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。
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/2024-08/OnColor REC Door Panel Case Study Snapshot.pdf
AUTOMOTIVE OEM
I N T E R I O R D O O R P A N E L
• Available for multiple resins and approved OEM colors
• Maintain performance characteristics of traditional raw
materials that use conventional carbon black
• Pass REACH and RoHS requirements
• Retain color consistency and stability
• Provide a Product Carbon Footprint (PCF) calculation that
aligns with ISO 14067:2018
• Provided recycled content formulations that
met all design and engineering goals while
achieving sustainability targets
• Provided effective alternative to materials
using virgin carbon black
• Achieved color stability under xenon arc and
TUV methodology
• Supplied necessary PCF calculation
certified by TÜV Rheinland and aligning with
ISO 14067 requirements
OnColor™ REC Polymer Colorants
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2024-08/Textile _ Fabric OnColor REC Snapshot.pdf
FIBER
MANUFACTURER
T E X T I L E S & F A B R I C S
• Provide a Product Carbon Footprint (PCF) calculation to align
with ISO 14067:2018 and to help in meeting sustainability
goals
• Procure feedstock from renewable resources
• Maintain comparative performance to conventional carbon
black
• Achieve color stability under xenon arc and TUV testing
• Offer solutions for rPET, PP, PE, PBT, and PA6 where a
desire for environmentally responsible products exists
• Offered sustainable platform approach supported by
extensive fiber expertise
• Helped meet sustainability targets while attaining all
design and engineering goals
• Supplied necessary PCF calculation certified by
TÜV Rheinland and aligning with ISO 14067
requirements
• Provided effective alternative to virgin carbon black
• Achieved reductions in CO2e emissions vs.
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/2023-10/Value Added Services Brochure.pdf
A RANGE OF WORLD-CLASS SERVICES
COLOR TECHNOLOGY
Custom matching, saturated colors, and special
effects to fill market niches, eliminate secondary
operations, and strengthen your brand
PCR COLOR PREDICTION SERVICE
Digital prediction tool illustrating color possibilities
and limitations of post-consumer recycled (PCR)
content to simplify decision making and shorten
time to launch
PRODUCT CARBON FOOTPRINT (PCF)
CALCULATOR
Methodology that evaluates the carbon footprint of
Avient solutions, contributing a data point to your
overall carbon footprint and supporting credible
reporting
AVIENT DESIGN
A highly specialized group of industrial designers
and project engineers that provides advanced
design and detailed analysis to foster higher levels
of innovation
TESTING AND VALIDATION
Fully accredited and in-house testing capabilities
to generate data for insight into material behavior,
environmental effects, and more
REGULATORY SUPPORT
Dedicated product stewardship team assisting
with new product approvals to reduce regulatory
overhead and minimize risk
COLOR AND ADDITIVE DESIGN SERVICES
Trend and color insights along with product
development assistance from concept through
commercialization to optimize design and gain
speed to market
RESEARCH AND DEVELOPMENT
Long-term strategic solution development that
addresses complex and unmet product innovation
needs
APPLICATION DEVELOPMENT TECHNICAL
SUPPORT
Technical experts specifically trained to work
directly with your team to solve definitive
application challenges with new or existing
approaches
FIELD TECHNICAL SERVICE
Onsite support for tool design, startup, and
production optimization to gain manufacturing
efficiencies and help resolve technical issues
Common compliance categories
where we can assist:
• UL
• USP Class VI
• ISO 10993
• ISO 1345
• REACH
• RoHS
• FDA
• EU 10/2011
• China GB
• MERCOSUR
• USP
• ISP
• CPSIA
• Prop 65
ColorWorks™ Design &
Technology Centers
Our global ColorWorks centers are
focused on design, technology, and
innovation for plastics.
https://www.avient.com/sites/default/files/2023-10/Stat-Tech TPE Static Dissipative _ Electrically Conductive Thermoplastic Elastomers Product Overview_A4.pdf
These include:
• Industrial – Conveyor belts (food production
and pharmaceutical industries) and controls
( joy sticks, machinery handles and knobs,
corrugated bellows, tool grips)
• Electrical and electronic devices – Seals and
gaskets, radars and sensors
• ADAS components – Camera systems,
navigation systems, vehicle control systems,
infotainment systems
PRODUCT OVERVIEW
STAT-TECH SOLUTIONS
KEY TECHNICAL PROPERTIES
Material
Description
Base
Resin Color
Hardness
Range
Surface
Resistivity (Ω)
Key
Characteristics
ST0100-5003 ESD FD White
VN8904 GP0F025721
TPU White 85 ShA 108 to 109
High elongation, static conductive,
FDA compliance
ST0100-5006 ESD X2 Natural TPU Natural 85 ShA 107 to 109 High elongation, static conductive
ST0200-5001 ESD Natural X1 TPE Natural 40 ShD 107 to 109
High elongation, permanent anti-static,
static conductive
SST0200-5004 ESD Black TPE Black 40 ShA 103 to 105
Electrically conductive,
static dissipative, lower hardness
ST0200-5002 EC ES Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation
ST0200-5009 EC Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation
Property Unit
Standard
Test
Methods
ST0100-5003
ESD FD White
VN8904
GP0F02571
ST0100-
5006
ESD X2
Natural
ST0200-
5001 ESD
Natural X1
ST0200-
5004 ESD
Black
ST0200-
5002 EC
ES Black
ST0200-
5009 EC
Black
Base Resin TPU TPU TPE TPE TPE TPE
Physical Properties
Hardness Shore ISO 48-4 85A 85A 50D 40A 60 A 60A
Density ISO 1183 1.19 1.15 1 1.01 0.965 1.21
Mechanical Properties
Tensile Strength (Break) Mpa DIN 53404 10 15 15 4 5.7 2.5
Elongation, Break % DIN 53504 600 650 500 300 400 250
Electrical Properties
Surface Resistivity Ω IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102
Volume Resistivity Ω.cm IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102
Color White Natural Natural Black Black Black
Copyright © 2023, Avient Corporation.
https://www.avient.com/news/where-sustainability-matters-avient-highlight-its-latest-solutions-support-circular-economy-chinaplas-2023
They are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/continuous-glucose-monitors-cgm
Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance
https://www.avient.com/products/advanced-composites/continuous-fiber-composite-panels/hammerhead-marine-composite-panels
ISO 845
https://www.avient.com/industries/healthcare/catheter-materials-medical-tubing/catheters
Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding