https://www.avient.com/news/super-tough-nylon-formulations-added-avient-s-recycled-content-portfolio
Avient PCF values are determined using its PCF Calculator, which is certified by TÜV Rheinland and meets the ISO 14067:2018 standard.
https://www.avient.com/news/avient-and-plastic-bank-reuse-ocean-bound-plastic-luxury-caps-and-closures
¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=0
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
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?