https://www.avient.com/sites/default/files/2025-03/65537-Certificate-05MAR2025.pdf
Rev1
This certificate’s validity is subject to the organization maintaining their system in accordance with ABS Quality Evaluations, Inc. 1701 City Plaza Dr Spring, TX
77389 USA requirements for management system certification.
Rev1
This certificate’s validity is subject to the organization maintaining their system in accordance with ABS Quality Evaluations, Inc. 1701 City Plaza Dr Spring, TX
77389 USA requirements for management system certification.
Rev1
This certificate’s validity is subject to the organization maintaining their system in accordance with ABS Quality Evaluations, Inc. 1701 City Plaza Dr Spring, TX
77389 USA requirements for management system certification.
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
https://www.avient.com/sites/default/files/2021-12/Chemically Resistant Materials Whitepaper.pdf
Schematic representation of creep mechanism; chain alignment and void formation in response to applied stress.
3© 2021 Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
There are several key factors which can influence
the timeline to ESC failure:
1.
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.
- -
8© 2021 Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
Table 3B.
https://www.avient.com/content/name-change-details
Avient Colorants USA LLC
Avient Colorants USA LLC
https://www.avient.com/news/extreme-conditions-are-no-match-new-outdoor-sign-material
The company is headquartered in Kingsport, Tennessee, USA, and employs approximately 15,000 people around the world.
https://www.avient.com/resources/safety-data-sheets?page=1594
9279-H-61 CERT.
https://www.avient.com/resources/safety-data-sheets?page=2984
CX-6180-B CERT.
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.