https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=18
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=18
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=28
MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield
https://www.avient.com/news/avient-s-new-recycled-tpe-grades-support-greater-use-recycled-materials-automotive-vehicles
¹Product Carbon Footprint values are calculated with Avient’s third-party certified PCF Calculator by TÜV Rheinland according to ISO 14067.
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Dynaflex™ G2706 28A USP Class VI, ISO 10993,
Food contact EtO Soft translucent grade,
grippy feel
Dynaflex™ G2711 43A USP Class VI, ISO 10993,
Food contact EtO Highly colorable solution,
grippy feel, low compression set
Versaflex™
CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993,
US Food contact EtO Clear boilable grades;
ABS, PC bondable
Versaflex™ G2705 N 60A USP Class VI, ISO 10993,
Food contact EtO/Steam High resilience,
low compression set
Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled
ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent
Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
OVERMOLDING FOR
ERGONOMICS
• Adds good tactile surface with soft-touch feel
• Available in a variety of color effects and
textures
• Improves grip, cushion, and comfort
• Enhances functional performance like sealing
properties, vibration damping, oxygen
barrier, and scratch and abrasion resistance
• Reduces assembly costs, good processability
• Offers excellent adhesion to a wide range of
substrates
• Glucometers
• Medical tools overmolds
• Injector pens
• Analysis devices
VERSALLOY™ HC & VERSAFLEX™ HC TPEs
SEALING & RESEALING
• Rubbery feel and soft touch
• No coring, good puncture, and
resealability in static stoppers
• Meets low coefficient of friction
requirements in dynamic seals
• Low extractables
• Suitable to overmold onto polyolefins
• Sealing and resealing septum
• Seals and sanitary gaskets
• Syringe plungers and tips
MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versalloy™
HC 9210-45N 45A USP Class VI EtO Good processability,
HC 9210-55N 55A USP Class VI EtO Good processability,
HC 9210-70N 70A USP Class VI EtO Good processability,
HC 9220-43N 43A USP Class VI,
ISO 10993-4/5 EtO Extrusion grade,
high temperature resistance
Versaflex™
HC 2110-35N 34A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Resealing, elevated comp set
Versaflex™
HC 2110-57B 57A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Low stiction
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
HIGH CLARITY
GRADES WITHOUT
PLASTICIZERS
• Water clear grades formulated without
phthalate plasticizers
• Meets medical regulatory USP Class VI and
ISO 10993-4,5
• Food contact and FDA compliant
• Autoclave and radiation stable
• Low extractable
• High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70
Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820
Flexural Strength (MPa) 80 90 104 86 68 68
Flexural Modulus (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 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0
UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0
UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2
COMPETITIVE MATERIAL COMPARISON
ENGINEERED POLYMER FORMULATIONS
FOR HEALTHCARE
TRILLIANT™ HC THERMOPLASTICS
The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges
of medical devices and equipment.
https://www.avient.com/sites/default/files/2023-10/LubriOne Product Selection Guide.pdf
Steel – Static 0.25 0.46 0.18 0.15 0.12 0.19 0.11 0.14 0.13 0.24 0.17 0.17
Impact
Notched Izod Impact (23°C,
3.18 mm, Injection Molded) J/m ASTM D256A 41 64(6) 110 107 107 70 80 37 37 75 – 69
Thermal Properties
Heat Deflection Temperature ASTM D648
0.45 MPa °C 215(6) – 250 215 216 184 152 151(6) 153(6) 218(6) – –
1.8 MPa °C 65(6) 239(7) 244(6) 210 210 75 94 81.1(6) 88 197(6) – 135(5)
Electrical Properties
Surface Resistivity ohms/sq ASTM D254 – – – 1.30x1012 1.9x1012 5.2x1012 – – – – – 1.0x109
Dielectric Strength (Short Time) kV/mm – – 8.5 – – – – – – – – –
Flammability
Flame Rating Class UL 94 HB – – HB HB HB – HB – – – –
LubriOne™ Internally Lubricated Formulations
NOTES (1) Type I, 5.1mm/min
(2) Type I, 21.3 mm/min
(3) Type I, 50 mm/min
(4) Type I, 5.1mm/min, Break
(5) 3.2 mm thick, Unannealed
(6) 6.35 mm thick, Unannealed
(7) 3.2 mm thick, Annealed
PRODUCT DESCRIPTION UNITS TEST
METHOD
5024 RS HI
5021 RS S1
5021 RS X2
5019 X1
LB6700-
5001 RS AF
Black
NN-
000/01M
Black SO
REC
LB6600-
5030 RS
Grey
LB3300-
5010 RS
LB3300-
5005 RS
REC
LB3220-
5001 RS C
Natural X1
5010 GP
Grey
5006 RS PE
5004 RS PE
LB4200-
5022 Black
LB4200-
5023
Base Polymer PA 6 PA6/PA66 PA66 PBT PC PKE POM
Lubricant UHMWPE1 UHMWPE UHMWPE UHMWPE UHMWPE MoS22 Graphite UHMWPE UHMWPE UHMWPE Graphite UHMWPE UHMWPE MoS2 UHMWPE
Filler type GF10 GF30 GF30 GF50 GF50 Unfilled GF33 GF20 MI20 GF10 Unfilled GF20 GF30 Unfilled Unfilled
General Properties
Specific Gravity g/cm3 ISO 1183 1.18 1.35 1.39 1.55 1.58 1.14 1.44 1.42 1.46 1.23 1.26 1.34 1.43 1.4 1.35
Mechanical Properties
Tensile Modulus (23°C) MPa ISO 527-1 4250 9500 9000 15500 16600 3500 10600 6300 3330 4000 1630 5300 9250 2470 2150
Tensile Strength (Yield, 23°C) MPa ISO-527-2 97 150 160 205 200 85 164 102 55 60 60 108 99.1 55 50
Tensile Elongation (Break, 23°C) % ISO-527-2 12 2.5 3 2.7 2.4 3.4 2.0 4.2 8 2.5 46 3.7 1.5 11 11
Flexural Strength (23°C) MPa ISO 178 103 – – 285 265 108 215 127 78 85 38 155 117 73 68
Flexural Modulus (23°C) MPa ISO 178 3250 – – 12400 11100 2690 9000 4700 3000 3100 1380 4600 5450 2210 2070
Impact
Charpy Notched Impact Strength
(23°C, Injection Molded) kJ/m^2 ISO 179 14 12 10 15 10 3 6 7.7 4.3 12 15 10 7.6 8 5
Charpy Unnotched Impact
Strength (23°C, Injection Molded) kJ/m^2 ISO 179 82 55 61 75 60 65 50 47 69 - NB 63 36 NB NB
Thermal Properties
Deflection Temperature Under Load
1.8 Mpa, Unannealed °C ISO 75-2/A 107 – – 204 – 73 235 – – – 90 210 204 86 80
Cofficient of Friction (CoF) & Wear Rate
CoF vs.
https://www.avient.com/sites/default/files/2021-08/avient-cdp-climate-change-questionnaire-2021.pdf
In addition, Avient has externally
certified EHS&S management systems, including ISO 9001 worldwide.
ISO 14001,
Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of
facilities.
In addition, Avient has ISO 9001
worldwide and ISO 14001 and ISO 50001 certification at many facilities.
https://www.avient.com/sites/default/files/2022-10/Tossiat-IATF 16949-2016 POLYONE FRANCE SAS.pdf
and the applicable customer specific requirements
Revision:1
For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France
None
Bureau Veritas Certification Certificate N°: FR072877- IATF
IATF Certificate N°: 442787
Date Of Expiration: 01-February-2025
Date Of Certification: 02-February-2022
PRODUCT(S) DELIVERED
colour with additive concentrates for thermoplastic resins
and speciality compounds obtained by mixing and extrusion
PERMITTED EXCLUSION(S)
SCOPE
Design and manufacturing
Bureau Veritas Certification certify that the Quality Management System of the above organisation
has been audited and found to be in accordance with the requirements of
Route de la Vavrette, 01250, TOSSIAT France
PolyOne France Tossiat
Awarded to
Certificate of Approval
REMOTE SUPPORT FUNCTION(S)
(The official document is in English.
Revision:1
For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France
Bureau Veritas Certification Certificate N°: FR072877- IATF
IATF Certificate N°: 442787
Date Of Expiration: 01-February-2025
Date Of Certification: 02-February-2022
Route de la Vavrette, 01250, TOSSIAT France
PolyOne France Tossiat
Awarded to
Appendix to the Certificate of Approval
Name Address Scope
AVIENT
LUXEMBOURG
ROUTE DE BASTOGNE, 19, 9836,
POMMERLOCH Luxembourg
Logistic, Supplier Management,
Purchasing
PolyOne Europe
Logistics
7 rue Blériot, 4460, GRACE HOLLOGNE
Belgium
Warehousing
Polyone Europe ul.
https://www.avient.com/sites/default/files/2023-06/ISO 45001 Suzhou - GLS.pdf
https://www.avient.com/sites/default/files/2021-11/suzhou-colormatrix-iso-900185.pdf