https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
Normative basis
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025
29.02. 2028
Locations Scope Norm / Revision Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025
29.02. 2028
Avient Colorants USA LLC
17 Foss Rd.
https://www.avient.com/sites/default/files/2022-02/MEVOPUR Bio-based Solutions Application Bulletin_JP.pdf
ISO13485認証取得の4拠点で製造し、グロー
バルで同品質の製品を安定的に供給致します。
規制対応
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•
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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。
https://www.avient.com/sites/default/files/resources/ISO_13485_Certificate.pdf
FACILITY1_LINE4:
FACILITY1_LINE5:
FACILITY1_LINE6:
STANDARD: ISO 13485:2016
MANAGEMENT_TYPE2: The Quality Management System is applicable to:
DATE_LABEL_1TF:
DATE_VALUE_1TF:
DATE_LABEL_2TF:
DATE_VALUE_2TF:
DATE_LABEL_3TF: Certificate No:
DATE_VALUE_3TF: 54139
DATE_LABEL_4TF: Certification Date:
DATE_VALUE_4TF: 04 September 2019
DATE_LABEL_5TF: Effective Date:
DATE_VALUE_5TF: 01 September 2016
DATE_LABEL_6TF: Expiration Date:
DATE_VALUE_6TF: 01 September 2022
DATE_LABEL_7TF: Revision Date:
DATE_VALUE_7TF: 04 September 2019
MARK_3:
MARK_2:
SIGNATURE_NAME: Dominic Townsend, President
SIGNATURE_IMAGE: 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
AUDIT_COMPLIANCE:
MARK_1:
SCOPE_DESCRIPTION: DESIGN, COMPOUND AND SUPPLY OF THERMOPLASTICS FOR THE MEDICAL DEVICE INDUSTRY.
https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB
MANUFACTURER
N E E D L E H U B C O L O R S
• RAL and Pantone® colors available in palette to align with
ISO 6009 color standard
• Opaque and transparent polypropylene selections
available in both masterbatch and ready-to-use precolors
• Raw materials pre-tested to ISO 10993 and USP Class VI
medical device guidelines
• Certified formulations available globally
• Provided RAL and Pantone colors as
required
• Developed custom polypropylene
formulations to meet specific opacities
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the value chain
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Colors
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
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Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Administration, Site management, Manufacture,
Laboratory, Procurement, Maintenance,
infrastructure, Warehouse and Transport
Normative base
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025
Issue 01. 03. 2022
A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
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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/2023-01/45324-Certificate-13JAN2023.pdf
ISO 13485:2016
The Quality Management System is applicable to:
Certificate No: 45324
Certification Date: 24 February 2014
Effective Date: 13 January 2023
Expiration Date: 23 January 2026
Revision Date: 13 January 2023 Dominic Townsend, President
DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE
MEDICAL DEVICE INDUSTRY
This certificate may be found on the ABS QE Website (www.abs-qe.com).
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 Corporation
ISO 13485:2016
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/2024-01/Global Standard Response_Dec 2023.pdf
Some have additional certifications such as
ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and
IATF.
https://www.avient.com/company/policies-and-governance/it-systems-use-policy
9
10
Annex 1 - ISO 13485 certification for Mevopur manufacturing sites North America
& EMEA.
Avient Colorants Sweden AB in Malmoe and Avient Colorants USA LLC in Lewiston, Maine are Medical
Centers of Competence with an external ISO 13485 certification.
https://www.avient.com/sites/default/files/2022-06/Malmoe 308840_en_13485_22.pdf
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 37081 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
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/2021-02/mevopur-needle-one-pager-case-study.pdf
H Y P O D E R M I C N E E D L E
M A N U FAC T U R E R
N E E D L E H U B , C O V E R A N D
S H I E L D
• Compliance to ISO 6009 color coding for single use hypodermic
needle
• Biocompatibility of all component materials
• Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?