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。
功能 目标应用 血液采集 试剂容器/
试剂盒
移液器/
器具 设备/配件
即用型配方避免对分析测试的干扰;
可萃取金属数据
聚合物对激光能量的激活可提供高
对比度、无溶剂的
高速鉴别
定制母粒和即用型配方可提供
透明和不透明颜色,同时允许激光
传输/吸收
PE和PP的新一代快速成核剂;提
高尺寸稳定性,热性能和机械性能
降低湿蒸汽透过率(MVTR)
HDPE即用型配方
吸湿母粒
减少 BCT(血液收集管)中因氧传
输造成的真空损失,并保护试剂免
受氧化降解
在290-450nm波长范围内阻挡紫
外线,对透明度没有影响;保护光
敏试剂
自检/即时检验
(POCT)
用于实验室自动化/
鉴别编码的着色剂
颜色—低迁移/减
低干扰
颜色—生物相容
性评估
透明PP
PP、ABS、
PC/ABS的抗静电
性能
激光焊接可
快速、可靠地组装
一系列聚合物
半结晶聚合物
的成核剂,例如
HDPE、PP、POM
防止氧气进入的
PET吸氧剂
透明容器(PP、
PE、PETG、COP)
中的紫外光防护
防潮以改善屏障
激光打标的UDI替
代油墨印刷/贴标
PP、ABS、PC和
高温聚合物的颜
色,符合UL认证
为各种聚合物提供多种颜色,能够
为您的工艺提供适用的即用型配方
或母粒
降低不符合现行和拟定法规(如
IVDR)的风险
即用型解决方案/母粒支持针对电器
外壳的UL要求
永久性/非迁移性即用型配方;不受
相对湿度(%)影响的快速静电衰
减时间
不含山梨醇,最大限度地减少潜在
迁移
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版权所有© 2021埃万特公司。
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/idea/considerations-when-printing-and-marking-fluoropolymers
Are printing/marking solutions available that meet Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislative standards?
Yes, there are solutions available that will help your company and its applications stay compliant with the REACH legislation.
Avient offers a full range of colorant or additive concentrates, and specialty compounds, based on these materials, as well as the necessary printing and marking inks.
https://www.avient.com/sites/default/files/2023-07/TPEs for Healthcare Industry Bulletin.pdf
Versaflex™ & Versalloy™ Specialty Engineered Materials
Thermoplastic Elastomers for Healthcare Applications
Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications,
Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5.
Avient makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability
for particular applications, or the results obtained or obtainable using the information.
Avient makes no warranties or
guarantees respecting suitability of either Avient’s products or the information for your process or end-use application.
https://www.avient.com/oasis-discharge-tips
The ink film must reach cure temperature and remain at cure temperature long enough to drive off all the moisture in the image area.
Avient recommends that goods printed with ZFS Discharge are washed or tagged due to the presence of formaldehyde.
https://www.avient.com/sites/default/files/2020-07/tpes-for-healthcare-industry-bulletin.pdf
Versaflex™ & Versalloy™ Specialty Engineered Materials
Thermoplastic Elastomers for Healthcare Applications
Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications,
Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5.
Avient makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability
for particular applications, or the results obtained or obtainable using the information.
Avient makes no warranties or
guarantees respecting suitability of either Avient’s products or the information for your process or end-use application.
https://www.avient.com/products/engineered-polymer-formulations/flame-retardant-formulations/bergamid-fr-non-halogen-flame-retardant-formulations
RoHS Compliance
Browse and download our literature to learn more about Avient solutions and services.
Discover Avient's portfolio of flame retardant engineered materials available in a range of polymers
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001
standard.
This document is property of Avient
2.0 Avient Global Quality Policy
Document
Page 5 of 10
Only the electronic version of this document in ETQ is the controlled version of the document.
This document is property of Avient
3.0 Supplier Management
3.1 Supplier Quality Management System
Avient expects its supply base to maintain a certified QMS at all of its locations and those of its
affiliated companies in accordance with the requirements of ISO 9001, ISO 13485, or IATF 16949
(depending on supplier commodity), as applicable.
https://www.avient.com/company/policies-and-governance/global-policy-anti-bribery-and-anti-corruption
Avient Canada ULC
Avient Quality Policy
Global ISO Certificate Library
https://www.avient.com/products/vinyl-formulations/vinyl-powder-coating-and-dip-molding/core-vinyl-powder-coating-formulations
We can formulate and certify your vinyl powder for end-use automotive, FDA, UL, ASTM, NSF, military or customer-specific applications.
Browse and download our literature to learn more about Avient solutions and services.
https://www.avient.com/products/engineered-polymer-formulations/conductive-signal-radiation-shielding-formulations/colorant-chromatics-conductive-formulations-0
Reach out to our experienced technical experts to find the right solution for your application.
Avient Wire & Cable Industry Bulletin
Overview of how Avient serves wire & cable customers, highlighting both power and data cables technologies