https://www.avient.com/sites/default/files/2024-09/Terms and Conditions of Sale for Denmark.pdf
Upon
receipt of a notice of an alleged claim, Seller may
suspend all further deliveries.
4.
https://www.avient.com/sites/default/files/2022-04/Asia SEM Healthcare Product Selection Guide_CN.pdf
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
应用:
VERSAFLEX™ CL与DYNAFLEX™
热塑性弹性体
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
USP VI级,ISO 10993,
食品接触
USP VI级,ISO 10993,
US食品接触
USP VI级,ISO 10993,
食品接触
USP VI级,ISO 10993
USP VI级,ISO 10993,
食品接触
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、
辐射灭菌
高压灭菌、环氧乙烷、
辐射灭菌
应用:
VERSALLOY™ HC与VERSAFLEX™ HC
热塑性弹性体
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
辐射灭菌
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
应用:
VERSAFLEX™ CL与DYNAFLEX™
热塑性弹性体
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。
https://www.avient.com/sites/default/files/resources/Terms%2520and%2520Conditions%2520of%2520Sale%2520for%2520Mexico%2520%2528English%2520and%2520Spanish%2520Language%2520Version%2529.pdf
Seller may discontinue any
Product sold hereunder, after delivery of the same, at
any time, unless Buyer and Seller have otherwise
agreed in writing.
4.
El Vendedor podrá descontinuar
cualquier Producto vendido, después de la entrega del
mismo, en cualquier momento, a menos que el Comprador y
el Vendedor hayan acordado diferente por escrito.
4.
Either party may suspend performance
hereunder (except to pay for Product already received)
in the event of: (1) acts of God, fire, explosion, flood,
hurricanes; (2) strikes, lockouts or other industrial
disturbances or riots; (3) war, declared or undeclared,
or acts of terrorism; (4) compliance with any Federal,
state, provincial, municipal or military law, regulation,
order, or rule, foreign or domestic, including priority,
rationing, allocation or preemption orders or
regulations, or cancellation of Seller’s or Buyer’s
license to operate its plant; (5) catastrophic failure of
facilities used to manufacture Product, interruption or
shortage of transportation, labor, power, fuel or raw
materials; (6) total or partial shutdown due to Seller’s
normal plant turnaround; or (7) any other cause or
causes of any kind or character reasonably outside the
control of the party failing to perform, whether similar
or dissimilar from the enumerated causes (a “force
majeure”).
https://www.avient.com/products/advanced-composites/continuous-fiber-composite-tape-laminates-and-barstock/polystrand-continuous-fiber-tapes-laminates
4
https://www.avient.com/content/terms-conditions-carriage
4.
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Table of Contents
1.0 Organizational Context ..............................................................................................................................................3
1.1 Purpose ..................................................................................................................................................................3
1.2 Scope ......................................................................................................................................................................3
2.0 Avient Global Quality Policy ......................................................................................................................................4
3.0 Supplier Management ...............................................................................................................................................5
3.1 Supplier Quality Management System..................................................................................................................5
3.2 Performance Evaluation ........................................................................................................................................5
3.3 Supplier On-Site Audit ...........................................................................................................................................5
3.4 Product and Process Changes ................................................................................................................................6
4.0 Supplier Quality Expectations ...................................................................................................................................6
4.1 Raw Material(s), Packaging and Shipping .............................................................................................................6
4.2 Nonconforming Material, Containment, and Supplier Corrective Action ............................................................6
4.3 Contingency / Disaster Recovery Plan...................................................................................................................7
4.4 Sub-Tier Supplier Controls .....................................................................................................................................7
5.0 Avient Business Expectations ....................................................................................................................................8
Additional functional area documentation ........................................................................................................................8
6.0 References..................................................................................................................................................................9
7.0 Definitions and Acronyms .........................................................................................................................................9
Approved
Corporate : Manual
Document #: DOC-02627 Revision: 6
Document
Owners:
Kyle Johnson Effective Date: Mar 20, 2024
Title: Global Supplier Quality Manual
Page 3 of 10
Only the electronic version of this document in ETQ is the controlled version of the document.
Approved
Corporate : Manual
Document #: DOC-02627 Revision: 6
Document
Owners:
Kyle Johnson Effective Date: Mar 20, 2024
Title: Global Supplier Quality Manual
Page 4 of 10
Only the electronic version of this document in ETQ is the controlled version of the document.
https://www.avient.com/sites/default/files/resources/TRA%2520-%25202016%2520Annual%2520Report%2520for%252017%2520Tideman.pdf
lang=En&n=FD9B0E51-1
https://ec.ss.ec.gc.ca/auth/en/Services
about:/
about:/
about:/
General Information
Substance List
CAS RN Substance Name Releases Releases (Speciated VOCs) Disposals Recycling Unit
NA 01 Antimony (and its compounds) 0.0004 N/A N/A N/A tonnes
NA 02 Arsenic (and its compounds) 0.0007 N/A N/A N/A kg
103231 Bis(2ethylhexyl) adipate 0.0106 N/A N/A N/A tonnes
117817 Bis(2ethylhexyl) phthalate 0.0283 N/A N/A N/A tonnes
85687 Butyl benzyl phthalate 0.0008 N/A N/A N/A tonnes
NA 14 Zinc (and its compounds) 0.0000 N/A N/A 0.0002 tonnes
Applicable Programs
CAS RN Substance Name NPRI ON MOE TRA ON MOE Reg 127/01
First report for
this substance to
the ON MOE TRA
NA 01 Antimony (and its compounds) Yes
NA 02 Arsenic (and its compounds) Yes
103231 Bis(2ethylhexyl) adipate Yes
117817 Bis(2ethylhexyl) phthalate Yes
85687 Butyl benzyl phthalate Yes
NA 14 Zinc (and its compounds) Yes
Position:
EHS Manager
Telephone:
5192150535
Email:
brian.greer@polyone.com
Contact Type
Certifying Official
Name:
Najat Kamal
Position:
EHSQ specialist
Telephone:
5148089920
Email:
najat.kamal@polyone.com
Number of employees:
45
Activities for Which the 20,000Hour Employee
Threshold Does Not Apply:
None of the above
Activities Relevant to Reporting Dioxins,
Furans and Hexacholorobenzene:
None of the above
Activities Relevant to Reporting of Polycyclic
Aromatic Hydrocarbons (PAHs):
Wood preservation using creosote: No
Is this the first time the facility is reporting to
the NPRI (under current or past ownership):
No
Is the facility controlled by another Canadian
company or companies:
No
Did the facility report under other
environmental regulations or permits:
No
Is the facility required to report one or more
NPRI Part 4 substances (Criteria Air
Contaminants):
No
Was the facility shut down for more than one
week during the year:
No
Operating Schedule Days of the Week:
Mon, Tue, Wed, Thu, Fri
Usual Number of Operating Hours per day:
24
Usual Daily Start Time (24h) (hh:mm):
00:00
General Information about the Substance Releases and Transfers of the Substance
CAS RN
Substance
Name
Was the substance
released onsite
The substance will be reported as the sum of
releases to all media (total of 1 tonne or less)
1 tonne or more of a Part 5 Substance
(Speciated VOC) was released to air
NA 01
Antimony (and
its compounds)
Yes Yes No
NA 02
Arsenic (and its
compounds)
Yes No No
103231
Bis(2ethylhexyl)
adipate
Yes Yes No
117817
Bis(2ethylhexyl)
phthalate
Yes Yes No
85687
Butyl benzyl
phthalate
Yes Yes No
NA 14
Zinc (and its
compounds)
Yes No No
General Information about the Substance Disposals and Offsite Transfers for Recycling
CAS RN
Substance
Name
Was the substance disposed of (onsite or off
site), or transferred for treatment prior to final
disposal
Is the facility required to report on disposals of
tailings and waste rock for the selected
reporting period
Was the substance
transferred offsite for
recycling
NA 01
Antimony
(and its
compounds)
No No No
NA 02
Arsenic (and
its
compounds)
No No No
103231
Bis(2
ethylhexyl)
adipate
No No No
117817
Bis(2
ethylhexyl)
phthalate
No No No
85687
Butyl benzyl
phthalate
No No No
NA 14
Zinc (and its
compounds)
Yes No No
General Information about the Substance Nature of Activities
CAS RN Substance Name Manufacture the Substance Process the Substance Otherwise Use of the Substance
NA 01 Antimony (and its compounds) For onsite use/processing As a reactant As a byproduct
NA 02 Arsenic (and its compounds) For onsite use/processing As a reactant As a byproduct
103231 Bis(2ethylhexyl) adipate For onsite use/processing As a reactant As a byproduct
117817 Bis(2ethylhexyl) phthalate For onsite use/processing As a reactant As a byproduct
85687 Butyl benzyl phthalate For onsite use/processing As a reactant As a byproduct
NA 14 Zinc (and its compounds) For onsite use/processing As a reactant As a byproduct
Onsite Releases Releases to air
CAS RN Substance Name Category Basis of Estimate Detail Code Quantity
NA 02 Arsenic (and its compounds) Stack or Point Releases O Engineering Estimates 0.0000 kg
NA 14 Zinc (and its compounds) Stack or Point Releases O Engineering Estimates 0.0000 tonnes
Onsite Releases Releases to air Total
CAS RN Substance Name Total Releases to Air
NA 02 Arsenic (and its compounds) 0.0000 kg
NA 14 Zinc (and its compounds) 0.0000 tonnes
Onsite Releases Releases to land
CAS RN Substance Name Category Basis of Estimate Detail Code Quantity
NA 02 Arsenic (and its compounds) Other O Engineering Estimates 0.0007 kg
Onsite Releases Nature of Other Land Release
CAS RN Substance Name Nature of Other Land Release
NA 02 Arsenic (and its compounds) Landfill disposal
CAS RN Substance Name Nature of Other Land Release
Onsite Releases Releases to land Total
CAS RN Substance Name Total Releases to Land
NA 02 Arsenic (and its compounds) 0.0007 kg
Total Quantity Released (All Media)
CAS RN Substance Name Category Basis of Estimate Detail Code Quantity
NA 01 Antimony (and its compounds) Total Quantity Released O Engineering Estimates 0.0004 tonnes
103231 Bis(2ethylhexyl) adipate Total Quantity Released O Engineering Estimates 0.0106 tonnes
117817 Bis(2ethylhexyl) phthalate Total Quantity Released O Engineering Estimates 0.0283 tonnes
85687 Butyl benzyl phthalate Total Quantity Released O Engineering Estimates 0.0008 tonnes
Onsite Releases Total
CAS RN Substance Name Total releases
NA 02 Arsenic (and its compounds) 0.0007 kg
NA 14 Zinc (and its compounds) 0.0000 tonnes
Onsite Releases Quarterly Breakdown of Annual Releases
CAS RN Substance Name Quarter 1 Quarter 2 Quarter 3 Quarter 4
NA 01 Antimony (and its compounds) 25 25 25 25
NA 02 Arsenic (and its compounds) 25 25 25 25
103231 Bis(2ethylhexyl) adipate 25 25 25 25
117817 Bis(2ethylhexyl) phthalate 25 25 25 25
85687 Butyl benzyl phthalate 25 25 25 25
Onsite Releases Reasons for Changes in Quantities Released from Previous Year
CAS RN Substance Name Reasons for Changes in Quantities from Previous Year Comments
103231 Bis(2ethylhexyl) adipate No significant change (i.e.
https://www.avient.com/sites/default/files/2022-02/MEVOPUR Bio-based Solutions Application Bulletin_JP.pdf
ISO13485認証取得の4拠点で製造し、グロー
バルで同品質の製品を安定的に供給致します。
3)生殖器用インプラントまたは避妊具、または
(4)人間の生命を支え、維持する永久的(30日以上)移植された医療機器の重要な構成要素。
https://www.avient.com/sites/default/files/2020-08/wilflex-ghosting-tips-techniques.pdf
Heat – Excessive heat will create a situation which
the garment will retain the heat for a longer period
of time.
4.
https://www.avient.com/sites/default/files/2021-06/edgetek-et8900-cr-technical-bulletin.pdf
ACTIVE INGREDIENTS RESISTANCE RATING
Clorox® Disinfecting Wipes 5813-79 Quaternary ammonium +++++ +++++ +++++ ++ +++ ++++
Formula 409®
Heavy Duty Degreaser
N/A
Lauramine oxide,
ethanolamine
+++++ +++++ +++++ + ++ +++
Lysol® All-Purpose Cleaner 777-66 Quaternary ammonium +++++ +++++ +++++ + + ++
$$$ $$$ $$$$ $ $$$ $
MATERIAL COMPARISON WITH COMMON CONSUMER DISINFECTANTS
FR
P
C/
AB
S
FR
P
C/
P
ET
FR
P
C/
P
BT
Ed
ge
te
k™
E
T8
90
0
CR
Ed
ge
te
k™
E
T8
90
0
H
I C
R
Ed
ge
te
k™
E
T8
92
0
FR
C
RCRITERIA FOR RESISTANCE RATING
+ strength and elongation at yield retention between 90-110%
+ strength and elongation at yield retention between 75-125%
+ no statistically significant reduction in elongation at break (p < 0.05)
+ visual observation score of 4 or better (minor/no crazing, no cracks)
+ samples survived disinfectant exposure in strain jig
Lysol® is a trademark of Reckitt Benckiser LLC
Formula 409® is a trademark of The Clorox Company
Clorox® is a trademark of The Clorox Company
An independent, A2LA-accredited lab tested the following polymers with various disinfectants to help
customers choose the material suitable for their specific application requirements.