https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-needle-hubs-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
可将颜色与添加剂相结合,以增强产品性能
和防护性能
•
•
•
•
法规支持
经过预测试的原材料:
- 美国药典(USP)23,第87和88章(VI类)
萃取和生物学评价
- ISO 10993,第4、5、10、11和18部分,
萃取和生物学评价
- 美国药典和欧洲药典中针对USP 、
ICH Q3D可萃取金属和EP3.1聚烯烃的测试的
其他监管支持信息
FDA器械主文件
食品接触符合FDA/EU*要求
•
•
•
针头的标称外径
(mm) 颜色说明 RAL 潘通色号 透明产品代码 不透明产品代码
0.4 中灰色 7035 423 C PP7M665125 PP7M665127
0.45 褐色 8017 7588 C PP8M665294 PP8M665296
0.5 橘黄色 2003 173 C PP2M665298 PP2M665300
0.55 中紫色 4005 7676 C PP4M665290 PP4M665292
0.6 深蓝色 5010 288 C PP5M665894 PP5M665896
0.7 黑色 9005 黑色 C PP9M664950 PP9M664952
0.8 深绿色 6001 7483 C PP6M665687 PP6M665689
0.9 黄色 1021 115 C PP1M665211 PP1M665213
1.1 乳白色 1015 7401 C PP0M665290 PP0M665292
1.2 粉色 3015 502 C PE3M665725 PP3M665727
适用医疗保健使用限制—见下文。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/resources/PolyOne%2520India%2520Terms%2520and%2520Conditions%2520of%2520Sale%2520of%2520Products.May%25202016.pdf
Seller may discontinue any Product sold hereunder at
any time, unless Buyer and Seller have otherwise agreed in writing.
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/sites/default/files/resources/NOVEL_THERMOPLASTIC_ELASTOMERS_FOR_UNIVERSAL_OVERMOLDING_ON_DISSIMILAR_THERMOPLASTICS.pdf
Novel TPE materials that can overmold
onto various engineering plastics also were reported elsewhere (2-4).
Krishna Venkataswamy, Jiren Gu and Walter Ripple, “A Novel Robust Polyamide Overmold
Thermoplastic Elastomer, John Simons,” RAPRA 2005
4.
https://www.avient.com/investor-center/news/polyone-announces-third-quarter-2017-results
for the third quarter driven primarily by 5% organic expansion and recent specialty acquisitions, which added 4%.
$3 million to $4 million
Attachment 4
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-ophthalmic-closures-application-bulletin-cn.pdf
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发布的注册药品管理档案(III类)和/或医
疗器械管理档案
食品接触符合FDA/EU*要求
•
•
•
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
变更控制记录的不限于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
标准母粒在PE载体中提供,可根据要求在PP
中提供
可以采用针对应用选择的特定树脂提供预着色
配方
•
•
•
•
•
药物类型 颜色说明 潘通色号参考 埃万特产品代码(PE基)
肾上腺素能激动剂组合 浅绿色 373 C PE6M176349
肾上腺素能激动剂 紫色 2583 C PE4M176057
抗感染药 棕褐色 467 C PE8M176130
非甾体类抗炎药 灰色 冷灰色 4 C PE7M176184
甾体类抗炎药 粉色 197 C PE3M176237
免疫调节剂类抗炎药 橄榄绿 5763 C 按要求提供
β-受体阻滞剂 黄色 黄色 C PE1M176160
β-受体阻滞剂组合 深蓝色 281 C PE5M176272
碳酸酐酶抑制剂 橘黄色 1585 C PE2M176089
细胞毒素 黑色 6 C PL9M176008
缩瞳剂 深绿色 348 C PE6M176267
散瞳剂和睫状肌麻痹剂 红色 1797 C PE3M176236
前列腺素类似物 绿松石 326 C PE5M176273
适用医疗保健使用限制—见下文。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2023-07/Versaflex HC _ Versaflex HC BIO - BT Series Product Overview.pdf
KEY CHARACTERISTICS
• Meets critical need for thermal weldability
and kink resistance
• Minimizes extractables during processing
• Provides excellent tensile strength
• Complies with USP VI and ISO 10993-4, -5, -11
certifications
• Suitable for gamma and autoclave
sterilization methods
• Bio-based grade option formulated with nearly
40% Gen 1 biomass content
PRODUCT OVERVIEW
1.844.4AVIENT
www.avient.com
Copyright © 2023, Avient Corporation.
https://www.avient.com/resources/safety-data-sheets?page=4264
SHALE W/AS
https://www.avient.com/resources/safety-data-sheets?page=718
FRUCTIS TRANSL LT GREEN w/UV
https://www.avient.com/sites/default/files/2023-08/Avient General Purchase Conditions.pdf
Avient shall not be
responsible for delayed payments in case
invoices are sent by Supplier after the period
under (ii) above.
3.5 Unless otherwise agreed between the
Parties, Supplier will execute the purchasing
process (including but not limited to the
Purchase Order, order confirmation, shipping
notification, invoicing) through electronic
communication.
4.
Indemnification and Liability
13.1 Supplier will indemnify, defend, and
hold harmless Avient, its officers, directors,
employees, agents, successors, assigns,
customers and other vendors, and their
respective present and future directors, officers,
employees and agents from and against all
liabilities, damages, claims, losses, costs, fees,
expenses, penalties and injuries of any kind or
nature (including court costs and reasonable
attorneys’ and experts’ fees), arising out of or
resulting in any way from: 1) Any breach by
Supplier or a Supplier contractor/agent of any
representation, warranty or obligation under the
Agreement; 2) Any product liability and/or
Avient Terms and Conditions of Purchase for Goods and/or Services
product safety issue(s) related to the Goods; 3)
Personal injury or death related to the Goods
and/or Services hereunder; 3) Any loss or
damage to property attributable to the Goods or
Services; 4) Any negligent act, omission or willful
misconduct of Supplier or a or Supplier
contractor/agent; and 5) The failure of Supplier’s
Goods or Services to comply with all
international, state, federal and local laws, rules
and regulations.
Supplier shall
be responsible for and shall indemnify Avient
against all liability and loss in connection with
payment of all taxes incident to its performance
of this Agreement.
20.
https://www.avient.com/sites/default/files/2020-11/2020-trilliant-hc8910-hc8920-processing-guide.pdf
Drying
Conditions English (°F) Metric (°C)
Temperature 180°F 80°C
Duration 2-4 Hours
Moisture Level
Allowable 0.05%–0.20%
Processing
Screw Speed Typical screw speeds are recommended
Back Pressure Lower back pressure is recommended
Pack Pressure 60 - 80% of max injection pressure
Hold Pressure 40 - 60% of max injection pressure
Cool Time 10 - 30 seconds (depends on part geometry and dimensional stability)
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