to speed up time to market and custom color solutions tailored to customer requirements.