https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing risk of change
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP
biological evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-02/Sustainability ESG Disclosures_Silicon Dioxide.pdf
CATEGORY DETAIL
EC Number 231-545-4
CAS Number 7631-86-9
Chemical Name Silicon Dioxide (SiO2)
Structural Formula
CHEMICAL IDENTITY
Si
O O
HEALTH EFFECTS
HUMAN HEALTH SAFETY ASSESSMENT
Consumer No human health hazard has been identified relating to this substance.
https://www.avient.com/sites/default/files/2021-06/inscripcion-registro-santiago-cambio-razon-social-performance-masterbatches618874v1.pdf
Santiago, 3 Junio 2021
C
ód
ig
o
de
V
er
ifi
ca
ci
ón
: 0
12
-2
10
6-
03
09
-1
14
2
012-2106-0309-1142
Documento incorpora Firma
Electronica Avanzada
Código de Verificación: cec_1c0abd-0 pagina 2 de 2
EDUARDO JAVIER DIEZ MORELLO
2021-06-03T10:28:54-0600
Santiago
Firma Electrónica Notario
2021-06-04T10:37:47-0400
https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
MEDICAL DEVICE
MANUFACTURER
O S T O M Y B A G S E A L S
• Comply with ISO 10993 and FDA Class II medical device
regulations
• Offer Good sealing performance
• Provide technical supports for processing
recommendations
• Deliver a high compression set materials to improve
comfort
• Provided a medical-grade TPE to help the
customer meet necessary regulatory
specifications and gain market share
• Provided technical support during design
and the manufacturing process for EVA
bonding
• Delivered soft-touch feel and excellent
sealing performance
Versaflex HC Thermoplastic Elastomers -
G2705 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/news/polyone-expands-automotive-engineered-polymer-portfolio-electriplast-conductive-long-fiber-technology
Applications for ElectriPlast include: Shielding Wire, Power Electronics, Connectors, and Cables; Shielding, Conduction, Batteries, Heated Elements, Sensors, Antennas, Medical Devices, Consumer Electronics and Acoustics, Fuses, Capacitors, Bi-Polar Plates, Resistors, Bus bars, ESD, Static Dissipation and Terminals.
https://www.avient.com/resources/safety-data-sheets?page=4237
Geon(TM) V4788-10 Hot Dip for Battery Cable
https://www.avient.com/resources/safety-data-sheets?page=943
DB2800 BLACK BATTERY TERMINAL
https://www.avient.com/resources/safety-data-sheets?page=2331
DB2800 RED BATTERY TERMINAL
https://www.avient.com/knowledge-base/article/exploring-world-fluoropolymers?ind[]=21509
Fluoropolymers are also enabling new technologies: they are used as films that function as a lightweight alternative to glass in solar panels, and to make safe batteries for electric vehicles.