https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?sust[]=1133
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?ind[]=6601
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/sites/default/files/2025-01/ISCC Certificate Luxembourg%2C France.pdf
Version / Date: 1 (no adjustments) / 30.12.2024
Page 1 of 2
ISCC PLUS Certificate
Certificate Number: ISCC-PLUS-Cert-PL214-26100824
Bureau Veritas Polska Sp. z o.o.
Version / Date: 1 (no adjustments) / 30.12.2024
Page 2 of 2
Annex I to the certificate:
Sustainable materials handled by the certified site
(This annex is applicable for all scopes except of Trader, Trader with storage, Warehouse, Logistic centres,
MTBE and ETBE)
This annex is only valid in connection with the certificate:
ISCC-PLUS-Cert-PL214-26100824 issued on 30.12.2024
Input material Output material
Add-ons
(voluntary)1)
Raw
material
category2)
SAI
FSA3)
FEFAC4)
Polypropylene (PP) Plastic Compounds (PP) NO
Bio
Bio-circular
Circular
N/A N/A
Polyethylene (PE) Plastic Compounds (PE) NO
Bio
Bio-circular
Circular
N/A N/A
1) ISCC PLUS add-ons (voluntary application, see www.iscc-system.org for further information):
• 202-04: Food Security Standard • 205-02: Consumables
• 202-07: Low ILUC-risk feedstock • 205-03: Non GMO for food and feed
• 205-01: GHG emission requirements • 205-04: Non GMO for technical markets
2) Bio raw materials complies with the ISCC Principles 1 – 6 for the cultivation and harvesting of sustainable biomass.
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/knowledge-base/article/deep-black-shades-polyester-textiles?rtype[]=1164
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?ind[]=21537
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?sust[]=1139
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
USP Class VI and ISO 10993-4/5 compliant
ASTM ISO Shore A/D
ASTM/ISO %
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
Standard colors for use in needle hubs (ISO 6009)
Global network of ISO 13485 certified manufacturing sites
ISO 6009 color range