https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-ophthalmic-closures-application-bulletin-cn.pdf
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发布的注册药品管理档案(III类)和/或医
疗器械管理档案
食品接触符合FDA/EU*要求
•
•
•
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
变更控制记录的不限于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
标准母粒在PE载体中提供,可根据要求在PP
中提供
可以采用针对应用选择的特定树脂提供预着色
配方
•
•
•
•
•
药物类型 颜色说明 潘通色号参考 埃万特产品代码(PE基)
肾上腺素能激动剂组合 浅绿色 373 C PE6M176349
肾上腺素能激动剂 紫色 2583 C PE4M176057
抗感染药 棕褐色 467 C PE8M176130
非甾体类抗炎药 灰色 冷灰色 4 C PE7M176184
甾体类抗炎药 粉色 197 C PE3M176237
免疫调节剂类抗炎药 橄榄绿 5763 C 按要求提供
β-受体阻滞剂 黄色 黄色 C PE1M176160
β-受体阻滞剂组合 深蓝色 281 C PE5M176272
碳酸酐酶抑制剂 橘黄色 1585 C PE2M176089
细胞毒素 黑色 6 C PL9M176008
缩瞳剂 深绿色 348 C PE6M176267
散瞳剂和睫状肌麻痹剂 红色 1797 C PE3M176236
前列腺素类似物 绿松石 326 C PE5M176273
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。
https://www.avient.com/sites/default/files/2021-01/amendment-to-articles-commercial-registration-avient-corporation.pdf
Brown:
Please be advised that the office of the Secretary of State has reviewed your pre-
clearance request for the Certificate of Amendment for PolyOne Corporation.
If you wish to expedite the amendment certificate
the fees are listed.
NOW, THEREFORE, BE IT RESOLVED, that, effective as of the time and date that
the applicable certificate is accepted for filing by the Ohio Secretary of State (the
“Effective Time”), the name of the Company shall be changed from “PolyOne
Corporation” to “Avient Corporation.”
https://www.avient.com/sites/default/files/2024-06/Avient Melle - 2024.pdf
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
die Einführung und Anwendung eines Managementsystems gemäß
DIN EN ISO 50001:2018
für den Geltungsbereich:
Entwicklung und Produktion von technischen Thermoplasten; an den Standorten
gemäß Anlage.
https://www.avient.com/sites/default/files/2024-04/CCG Application Snapshot_Endoscope.pdf
Surgical instrument oem
S U RG I C A L
I N S T RU M E N T O E M
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-hc-syringe-plunger-spanish.pdf
Versaflex HC - Syringe Plunger - Spanish
FABRICANTE DE
JERINGAS
É M B O L O D E J E R I N G A
D E S E C H A B L E
• Cumplir con las normas USP VI e ISO 10993-4,5
• Esterilización con gamma y EtO
• Rendimiento de sellado a largo plazo
• Bajo coeficiente de fricción (COF)
• Rendimiento uniforme en jeringas de diferentes diámetros
• Ofreció una solución formulada que cumple
con los requerimientos rigurosos de una
aplicación médica
• Mejoró la continuidad del suministro global
• Aumentó la eficiencia del proceso al
sustituir el material termoestable anterior
con un TPE
Versaflex™ HC 2110-57B
REQUERIMIENTOS CLAVE
¿POR QUÉ AVIENT?
https://www.avient.com/sites/default/files/2020-07/versaflex-bvm-resuscitator-bag.pdf
Versaflex - BVM Resuscitator Bag
B A G - VA LV E - M A S K ( B V M )
M A N U FA C T U R E R
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/2021-02/custom-gls-tpe-touriquet-band-case-study-one-pager.pdf
G L O B A L E L A S T I C &
R U B B E R P R O D U C T
M A N U FA C T U R E R
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/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
E U R O P E A N M E D I C A L
D E V I C E M A N U FA C T U R E R
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/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RE S P IRATORY
DE VICE
MANUFACT URE R
C P A P M A C H I N E C O V E R
• Good aesthetics with high COF for grip functionality
• Chemically bondable to FR PC/ABS down to 1mm
• NCS S 9000-N color suitable for UV laser marking to white
• Good scratch and mar resistance
• Good chemical resistance to detergents, alcohols and bleach
• Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017
• Customized formulation to balance mar
resistance, flow, and laser marking
whiteness and clarity
• Collaborated on tooling improvements to
widen processing window and increase
yield rate
• Provided application development and on-
site technical support to manage short
shot, sink marks, burn marks and air trap
Customized VersaflexTM TPEs
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-02/case study snapshot-Ostomy bag-G2705.pdf
PowerPoint Presentation
M E D I C A L D E V I C E
M A N U FA C T U R E R
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?