https://www.avient.com/sites/default/files/2024-04/CCG Application Snapshot_Endoscope.pdf
Surgical instrument oem
SURGICAL
INSTRUMENT OEM
E N D O S C O P E C O M P O N E N T S
• Functional differentiation
• ISO 10993 compliance
• Excellent resistance to steam sterilization
• Excellent chemical resistance
• Delivered a variety of bright, distinguishing color
choices for functional differentiation
• Minimized color deviation
• Provided a biocompatible solution
• Offered low MOQ with flexible supply
Transcend Premier PPSU Healthcare Pre-
colored Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag
BAG-VALVE-MASK (BVM)
MANUFACTURER
R E S U S C I T A T O R B A G
• Compatible gamma sterilization process
• Achieve desired elastomeric properties
• PVC-free formulation
• FDA, ISO 10993, USP VI compliant
• Repeatable injection molding process
• Complemented customer expertise with
technical support in material selection, part &
tool design, and process development
• Customized TPE offered customer an
alternative to vinyl without sacrificing
performance
• Improved process efficiency and overall
system costs through injection molding method
Customized Versaflex™ TPE
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English
SYRINGE
MANUFACTURER
D I S P O S A B L E S Y R I N G E
P L U N G E R
• USP VI and ISO 10993-4,5 compliant
• Sterilize by gamma & EtO
• Long-term sealing performance
• Low coefficient of friction (COF)
• Consistent performance across barrel sizes
• Provided a formulated solution that met
rigorous medical application requirements
• Improved global supply continuity
• Increased process efficiency by replacing
previous thermoset material with TPE
Versaflex™ HC 2110-57B
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
EUROPEAN MEDICAL
DEVICE MANUFACTURER
F A C E M A S K V E N T I L A T I O N
V A L V E
• ISO 9001 and USP VI compliant
• Compatible with overmolding onto PP
• Translucent and highly colorable
• Soft touch
• Provided valuable regulatory support and
documentation, enabling faster internal trials and
material qualification for this customer
• Worked together with customer to select the best
material from a broad portfolio of medical TPE
grades
• Trusted as a polymer supplier for multiple
healthcare applications
Dynaflex™ G2711 Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
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/sites/default/files/2022-01/Dynaflex-Disposable syringe tip cap-Application snapshot.pdf
SYRINGE
MANUFACTURING
D I S P O S A B L E S Y R I N G E T I P
C A P
• Excellent sealing and resealing performance
• No DEHP or natural rubber latex added during processing
• Can be sterilized by EtO
• Compliance with ISO 10993-4&5, USP Class VI
Dynaflex™ Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-10/reSound BIO TPE -Underwire-case study snapshot.pdf
FAMOUS
UNDERWEAR
BRAND
U N D E R W I R E
• Formulated a 40% bio-derived material to
help meet customer’s sustainable goals with
good rigidity and supporting strength
• Improved comfort and softness compared to
a normal steel underwire design
• Passed ISO 105-X18 textile test with good
chemical resistance, durability, and wash
fastness
Customized reSound™ BIO TPE
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-02/custom-gls-tpe-touriquet-band-case-study-one-pager.pdf
GLOBAL ELASTIC &
RUBBER PRODUCT
MANUFACTURER
T O U R N I Q U E T B A N D
• Hardness 45, shore A
• Thickness 0.5mm and Tensile set
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Plan%2520Summary.pdf
Contacts
Public Contact
First Name: * Brian
Last Name: * Greer
Position: * EHS Manager
Telephone: * 5192150535
Ext
Fax
Email: * brian.greer@polyone.com
Person responsible for the Toxic Substance Reduction Plan preparation
First Name: * Darryl
Last Name: * Chartrand
Position: * Senior Air Quality Technologist
Telephone: * 4164999000
Ext 73642
Fax 4164994687
Email: * darryl.chartrand@ch2m.com
Employees
Employees
Number of Fulltime Employees: *
16
Copy of Certifications of Plan
Copy of Certifications of Plan
Upload Document
A copy of the certification statement(s) from the Highest Ranking Employee and the Licensed Planner(s), for the Toxic Substance Reduction
Plan for which the Plan Summary is being submitted are required.
Please upload a single document containing all certifications.
Do not upload any certification statements that are dated after December 31.
https://www.avient.com/sites/default/files/2022-06/MEVOPUR Bio-based Solutions Application Bulletin_CN %281%29.pdf
主要特性
可用于聚乙烯、聚丙烯、ABS、聚碳酸酯和苯
乙烯
树脂载体的生物含量从70%到100%不等,具
体取决于聚合物⸺按照ASTM D6866标准计
算
由四家通过ISO 13485认证的工厂生产,稳定
的供应链覆盖全球,品质始终如一
变更控制记录的级别高于CAS编号级别,降低
变更风险
可以像加工化石基聚合物般在普通注塑机和挤
出设备上进行产品加工的嵌入式解决方案
可以以即用型预着色或添加剂配方的形式提供
法规支持
原材料根据以下标准检测:
- ISO 10993-1
- 美国药典和(包括VI类)
- 欧洲药典,各论3.1.3/3.1.5(聚烯烃包装材
料)
- 美国药典(聚乙烯)
- 杂质元素符合ICH Q3D要求
注册药品管理档案(III类)和/或器械主文件
食品接触声明符合美国FDA和EU规范
适用医疗保健使用限制—见下文。
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途:
(a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或
(b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者
(c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。