https://www.avient.com/sites/default/files/2022-10/Tossiat-IATF 16949-2016 POLYONE FRANCE SAS.pdf
1/2
IATF 16949 - First EditionIATF 16949 - First Edition
(The official document is in English.
https://www.avient.com/sites/default/files/2023-07/Versaflex HC _ Versaflex HC BIO - BT Series Product Overview.pdf
KEY CHARACTERISTICS
• Meets critical need for thermal weldability
and kink resistance
• Minimizes extractables during processing
• Provides excellent tensile strength
• Complies with USP VI and ISO 10993-4, -5, -11
certifications
• Suitable for gamma and autoclave
sterilization methods
• Bio-based grade option formulated with nearly
40% Gen 1 biomass content
PRODUCT OVERVIEW
1.844.4AVIENT
www.avient.com
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2021-12/certificate-of-registration-avient-s.a-r.l.-sweden-filial-nov-29-2021.pdf
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
1 (3)
Pending matter(s)
The register indicates pending matter(s) regarding a change to
the registered information at the time this certificate was created.
https://www.avient.com/sites/default/files/2023-06/AVIENT_TPEs and LSR eBook.pdf
One caveat: Typical TPE shrinkage is around 2% while that of substrate materials
is closer to 1%.
When looking to incorporate sustainable content into your TPE, the raw
material cost may be more expensive than traditional materials for three
reasons 1) supply chain maturity, 2) high demand, low supply, 3) location
of source and supplier.
http://www.art.canaco.org
https://www.avient.com/sites/default/files/2020-11/gls-acqua-plose-case-study.pdf
1http://store.elsevier.com/Handbook-of-Polymer-Applications-in-Medicine-
and-Medical-Devices/isbn-9780323221696/
Tear Resistance
PERFORMANCE COMPARISON
In Handbook of Polymer Applications in Medicine and Medical
Devices,1 Laurence W.
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-and-additives-for-ivd-devices-application-bulletin-cn.pdf
主要特性
在三个通过ISO 13485认证的医疗生产线生
产全球统一的配方,提供全球一致性和供应
链保障
变更控制记录不限于CAS编号级别,降低变
更风险
•
•
不含动物源性物质和邻苯二甲酸盐
可用作各种聚合物的母粒或即用型配方
为方便起见,可在一个产品中实现功能性和颜
色的组合
•
•
•
法规支持
经过预测试的原材料:
- ISO 10993-1
- USP 第、章(VI类)
- USP (指南),6.2.3 可萃取元素;
USP
- ICHQ3D/USP 2 可萃取金属
- 欧洲药典 3.1 聚烯烃(如适用)
FDA发布的注册药品主文件(III类)和/或医疗
器械主文件
为符合(新)法规(如IVDR)的批准或过渡提
供文档支持
•
•
•
适用医疗保健使用限制—见下文。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2020-08/wilflex-ghosting-tips-techniques.pdf
In order for ghosting to occur, these 5 factors must
co-exist.
1.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for Medical Devices Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Available as additive concentrates, ready-to-use
additive formulations or ready-to-use additive/
colorant formulations for different polymers
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*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request; exceptions may occur
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-03/Trilliant HC Electrically Conductive Formulations for Pipette Tips Application Bulletin.pdf
APPLICATION BULLETIN
1 Typical properties: these are not to be construed as specifications
HOW TRILLIANT™ HC FORMULATIONS HELP TO SOLVE THE MOST DIFFICULT
PERFORMANCE AND PROCESS CHALLENGES
Trilliant HC conductive thermoplastics can be customized to meet your unique challenges.
https://www.avient.com/sites/default/files/2020-10/trilliant-xr-product-bulletin.pdf
PRODUCT BULLETIN
PROPERTY TEST METHOD TYPICAL VALUE (ENGLISH)
TYPICAL VALUE
(SI)
Specific Gravity ASTM D-792 11.0 11.0
Tensile Modulus1 ASTM D-638 1.20E+6 psi 8270 MPa
Tensile Strength1 (Yield) ASTM D-638 3,950 psi 27.2 MPa
Flexural Modulus ASTM D-790 800,000 psi 5520 MPa
Flexural Strength ASTM D-790 7,000 psi 48.3 MPa
Notched Izod Impact2 ASTM D-256A 2.1 ft•lb/in 110 J/m
Deflection Temperature Under Load
66 psi (0.45 MPa), Unannealed,
0.250 in (6.35mm)
ASTM D-648 280°F 138°C
Deflection Temperature Under Load
264 psi (1.8 MPa), Unannealed,
0.250 in (6.35mm)
ASTM D-648 190°F 87.8°C
TECHNICAL PROPERTIES
1 Type I, 0.20 in/min (5.1 mm/min)
2 73°F (23°C), 0.125 in (3.18 mm), Injection molded
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2021-06/colormatrix-oxygen-scavengers-brochure.pdf
PRODUCT RANGE HIGHLIGHTS
Amosorb™ 4020E
• Non-nylon based oxygen scavenging
technology for PET
• Helps to prolong the shelf life of many
products in major markets
Amosorb™ 100
• Non-nylon based oxygen scavenging
technology for PET
• Developed to meet the needs of the
North American market
• Featuring a special additivation package
to allow for pre-consumer regrind
Amosorb™ 4020G
• Lower haze levels and lower impact on PET
recycle stream
• Non-nylon based active oxygen scavenger
• PET and rPET compatible
• Can be used with mono-layer and multi-layer
applications
Amosorb™ 4020R
• Consistent performance with all levels
of rPET (25%, 50% and 100%)
• Improved haze and color when in
combination with rPET
• Flexibility on choice of rPET grade
• Non-nylon based product
Amosorb™ SolO2 -1 (non-carbonated/
carbonated) and SolO2 -2 (carbonated)
• Nylon based oxygen scavenging
technologies for PET
• Active barrier effect to prevent O
2
ingress
• Passive barrier effect to prevent gas ingress
and digress from the packaging
(i.e.