Also available are OnColor HC Plus Colorants, certified to meet or exceed USP Class VI and ISO 10993 bio-compatibility requirements. KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.

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。

Certificate of Amendment Loi canadienne sur les sociétés par actionsCanada Business Corporations Act Certificat de modification Avient Colorants Canada Inc. 942266-8 Corporate name / Dénomination sociale Corporation number / Numéro de société Raymond Edwards Date of amendment (YYYY-MM-DD) Date de modification (AAAA-MM-JJ) Director / Directeur 2021-01-15 I HEREBY CERTIFY that the articles of the above-named corporation are amended under section 178 of the Canada Business Corporations Act as set out in the attached articles of amendment.

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

ECert.pdf Page 1 of 2 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof. Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. ABS Quality Evaluations This is to certify that the Quality Management System of: PolyOne Corporation PolyOne 1260 Carden Farm Drive Clinton, TN 37716 IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 38223 Effective Date: 03 July 2018 Expiration Date: 02 July 2021 Issue Date: 03 July 2018 IATF No: 0313794 Alex Weisselberg, President DESIGN AND COMPOUNDING OF THERMOPLASTIC PRODUCTS (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Toluca 2000 Toluca, Estado de México 50233 México IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 63431 Effective Date: 25 February 2022 Expiration Date: 24 February 2025 Revision Date: 25 February 2022 IATF No: 0444538 Dominic Townsend, President DESIGN AND MANUFACTURE OF COLOR CONCENTRATES (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations Avient de México, S.A. de C.V. IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

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。

Geon(TM) DB5261 Neutral TT Iso Stable Certificate of Analysis (COA) - labeled as "Material"

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