https://www.avient.com/news/non-pfas-flame-retardant-formulations-expand-avient-s-compl-t-long-fiber-polyketone-portfolio
These values were determined using Avient’s PCF Calculator, which is third-party certified by TÜV Rheinland and aligns with ISO-14067:2018 standards.
https://www.avient.com/news/pharmapack-2025-feature-polymer-colorants-and-additives-avient-enhance-performance-and-sustainability
The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”
https://www.avient.com/industries/healthcare/medical-devices-equipment/respiratory-care-anesthesiology
Polymer technologies manufactured under controlled conditions and ISO 13485-certified sites to meet strict regulatory requirements
https://www.avient.com/news/avient-expands-launch-new-recycled-tpe-grades-asia-support-greater-use-recycled-materials-automotive-vehicles
In addition, Avient can provide product carbon footprint (PCF) values for these and other products using our PCF calculator, which was developed in accordance with ISO 14067:2018 Standard and third-party certified by TÜV Rhineland.
https://www.avient.com/sites/default/files/2024-06/39913 - Ecert issued 14 Jun 24.pdf
Certificate - IATF 16949 - Avient Corporation - 596306 - 2806569 (2).pdf
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/2020-10/mulch-films-case-study.pdf
Mulch films case study
BIODEGRADABLE &
COMPOSTABLE
M U L C H F I L M S
• Compliance with European Standard EN17033 or OK
Compost
• Black and white color standards available
under different TÜV Austria certifications
(OK Compost and more)
• Full support for end-product certification for
both EN13432 and EN17033
• Formulated with pigments tested and
approved by certified body
OnColor™ Bio-Colorants
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-05/certincorporation-64590-17may2021.pdf
Certificate of Incorporation
AVIENT NEW ZEALAND LIMITED
64590
NZBN: 9429040671338
This is to certify that HOECHST (NEW ZEALAND) LIMITED was incorporated under the Companies Act
1955 on the 3rd day of May 1963
and changed its name to HOECHST NEW ZEALAND LIMITED on the 30th day of January 1974
and was reregistered to become a company under the Companies Act 1993 on the 3rd day of April
1995
and changed its name to CLARIANT (NEW ZEALAND) LIMITED on the 27th day of June 1997
and changed its name to AVIENT NEW ZEALAND LIMITED on the 17th day of May 2021.
Registrar of Companies
17th day of May 2021
Certificate generated 17 May 2021 09:10 AM NZST
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.