https://www.avient.com/sites/default/files/2024-08/Avient 2023 Sustainability Report_6.pdf
Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third
parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and
Responsible Care®.
This methodology was developed in accordance with ISO 14067:2018 for product carbon
footprint and is aligned with ISO 14040/140440 for life cycle analysis.
locale=en
https://www.carbon-minds.com/
https://www.certipedia.com/quality_marks/0000084994?
https://www.avient.com/sites/default/files/2025-06/IATF16949 -2025.5.21~2028.5.20 EN -EM.pdf
1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com
Page 1 of 2
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
11229-2006-CHN-IATF
IATF Certificate No:
0573810
Valid:
21 May 2025 – 20 May 2028
This is to certify that the management system of
PolyOne - Suzhou, China
EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China 215024 (USI:
CF4943)
and, if applicable, the remote supporting locations as mentioned in the Appendix accompanying
this Certificate
has been found to conform to the Quality Management System standard:
IATF 16949:2016
This certificate is valid for the following scope:
DESIGN AND MANUFACTURE OF PLASTIC COMPOUNDING MATERIAL
EXCLUSION: NONE
http://www.dnv.com
Certificate no.: 11229-2006-CHN-IATF
IATF Certificate No: 0573810
Place and date: Katy, TX, 22 May 2025
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance USA Inc., 1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com
Page 2 of 2
Appendix to Certificate
PolyOne - Suzhou, China
Remote Support Locations included in the certification are as follows:
Site Name Site Address RSL Activities
Certification
Body
Avient China Co., Ltd.
https://www.avient.com/company/policies-and-governance/avients-human-rights-policy
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/avients-position-water-stewardship
Global ISO Certificate Library
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Plan%2520Summary.pdf
lang=En&n=3C401D5C-1
http://www.ec.gc.ca/default.asp?
lang=En&n=BD3CE17D-1
http://www.ec.gc.ca/default.asp?
n=29E6BF9F-1&lang=en
http://www.ec.gc.ca/default.asp?
https://www.avient.com/products/polymer-additives/healthcare-additives/mevopur-healthcare-functional-additives
Get Help Now
+1-866-737-2066
Global network of ISO 13485 certified manufacturing sites
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission
https://www.avient.com/sites/default/files/2022-04/Asia SEM Healthcare Product Selection Guide_CN.pdf
Asia SEM Healthcare Product Selection Guide_CN3.31-1
埃万特特种
工程材料-针对
医疗保健行业
产品选购指南
应用于医疗器械的材料及其对患者安全所产生的影响需要仔细斟
酌。
Versaflex™ OM3060
PP包覆成型 硬度 法规 灭菌 特性
28A 环氧乙烷 柔软的半透明材料,粘性好
43A 环氧乙烷 高度可着色的解决方案,
粘性好,不易压缩变形
42A/ 50A 环氧乙烷 透明的耐高温级材料;
ABS、PC可粘合
60A 环氧乙烷/蒸汽 弹性高,不易压缩变形
20A-90A 环氧乙烷 用途广泛,无填充
ABS,PC包覆成型 硬度 法规 灭菌 特性
40A USP VI级,ISO 10993 环氧乙烷 半透明
60A USP VI级,ISO 10993 环氧乙烷 透明
VERSAFLEX™ CL与DYNAFLEX™
包覆成型,符合人体
工程学设计
触感柔软,有利于形成良好的表面
有多种颜色效果和纹理可供选择
提高抓握力、缓冲力和舒适度
提高性能表现,如密封性能、减震、隔氧、
耐刮擦和耐磨性能
降低装配成本,加工性能良好
可牢固包覆于各种基材上
血糖仪
医用工具包覆成型
注射笔
分析仪器
Dynaflex™ G2706
Dynaflex™ G2711
Versaflex™
CL2242 & CL2250
Versaflex™ G2705 N
Versaflex™ HC3810
Versaflex™ OM1040
US食品接触
USP VI级,ISO 10993
材料描述 硬度 法规 灭菌 特性
45A USP VI级
55A USP VI级
70A USP VI级
43A 环氧乙烷
34A
USP VI级,
ISO 10993-4/5
FDA,USP VI级,
ISO 10993
57A
挤出级,耐高温
再密封,压缩变形性能提高
摩擦低
Versalloy™ HC 9210-55N
Versalloy™ HC 9210-70N
Versalloy™ HC 9220-43N
Versaflex™ HC 2110-35N
Versaflex™ HC 2110-57B FDA,USP VI级,
ISO 10993
环氧乙烷 加工性能良好,表面光洁、美观
环氧乙烷
环氧乙烷
加工性能良好,表面光洁、美观
加工性能良好,表面光洁、美观
高压灭菌、环氧乙烷、
高压灭菌、环氧乙烷、
VERSALLOY™ HC与VERSAFLEX™ HC
密封和再密封
柔软的橡胶质感
无抽芯,静态推塞被刺穿后再密封性良好
满足动态密封的低摩擦系数要求
可萃取物含量低
适合在聚烯烃上包覆成型
密封和密封隔膜
密封件和卫生垫圈
注射器推塞和塞头
Versalloy™ HC 9210-45N
材料描述 硬度 法规 灭菌 特性
65A/ 75A/ 84A
54A
67A
高压灭菌器
透明度高,不含增塑剂,无油
工作温度高,可高温灭菌
环氧乙烷、辐射灭菌
Versaflex™ HC MT555
Versaflex™ HC BT218
VERSAFLEX™ CL与DYNAFLEX™
高透明度级,不含增塑剂
无色透明级,配方不含邻苯二甲酸酯增塑剂
符合医疗法规USP VI级和ISO 10993-4、5的
要求
食品接触用并符合FDA标准
可高压灭菌和辐射灭菌
可萃取物含量低
透明度高(雾度50 4.1, 100 4.5, 100 4, 70 6, 70
拉伸模量(MPa) 2200 2700 2600 2350 1820 1820
挠曲强度(MPa) 80 90 104 86 68 68
挠曲模量(MPa) 2500 2700 2500 2300 1980 1590
HDT:0.45、1.8(MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70
UL-94等级,3.0mm 5VA V-0 5VA V-0 HB V-0
UL-94等级,1.5mm V-0 V-0 5VB V-0 HB V-0
UL-94等级,0.75mm V-1 V-2 V-0 无 无 V-2
竞争材料对比
医疗保健特种工程聚合物配方
TRILLIANT™ HC热塑性塑料
Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。
ST5200-8030
ESD BK001 1 5 27 52 1980 42 E3
ST5200-8035
ESD BK001 1 20 22 37 1460 150 E3
TRILLIANT™ HC
导电配方
导电性一致确保可重复使用部件的性能,同时
最大限度减少导电性不一致引发的相关问题
高流量和易加工性有利于薄壁零件填充和多腔
工具,从而缩短循环时间并且降低每单位部件
的成本
优异的耐用性在减少破裂的同时,还可降低由
此产生的报废相关成本
不易形成飞边,外观得到改善,且可减少吸头
内外的液体滞留,从而提高准确度并降低交叉
污染的可能性
通过高强度生产的部件,其刚性和耐翘曲性也
更高,再次最大限度降低因报废产生的相关成
本
• 导电移液吸头
+86.21.60284888
www.avient.com
版权所有©2022 埃万特公司。
https://www.avient.com/sites/default/files/2023-08/Maxxam BIO Bio-Based Polyolefin Formulations Product Bulletin.pdf
KEY CHARACTERISTICS
Formulated with bio-based resin and/or
10–50% filler from renewable plant sources,
Maxxam BIO formulations:
• Reduce product carbon footprint
• Achieve equivalent performance to standard
polyolefin formulations
• Provide good stiffness, durability, impact
resistance and UV stability
• Deliver good surface finish and are easy to color
• Enable customized performance characteristics
depending on application need
• Offer food contact compliance
MARKETS AND APPLICATIONS
Maxxam BIO formulations are suitable for use across
many industries and applications where traditional
polyolefin materials are used, including:
• Transportation Interior Applications -
Decorative profiles, trunk side liners, pillars,
T-cup
• Industrial - Structural parts, furniture
• Consumer - Household goods, personal care
items, packaging, office supplies, food contact
applications
• Electrical and Electronic – Housings, buttons,
junction boxes
SUSTAINABILITY BENEFITS
• Formulated with bio-based resin and/or
10–50% natural filler
• Utilize natural filler from renewable plant
sources including olive seed based powder
and cellulose fiber
• Offer a lower product carbon footprint
compared to traditional petroleum-based
feedstock
• Can be recycled at end of life
PRODUCT BULLETIN
CHARACTERISTICS UNITS
Maxxam BIO
MX5200-5036
Natural FD
Maxxam BIO
MX5200-5030
Natural FD
Maxxam BIO
MX5200-5030
Natural FD X1
Maxxam BIO
MX5200-5001
Maxxam BIO
MX5200-5033
Maxxam BIO
MX5200-5034
Maxxam BIO
MX5200-5035
Filler/Reinforcement Unfilled Unfilled Unfilled 30%
Glass Fiber
10%
20%
30%
Density
(ISO 1183) g/cm 0.90 0.90 0.90 1.12 0.96 1.03 1.12
Tensile Modulus
(ISO 527-1) @ 23°C MPa 1500 1000 1000 6400 1350 1650 2100
Tensile Stress
(ISO 527-2) @ 23°C MPa 27.0 20.0 20.0 75.0 13.0 14.0 15.0
Tensile Strain
at Break
% 5 50 50 3.0 50 37 18
Charpy Notched
(ISO 179) kJ/m 5 20 25 10 12 10 10
CHARACTERISTICS UNITS
Maxxam BIO
MX5200-5023
RS HS HI
Natural 70
Maxxam BIO
MX5200-5025
RS HS
Natural 70
Maxxam BIO
MX5200-5004
RS HS
Maxxam BIO
MX5200-5003
RS
Maxxam BIO
MX5200-5009
RS HS Natural
70
Maxxam BIO
MX5200-5024
RS HS
Maxxam BIO
MX5200-5022
RS HS
Filler/Reinforcement
15%
Olive Seed
Based
25%
Olive Seed
Based
30%
Olive Seed
10%
35%
Olive Seed
5%
15%
Olive Seed
17%
Glass Fiber/
20%
Olive Seed
20% Glass/
10%
Olive Seed
20%
Density
(ISO 1183) g/ccm 1.00 1.15 1.10 1.07 1.09 1.25 1.10
Tensile Modulus
(ISO 527-1) @ 23°C MPa 1750 2000 2700 2500 3800 3500 4100
Tensile Stress
at Break
MPa 21.0 20.0 30.0 20.0 40.0 35.0 42.0
Tensile Strain
at Break
% 24 5 3 5 3 4 2
Notched Izod
(ISO 180) kJ/m 15 7 3 2 5 15 7
MAXXAM BIO POLYOLEFINS – BIO-BASED RESIN – TECHNICAL PERFORMANCE
MAXXAM BIO POLYOLEFINS – OLIVE SEED BASED FILLER – TECHNICAL PERFORMANCE
CHARACTERISTICS UNITS
Maxxam BIO
MX5200-5029 NF HI
UV Black X1
Maxxam BIO
MX5200-5032 NFS
UV Natural
Maxxam BIO
MX5200-5020 NF/NFS
UV Natural X1
Maxxam BIO
MX5200-5016 NF
Natural
Filler/Reinforcement 10% Cellulose Fiber 20% Cellulose Fiber 30% Cellulose Fiber 40% Cellulose Fiber
Density
(ISO 1183) g/ccm 0.95 1.00 1.02 1.07
Tensile Modulus
ISO 527-1) @ 23°C MPa 1550 1750 2640 3600
Tensile Stress at Break
(ISO 527-2) @ 23°C MPa 33 30 48 55
Tensile Strain at Break
(ISO 527-2) @ 23°C % 8 12 9 4
Charpy Notched Impact
Strength (ISO 179/1eA) kJ/m2 5 6 5 5
Charpy Unnotched Impact
Strength (ISO 179/1eU) kJ/m2 33 49 38 30
MAXXAM BIO POLYOLEFINS – CELLULOSE FIBER FILLER – TECHNICAL PERFORMANCE
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2022-07/Mevopur Standard Colors Product Bulletin-CN.pdf
Mevopur Standard Colors Product Bulletin-CN3.26-1
MEVOPUR™ 着色剂
医疗应用的标准颜色
关键特性
监管支持
预先测试的原材料库,包括:
- ISO 10993
- USP , (class VI)
- USP
- ICHQ3D 可提取金属
- EuPh
向FDA提交的DMF / MAF文档适用于所有标
准颜色
医疗应用
医疗设备,例如导管,手术和牙科器械或药
物输送设备
药物包装,包括药瓶或瓶子
血液分析诊断或体外诊断(IVD)
产品公告 & 色卡
MEVOPUR 着色剂解决方案组合专为当今日益复
杂的医疗保健应用而设计。
™
在三个通过ISO 13485认证的医疗产线生产
全球统一的配方,提供全球一致性和供应链
保障
提供文件化的变更控制
原料指纹图谱和常规批次测试
多种标准颜色缩短产品开发时间
产品组合里符合标准的颜色用于:
- 注射针头ISO 6009
- 眼科容器盖(美国眼科学院 / AAO -
American Academy of Ophthalmology)
颜色 潘通色
参照 PE 基料 PP 基料 透明PP 基料 PEBA 基料 PC 基料 ABS 基料*
— PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
颜色可能与显示的实际颜色有所不同。
https://www.avient.com/resources/safety-data-sheets?page=5624
MORADO OPACO PANTONE Q260-1-3 EN PS
PLATA 472-30411-1 CO (2)
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)