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SPECIALTY POLYMERS High-Performance Polymers for Medical Equipment

High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

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Page 1: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

SPECIALTYPOLYMERS

High-Performance Polymers for

Medical Equipment

Page 2: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

Advanced Polymer Solutions for Medical Equipment

Solvay can be an added resource to your design and engineering team. We can provide the product development and technical and regulatory support you need to grow your business globally.

• Material recommendations

• Designing with plastics

• Moldflow® process modeling

• Finite element analysis

• Fabrication and assembly techniques

• Product testing and failure analysis

• Global regulatory submission assistance

• On-site materials training

• On-site processing support

Page 3: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

High-Performance Polymers for Medical Equipment / 3

Broadest selection of high-performance thermoplastics for medical equipment.

Global technical and regulatory support tailored to meet the unique demands of your project.

With over 25 years of experience as a leading materials supplier to the healthcare industry, Solvay provides the reliability, experience and innovation that medical device manufacturers expect from their partners.

Our dedicated healthcare team provides the product development, technical and regulatory support you need to grow your business globally.

Medical Grade High-Performance PolymersFor limited exposure applications having less than 24 hours contact with bodily fluids and tissue.

Today’s broad range of medical equipment requires different performance requirements that benefit from our many different polymers.

• Tailored levels of chemical resistance

• High stiffness and impact strength

• ISO 10993:1 biocompatibility testing

• Excellent surface finish

• Transparent, opaque and gamma-stabilized colors

• FDA Master Access Files (MAF) available

High-Performance PolymersFor applications that have no contact with bodily fluids and tissues.

OEMs can also benefit from the proven performance of our products used in diverse end-use applications including automotive, smart devices, electrical/electronics, and the chemical processing industry.

• Wide-ranging combinations of chemical, thermal and mechanical properties

• Superior surface aesthetics

• Metal-like stiffness

• Excellent electrical properties

• Flame retardancy (UL 94 V-0)

Page 4: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

4 \ High-Performance Polymers for Medical Equipment

Medical Grade High-Performance PolymersFor limited exposure applications having less than 24 hours contact with bodily fluids and tissue.

Udel® PSU polysulfone

• High-heat resistance

• Good chemical resistance

• Good hydrolytic stability

• Good drop impact resistance and strength

• Opaque and transparent colors

Veradel® HC PESU polyethersulfone

• Higher heat resistance than Udel® PSU

• Good chemical resistance

• High flow rate

• Highest stiffness of all sulfone polymers

• Transparent

Radel® PPSU polyphenylsulfone

• Extended high-heat resistance

• Withstands more than 1,000 cycles of steam sterilization

• Excellent chemical resistance

• Superior toughness and impact properties

• Opaque and transparent colors

AvaSpire® PAEK polyaryletherketone

• Better chemical resistance than Radel® PPSU

• Good fatigue and temperature resistance

• Good impact resistance

• Glass and carbon fiber reinforced grades

• Excellent aesthetics and colorability

KetaSpire® PEEK polyetheretherketone

• Industry’s highest performing thermoplastic

• Best-in-class chemical resistance

• Excellent fatigue and heat resistance

• Good impact resistance

• Glass and carbon fiber reinforced grades

Ixef® PARA polyarylamide

• Single-use application material of choice

• Very high stiffness and strength

• High flow for excellent moldability

• Exceptional surface finish

• Suitable for metal replacement

• Opaque gamma-stabilized colors

Page 5: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

High-Performance Polymers for Medical Equipment / 5

High-Performance PolymersFor applications that have no contact with bodily fluids and tissues.

Amodel® PPA polyphthalamide

• Outperforms standard nylons

• Higher strength and stiffness at elevated temperatures

• Better retention of properties in humid environments

• Greater resistance to a broader range of chemicals

Kalix® HPPAhigh-performance polyamide

• High strength and rigidity

• High flow for complex, thin-walled components

• Low and slow moisture absorption

• Excellent surface finish

Ryton® PPSpolyphenylene sulfide

• Prolonged high-temperature service

• Excellent chemical resistance

• Precision mold to tight tolerances

• Inherently flame retardant

Torlon® PAIpolyamide-imide

• Very high strength and stiffness

• Exceptional high-heat wear resistance

• Excellent chemical resistance

• Superior toughness

• Inherently flame retardant

Solef® PVDFpolyvinilydene fluoride

• Excellent resistance to solvents, acids and bases

• High strength at high temperatures

• Very high purity

• Filtration membranes

Halar® ECTFEethylene chlorotrifluoroethylene

• Outstanding chemical resistance

• Inherently flame retardant

• Anti-corrosion liners

Tecnoflon® FKMfluoroelastomers

• High-temperature sealing

• Excellent chemical and stain resistance

• Silky touch for wearable smart devices

• Colorability

Hyflon® PFAperfluoroalkoxy alkanes

• Excellent chemical and heat resistance

• Smooth surface and anti-stick properties

• Wire and cable insulation

Algoflon® PTFEpolytetrafluoroethylene

• Chemically inert

• Outstanding heat resistance

• Self-lubricating

• Low-friction tubing

Page 6: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

6 \ High-Performance Polymers for Medical Equipment

Performance Properties Processing Regulatory Sterilization

Co

mp

atib

ility

w

ith

Dis

infe

ctan

ts

Imp

act

Str

eng

th

Hig

h S

tiff

nes

s

Aes

thet

ics,

S

urf

ace

Fin

ish

Tran

spar

ency

Co

lora

bili

ty

Met

al R

epla

cem

ent

UL

94 V

-0

Lo

w D

iele

ctri

c C

on

stan

t

Mo

ldin

g

Ext

rusi

on

Th

erm

ofo

rmin

g

ISO

109

93

Co

mp

lian

t G

rad

es

Ste

am S

teri

lizat

ion

10

cyc

les,

18

min

, 134

°C

Ste

am S

teri

lizat

ion

10

0 cy

cles

, 18

min

, 134

°C

Ste

am S

teri

lizat

ion

1,

000

cycl

es, 1

8 m

in, 1

34 °C

Eth

ylen

e O

xid

e,

100

cycl

es

Hig

h-E

nerg

y G

amm

a R

adia

tio

n, 4

0 kG

y

Typical Applications

Medical Grade High-Performance Polymers

Udel® PSU •(1) •• • ••• ••• ••• •• yes •• ••• ••• •• yes yes yes no yes yes Connectors, couplings, fittings, housings, microtubing

Veradel® HC PESU • •• • ••• ••• ••• •• yes •• ••• ••• •• yes yes yes no yes yes (2) Sensor housings, transparent housings

Radel® PPSU ••• • ••• ••• ••• ••• yes •• ••• ••• •• yes yes yes yes yes yes Handles and knobs, couplings, fittings, cases and trays

AvaSpire® PAEK ••• ••• •• •• n/a • ••• yes •• ••• •• yes yes yes yes yes yes Battery case for powered surgical tools, holders, structural components

KetaSpire® PEEK ••• ••• •• •• n/a • yes •• ••• •• • yes yes yes yes yes yes Chip holder in genome sequencer, microtubing

Ixef® PARA •• •• ••• ••• n/a •• ••• yes •• ••• n/a n/a yes yes no no yes yes Monitor frames and cases, housings, enclosures

High-Performance Polymers

Amodel® PPA •• •• •• • n/a • ••• yes •• ••• • •• no n/a n/a n/a n/a n/a Housings, handles

Ryton® PPS ••• • • n/a • ••• yes •• ••• •• •• no n/a n/a n/a n/a n/a Electrical connectors, electronic circuit brakers

Kalix® HPPA •• •• •• •• n/a •• •• – – ••• n/a n/a no n/a n/a n/a n/a n/a LCD bezel and CG frame, monitor frames and cases

Torlon® PAI •• •• •• n/a n/a n/a •• no •• • •• n/a no n/a n/a n/a n/a n/a High-speed, high-heat motor and pump components, low-friction coatings

Solef® PVDF ••• • n/a •• n/a • •• yes ••• ••• ••• • no n/a n/a n/a n/a n/a Piping systems for dialysis water, filtration membranes

Halar® ECTFE ••• • n/a •• • • • yes ••• ••• •• • no n/a n/a n/a n/a n/a Corrosion protection coatings, wire and cable jacketing

Tecnoflon® FKM ••• n/a n/a ••• • ••• n/a yes ••• ••• • n/a yes n/a n/a n/a n/a n/a Wristbands of wearable devices, seals, O-rings, membranes

Hyflon® PFA ••• n/a n/a •• • • •• yes ••• ••• •• •• no n/a n/a n/a n/a n/a Wire and cable insulation, sheathing, jacketing

Algoflon® PTFE ••• n/a n/a •• n/a n/a n/a yes ••• • n/a n/a yes n/a n/a n/a n/a n/a Filtration membranes, gaskets, O-rings, seals

(1) Outperforms polycarbonate (PC)(2) Compatible with high-energy gamma radiation, but drops in ductility

• Good

•• Better

••• Best

Superior

n/a Not applicable

Page 7: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

High-Performance Polymers for Medical Equipment / 7

Performance Properties Processing Regulatory Sterilization

Co

mp

atib

ility

w

ith

Dis

infe

ctan

ts

Imp

act

Str

eng

th

Hig

h S

tiff

nes

s

Aes

thet

ics,

S

urf

ace

Fin

ish

Tran

spar

ency

Co

lora

bili

ty

Met

al R

epla

cem

ent

UL

94 V

-0

Lo

w D

iele

ctri

c C

on

stan

t

Mo

ldin

g

Ext

rusi

on

Th

erm

ofo

rmin

g

ISO

109

93

Co

mp

lian

t G

rad

es

Ste

am S

teri

lizat

ion

10

cyc

les,

18

min

, 134

°C

Ste

am S

teri

lizat

ion

10

0 cy

cles

, 18

min

, 134

°C

Ste

am S

teri

lizat

ion

1,

000

cycl

es, 1

8 m

in, 1

34 °C

Eth

ylen

e O

xid

e,

100

cycl

es

Hig

h-E

nerg

y G

amm

a R

adia

tio

n, 4

0 kG

y

Typical Applications

Medical Grade High-Performance Polymers

Udel® PSU •(1) •• • ••• ••• ••• •• yes •• ••• ••• •• yes yes yes no yes yes Connectors, couplings, fittings, housings, microtubing

Veradel® HC PESU • •• • ••• ••• ••• •• yes •• ••• ••• •• yes yes yes no yes yes (2) Sensor housings, transparent housings

Radel® PPSU ••• • ••• ••• ••• ••• yes •• ••• ••• •• yes yes yes yes yes yes Handles and knobs, couplings, fittings, cases and trays

AvaSpire® PAEK ••• ••• •• •• n/a • ••• yes •• ••• •• yes yes yes yes yes yes Battery case for powered surgical tools, holders, structural components

KetaSpire® PEEK ••• ••• •• •• n/a • yes •• ••• •• • yes yes yes yes yes yes Chip holder in genome sequencer, microtubing

Ixef® PARA •• •• ••• ••• n/a •• ••• yes •• ••• n/a n/a yes yes no no yes yes Monitor frames and cases, housings, enclosures

High-Performance Polymers

Amodel® PPA •• •• •• • n/a • ••• yes •• ••• • •• no n/a n/a n/a n/a n/a Housings, handles

Ryton® PPS ••• • • n/a • ••• yes •• ••• •• •• no n/a n/a n/a n/a n/a Electrical connectors, electronic circuit brakers

Kalix® HPPA •• •• •• •• n/a •• •• – – ••• n/a n/a no n/a n/a n/a n/a n/a LCD bezel and CG frame, monitor frames and cases

Torlon® PAI •• •• •• n/a n/a n/a •• no •• • •• n/a no n/a n/a n/a n/a n/a High-speed, high-heat motor and pump components, low-friction coatings

Solef® PVDF ••• • n/a •• n/a • •• yes ••• ••• ••• • no n/a n/a n/a n/a n/a Piping systems for dialysis water, filtration membranes

Halar® ECTFE ••• • n/a •• • • • yes ••• ••• •• • no n/a n/a n/a n/a n/a Corrosion protection coatings, wire and cable jacketing

Tecnoflon® FKM ••• n/a n/a ••• • ••• n/a yes ••• ••• • n/a yes n/a n/a n/a n/a n/a Wristbands of wearable devices, seals, O-rings, membranes

Hyflon® PFA ••• n/a n/a •• • • •• yes ••• ••• •• •• no n/a n/a n/a n/a n/a Wire and cable insulation, sheathing, jacketing

Algoflon® PTFE ••• n/a n/a •• n/a n/a n/a yes ••• • n/a n/a yes n/a n/a n/a n/a n/a Filtration membranes, gaskets, O-rings, seals

(1) Outperforms polycarbonate (PC)(2) Compatible with high-energy gamma radiation, but drops in ductility

Page 8: High-Performance Polymers for Medical Equipment...• Flame retardancy (UL 94 V-0) 4 \ High-Performance Polymers for Medical Equipment Medical Grade High-Performance Polymers For limited

www.solvay.com

Safety Data Sheets (SDS) are available by emailing us or contacting your sales representative. Always consult the appropriate SDS before using any of our products.

Neither Solvay Specialty Polymers nor any of its affiliates makes any warranty, express or implied, including merchantability or fitness for use, or accepts any liability in connection with this product, related information or its use. Some applications of which Solvay’s products may be proposed to be used are regulated or restricted by applicable laws and regulations or by national or international standards and in some cases by Solvay’s recommendation, including applications of food/feed, water treatment, medical, pharmaceuticals, and personal care. Only products designated as part of the Solviva® family of biomaterials may be considered as candidates for use in implantable medical devices. The user alone must finally determine suitability of any information or products for any contemplated use in compliance with applicable law, the manner of use and whether any patents are infringed. The information and the products are for use by technically skilled persons at their own discretion and risk and does not relate to the use of this product in combination with any other substance or any other process. This is not a license under any patent or other proprietary right.

All trademarks and registered trademarks are property of the companies that comprise the Solvay Group or their respective owners.© 2018, Solvay Specialty Polymers. All rights reserved. D 08/2017 | R 01/2018 | Version 1.3

Specialty Polymers

Worldwide [email protected] Lombardia, 20 20021 Bollate (MI), Italy

Americas [email protected] McGinnis Ferry RoadAlpharetta, GA 30005, USA

South [email protected] Galvão Bueno, 5.505- Batistini09842-080 - São Paulo, SP - Brazil

Asia [email protected] Jindu Road Shanghai, China 201108