https://www.avient.com/company/sustainability/planet/environmental-stewardship
ISO 14001 certifications follow intensive environmental audits of organizations, conducted by third-party ISO representatives.
At present, multiple Avient facilities hold ISO 14001 Certification.
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2022-09/Additives and Colorants for Stadium and Arena Seats Application Bulletin.pdf
AFNOR M 2 in France, DIN 4102 B 2–B 1 in
Germany, UNI 8457–9174 C 1 in Italy, BKZ 5.2
in Switzerland, BS 5852.1990 CRIB 3–5 in UK)**
• Standard portfolio available for PP injection
molded applications
APPLICATION BULLETIN
* Laboratory weathering testing may not be determinative of all conditions of use;
the end user must determine suitability of a product for its intended use
** Contact us for more information on regulatory compliance
Copyright © 2022, Avient Corporation.
COLOR RAL REFERENCE COLOR RAL REFERENCE
1015 Brown/12 6026 Green/14
1034 Yellow/14 6032 Green/20
1018 Yellow/19 7004 Grey/21
1003 Yellow/20 8025 Brown/14
3020 Red/15 9022 Pearl Grey/1
5005 Blue/35 9010 White/5
5000 Blue/36
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
Get Help Now
+1-866-737-2066
ASTM ISO Shore A/D
ASTM/ISO %
https://www.avient.com/resources/safety-data-sheets?page=852
BLUE 4715 PE 1 RR
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
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/news/medtec-china-2024-avient-announces-healthcare-tpu-manufacturing-expansion
Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.
Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications.
PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.
https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
Normative base
ISO 22000:2018 Food Safety Management Systems - Requirements
for any organization in the food chain
Reg. no. 46389
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 20. 12. 2023
A.Grisard, President SQS F.
https://www.avient.com/news/avient-highlight-bio-based-polymer-solutions-pharmapack-2024
Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.
Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally.
Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Get Help Now
+1-866-737-2066
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission
ISO 6009 color range
https://www.avient.com/resources/safety-data-sheets?page=2221
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)