https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
C
er
ti
fi
ed
M
anagement System
s
by
Switzerland
Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative basis mentioned.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 45484 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/2023-10/308659_en_46154.pdf
C
er
ti
fi
ed
M
anagement System
s
by
Switzerland
Certificate
The SQS herewith attests that the organisation named below has a management system that meets
the requirements of the normative basis mentioned.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 46154 Validity 12.01.2022 – 11.01.2025
Issue 12.01.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
F.
https://www.avient.com/sites/default/files/2024-01/308701_en_46090.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
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Certificate
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
Page 1 of 1
Validity 20. 01. 2024 – 19. 01. 2027
Issue 20. 01. 2024
A.Grisard, President SQS F.
https://www.avient.com/news/specialty-polymer-solutions-avient-improved-durability-and-sustainability-healthcare-products-pharmapack-2023
All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.
All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.
https://www.avient.com/resources/safety-data-sheets?page=4731
Geon(TM) DB5323 Neutral TT Imp-Iso No-Stab
Geon(TM) DB5324 Neutral TT Imp-Iso Stab
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=6425
MAUVE DOOR, ISO FIX COVER
HAZEL DOOR, ISO FIX COVER V2
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/company/sustainability/planet
Global ISO Certificate Library
https://www.avient.com/company/sustainability/performance
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/candidate-privacy-notice
Global ISO Certificate Library
https://www.avient.com/news/‘future-proof’-pharma-packaging-avient-launches-new-regulatory-compliant-mevopur-amber-masterbatches
Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients.
They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with:
• ISO 10993-1 and USP parts , (including class VI)
• European Pharmacopoeia, monograph 3.1.15
• USP and
• elemental analysis, as per ICH Q3D