https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB
MANUFACTURER
N E E D L E H U B C O L O R S
• RAL and Pantone® colors available in palette to align with
ISO 6009 color standard
• Opaque and transparent polypropylene selections
available in both masterbatch and ready-to-use precolors
• Raw materials pre-tested to ISO 10993 and USP Class VI
medical device guidelines
• Certified formulations available globally
• Provided RAL and Pantone colors as
required
• Developed custom polypropylene
formulations to meet specific opacities
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the value chain
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Colors
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-09/avient2020sustainabilityreport-9-2-21.pdf
Combined,
these facilities have a total of 205 certifications to an ISO or Management System and
standards.
For our sensitive applications, in
addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing
Processes (GMP). 100% of our facilities producing those sensitive applications and
warehouses are GMP audited within a 3–year period.
Our goal in 2021 is to develop processes
and procedures and a position statement on critical customer information, and fully
prioritize the product portfolio in all critical markets/materials.
75
ISO Certified
Facilities
ZERO
Product
Recalls
Major Non-Conformances
at ISO Sites
Sustainability Report | 2020 59Sustainability Report | 2020 59
Management Approach:
Supplier Collaboration
Avient’s value extends not only to consumers through specialty products,
but beyond the boundaries of our own processes and operations.
https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
HYPODERMIC NEEDLE
MANUFACTURER
N E E D L E H U B , C O V E R A N D
S H I E L D
• Compliance to ISO 6009 color coding for single use hypodermic
needle
• Biocompatibility of all component materials
• Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf
https://www.avient.com/sites/default/files/2025-01/ISO 16949 Tossiat%2C France.pdf
https://www.avient.com/sites/default/files/resources/Polyolefins%2520Product%2520Selection%2520Guide.pdf
Offers a high level of stiffness and
heat resistance as well as excellent
impact resistance
Product Code - - - PP5410 B1 PP5420 B1 PP5430 B5 PP5440 B1
Reinforcement % - - - 10 20 30 40
Specific Gravity 73°F (23°C) - ASTM D792 0.96 1.05 1.14 1.23
Tensile Strength Yield psi ASTM D638 8000 10000 11500 13000
MPa ISO 527 55 69 79 90
Tensile Elongation Break % ASTM D638 8 2 2 2
Flexural Modulus 73°F (23°C) psi ASTM D790 525,000 795,000 850,000 1,000,000
MPa ISO 178 3600 5450 5800 7550
Notched Izod
73°F (23°C) ft-lb/in ASTM D256 1.10 1.30 1.50 1.60
kJ/m2 ISO 180 6.00 7.25 8.25 8.50
Heat Deflection 66 psi °F ASTM D648 280 305 310 315
°C ISO 75 138 152 154 157
264 psi °F ASTM D648 250 280 290 300
°C ISO 75 121 138 143 149
Linear Shrinkage
1/8 in wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
3.2 mm wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
Product Code - - - PP7410
A241
PP7420
B77
PP6430
A206-UV
PP6435
Reinforcement % - - - 10 20 30 35
Specific Gravity Yield - ASTM D792 0.98 1.05 1.14 1.17
Tensile Strength Yield psi ASTM D638 5300 9200 9000 13300
MPa ISO 527 37 64 62 92
Tensile Elongation Break % ASTM D638 8 4 4 4
Flexural Modulus 73°F (23°C) psi ASTM D790 240,000 420,000 695,000 810,000
MPa ISO 178 1650 2900 4800 5600
Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 5.0 1.60 1.60 2.50
kJ/m2 ISO 180 27.5 9.00 9.00 14.00
Heat Deflection 66 psi °F ASTM D648 298 313 297 300
°C ISO 75 144 156 152 149
264 psi °F ASTM D648 210 272 265 288
°C ISO 75 92 133 128 142
Linear Shrinkage
1/8 in wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
3.2 mm wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
Maxxam™ Glass Fiber Reinforced
Homopolymer Polypropylene
Maxxam™ Glass Fiber
Reinforced Copolymer
71.866.POLYONE www.polyone.com
Product Code - - - PP5312
PP5320
A285
PP5330
A123
PP5340
B2
Reinforcement % - % - 12 20 30 40
Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.24
Tensile Strength Yield psi ASTM D638 4800 4400 3600 4900
MPa ISO 527 31 30 32 38
Tensile Elongation Yield % ASTM D638 5 4 4 3
Break % ASTM D638 20 15 20 10
Flexural Modulus 73°F (23°C) psi ASTM D790 285,000 380,000 355,000 460,000
MPa ISO 178 1950 2600 2450 3200
Notched Izod
73°F (23°C) ft-lb/in ASTM D256 0.6 0.55 1.5 0.60
kJ/m2 ISO 180 3.30 3.00 8.25 3.30
Heat Deflection 66 psi °F ASTM D648 235 255 230 280
°C ISO 75 113 124 110 138
264 psi °F ASTM D648 135 156 150 180
°C ISO 75 57 69 66 82
Linear Shrinkage
1/8 in wall % - 1.4–1.9 1.0–1.4 1.1–1.5 0.6–1.0
3.2 mm wall % - 1.4–1.9 1.0–1.4 1.1–1.5 0.6–1.0
Offers improved stiffness and heat
deflection as well as outstanding
dimensional stability.
Provides heat stabilization
• Excellent balance of properties
• Natural, black or custom colors
Product Code - - - PX5430 B1 PX5435 B1 PX5440 B1 PX5450 B1
Reinforcement Type - - - Glass Glass Glass Glass
Reinforcement % - % - 30 35 40 50
Specific Gravity 73°F (23°C) - ISO 1183 1.13 1.18 1.23 1.35
Tensile Strength Yield MPa ISO 527 102 105 113 130
Flexural Modulus 73°F (23°C) MPa ISO 178 6500 8000 9400 11,500
Notched Izod Impact 73°F (23°C) kJ/m2 ISO 180 9.4 9.3 11.0 12.0
Heat Deflection 264 psi °C ISO 75 152 152 153 154
Product Code - - - PP5120 B270-LO
MFR g/10 min ISO 1133 12
Tensile Modulus MPa ISO 527 3320
Tensile Stress Yield MPa ISO 527 32
Tensile Elongation Yield % ISO 527 4.6
Tensile Elongation Break % ISO 527 17
Flexural Modulus MPa ISO 178 3000
Charpy Impact 73°F (23°C) kJ/m2 ISO 179/1eU 38
Heat Aging 150°C h VW 44045 700 hr
VOC µg/g VDA 278 23.5
Fog µg/g VDA 278 30.5
Carbon Emissions µgC/g VDA 277 18
Odor Grade VDA 270 B3 3
10
Maxxam™ Filled
& Reinforced
A range of melt flows to process well in
sheet extrusion, thermoforming, profile
extrusion and blow molding operations
Product Code - - - PE4125
Reinforcement
- - - Talc
Reinforcement
- % - 25
Specific
73°F (23°C) - ASTM D792 1.15
Tensile
Yield psi ASTM D638 4050
MPa ISO 527 28
Tensile
Yield % ASTM D638 10
Break % ASTM D638 40
Flexural
73°F (23°C) psi ASTM D790 270,000
MPa ISO 178 1850
Notched
73°F (23°C) ft-lb/in ASTM D256 3.5
kJ/m2 ISO 180 20.0
Heat
66 psi °F ASTM D648 190
°C ISO 75 88
264 psi °F ASTM D648 115
°C ISO 75 46
12
www.polyone.com
Copyright © 2019, PolyOne Corporation.
https://www.avient.com/sites/default/files/2023-10/ISO 13485-2016 cert_expire 28Feb2025_Avient%5B28%5D.pdf
2
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Certificate
Avient Colorants Singapore Pte Ltd
8 Third Chin Bee Road
Jurong Industrial Estate
618684 Singapore
Singapore
Scope
Administration, Site management, Manufacture,
Laboratory, Procurement, Maintenance,
infrastructure, Warehouse and Transport
Normative base
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no. 45483 Validity 01. 03. 2022 – 28. 02. 2025
Issue 01. 03. 2022
A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION
VEHICLE BATTERY
MANUFACTURER
C E L L P A C K C O O L I N G T U B E
• Comply with ISO 3384-1:2011 for TPE compression set
• Comply with ISO 11359-2:1999 standard for linear thermal
expansion
• Good ethanediol resistance
• Good sealing performance
• Customized a Shore 60A hardness TPE
formulation with good physical property
retention
• Achieved good compression set and bonding
performance with PA12
• Qualified thermal expansion by customer
• Provided excellent ethanediol resistance under
both low and high temperature conditions
KEY REQUIREMENTS
CHEMICAL RESISTANCE + SEALING
LEARN MORE
OnFlex™ TPE Custom Formulation
Copyright © 2023, Avient Corporation.
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form
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/resources/safety-data-sheets?page=5092
Geon(TM) DB4842B ISO STABLE HI VISC