Materials. Powering Ideas.

North America

High Performance
Medical Grade Resins
for Single- & Multiple-Use Devices
and Equipment Housings
Trinseo
Medical Application
Policy
Trinseo produces medical grade resins under stringent
quality guidelines and controlled conditions. We
strive to understand our customers’ needs and
expectations regarding patient safety, reliability,
and compliance with regulatory requirements, and
to provide biocompatible resins according to ISO
10993 standards. Additionally, Trinseo medical grade
resins are subject to management of change and
“formula lock” that involve notifying customers of an
upcoming change followed by locking that formula
for an extended period of time.
Based on Trinseo’s interest in collaborating with
its customers, Trinseo has developed an internal
process for reviewing customer requests for use
of ISO 10993-certified materials in certain medical
applications.
Through this review process, we determine whether
or not Trinseo will support the use of Trinseo
materials in the proposed medical application based
on 1.) Device Category, 2.) Type of Body Contact, and
3.) Duration of Body Contact utilizing the ISO 10933-
1:2009 guidelines, Biological Evaluation of Medical
Devices Part 1: Evaluation & Testing.
1
As part of the Trinseo review process, Trinseo will
consider the proposed medical applications based on
the following guidelines:
Category A (Limited Exposure): Trinseo may support
the use of Trinseo materials in medical applications
involving transient or limited contact with internal
human body fluids or tissues, where “transient”
means less than 24 hours.
Category B (Prolonged Exposure): Trinseo may
support the use of Trinseo materials in medical
applications involving contact with internal human
body fluids or tissues for up to 29 days.
Category C (“Permanent” Contact): Trinseo may
support the use of Trinseo materials in medical
applications involving contact with internal human
body fluids or tissues for greater than 29 days.
However, in no event will Trinseo support the use of
Trinseo materials in medical applications classified
as implant devices or birth control devices, defined
as applications designed specifically to promote or
interfere with human reproduction.
If customers, distributors or resellers fail to comply
with this Policy, and Trinseo becomes aware of said
situation, then Trinseo business units shall take steps
required to immediately preclude further sales to
that end use.
In all of the categories above, Trinseo will exercise
its business judgment and conduct appropriate
assessments when forming supplier/customer
relationships and supplying materials. Trinseo has
not designed or tested its products with respect
to all possible uses in medical applications. While
Trinseo will commit to meet product specifications
and quality standards agreed with the customer, it
is the responsibility of the medical device or
pharmaceutical manufacturer to determine the
suitability of the parts and raw materials, including
Trinseo products, used in final products to ensure
safe, suitable, lawful and technical compliance for
the intended end use.
Turning Ideas
into Reality

About Trinseo
Trinseo is a leading global materials company and Fast Facts Trinseo
manufacturer of plastics, latex and rubber, dedicated
to collaborating with customers to deliver innovative More than 70 years of technology and marketplace
and sustainable solutions. Trinseo’s technology leadership
is used by customers in industries such as home More than 2,100 employees in 27 countries
appliances, automotive, building & construction, 67 manufacturing units in 19 production sites
carpet, consumer electronics, consumer goods,
2 major business divisions: Performance Materials,
electrical, lighting, medical, packaging, paper &
Basic Plastics & Feedstocks
paperboard, rubber goods and tyres.

Widespread Manufacturing Assets

Stade, Germany
Schkopau, Germany
Terneuzen, Netherlands
Tessenderlo, Belgium
Norrkoeping, Sweden

Midland, MI Hamina, Finland

Zhangjiagang, China

Boehlen , Germany Ulsan, South Korea

Rheinmuenster, Germany
Livorno, Italy

Ehime, Japan
(Joint Venture)
Dalton, GA
Hsinchu, Taiwan
Tsing Yi, Hong Kong

Merak, Indonesia
Plastics Limao, Brazil
Latex Guaruja, Brazil
Synthetic Rubber

2
Supporting the
Medical Industry
Trinseo has been supporting the medical devices
market with compounded products for single- and
multiple-use devices and equipment housings for
nearly three decades. As a manufacturer focused
on resin quality and product stewardship, we
distinguish ourselves by working with our customers
strategically, collaboratively and confidentially to
solve complex material challenges.
3
Our products are offered under the brand names
CALIBRETM Polycarbonate Resins, CALIBRETM
MEGARADTM Polycarbonate Resins, EMERGETM
Advanced Resins and MAGNUMTM ABS Resins. Each
product shown can be customized to meet specific
needs using our technology building blocks and our
cross-industry expertise. Most of our grades have
been biocompatibility tested; selected products have
been US FDA Master Access File listed.
Products Available
for Medical Applications

Pre-colored PC/ABS &

Glass-filled PC for PC/PET with ignition
surgical equipment that resistance, biocompatibility
White ABS & PC
requires a high degree & chemical resistant
PC with for portable
of structural support & features for device
gamma & equipment
biocompatitbility housings
Transparent PC for e-beam housings
single-use radiation
applications resistance for
sterilization
needs

Brand Polymer Family Features Recommended Applications

CALIBRETM PC • Transparent • Fluid & drug delivery: syringes, stopcocks,

• Opaque luers, etc.
• Custom colors available
• Biocompatibility

CALIBRETM PC-GF • Opaque • Surgical devices: handles &

(Glass-filled) • High rigidity housings
• Biocompatibility

CALIBRETM PC • Transparent • Fluid & drug delivery: syringes, stopcocks,

MEGARADTM • Gamma & E-beam radiation luers, etc.
resistance • Renal care: blood filter housings, dialyzer
• Biocompatibility housings, etc.

EMERGETM PC/ABS • Outstanding chemical resistance • Monitoring device: housings & covers
PC/PET • Ignition resistance
• Limited biocompatibility

MAGNUMTM ABS • Superior natural whiteness • Portable device housings: diabetes

• Pre-colored resins for selected management equipment, glucose meters,
products pumps, insulin pens, etc.
• Excellent lot-to-lot consistency

4
Trinseo’s Product Offerings
DTUL
Tensile Elongation @ Flexural Instrumented Vicat Softening Light
Density, Melt Flow Rate, Impact (1.8MPa,
Strength Break Modulus Dart Impact Temperature Transmission UL Rating (s)
Grade Features g/cm3 (g/10 min) (23°C, J/m) Unannealed, Applications
@ Yield (%) (MPa) (23°C, J) (°C) (%)
°C)
ASTM D 792 ASTM D 1238 ASTM D 638 ASTM D 638 ASTM D 790 ASTM D 256 ASTM D 3763 ASTM D 648 ASTM D 1525 AST< D 1003 UL 94
CALIBRETM Polycarbonate Resins (EtO & Steam Sterilization)
2060-3 1.2 3 (300°C/1.2kg) 60 / 72.4 150 2410 910 90 129 156 89 - Fluid & drug delivery:
1.5mm V2 syringes, stopcocks, luers, etc.
2061-3 High ESCR, High toughness 1.2 3 (300°C/1.2kg) 60 / 72 150 2410 960 93.8 132 151 89
3.0mm HB
1.5mm V2
2061-6 1.2 6 (300°C/1.2kg) 62.1 / 68.3 150 2410 850 89.3 129 156 89
3.0 mm HB
Good toughness, 1.5mm V2
2061-15 1.2 15 (300°C/1.2kg) 62.1 / 68.3 150 2410 750 81.3 122 148 89
Balanced features 3.0 mm HB
1.5mm V2
2061-22 Easy processing 1.2 22 (300°C/1.2kg) 60 / 65.5 120 2410 750 72.3 126 152 89
3.0 mm HB
1.5mm V2 Surgical devices: handles, housings, etc.
5101-8 Good modulus 1.27 8 (300°C/1.2kg) 62.1 / 60.7 6.0 3170 80 40.1 134 160 Opaque
3.0 mm V0

1.5mm V2
5101-15 High rigidity 1.27 15 (300°C/1.2kg) 62.1 / 60.7 6.0 3170 80 40.1 134 160 Opaque
3.0 mm V0

1.5mm V2
5201-12 Very good modulus 1.36 12 (300°C/1.2kg) 82.7 / 82.7 3.0 4830 110 46.3 138 159 Opaque
3.0 mm V0
CALIBRETM MEGARADTM Polycarbonate Resins (Gamma & Electron Beam Sterilization)
Fluid & drug delivery: syringes, stopcocks, luers, etc.
Lipid-resistant
2081-6LR 1.2 6 (300°C/1.2kg) 65.5 / 68.3 130 2410 850 89.3 129 151 85 -
Injection Molding

2081-15 Injection Molding 1.2 15 (300°C/1.2kg) 62.1 / 68.3 150 2410 750 81.3 122 148 85 -

Renal care: blood filter housings, dialyzer housings

2081-22 High Flow Injection Molding 1.2 22 (300°C/1.2kg) 64.1 / 46.9 180 - 750 - 123 - 85 -

Designed for oxygen-free

2091-15 1.2 15 (300°C/1.2kg) 62.1 / 68.3 150 2410 750 81.3 122 148 85 -
irradiation

EMERGETM Advanced Resins

Monitoring devices: housings & covers
PC/ABS 7100 MED General Purpose PC/ABS 1.11 25 (260°C/5.0kg) 50.3 / - 50 2430 480 - 95 133 Opaque 1.0 mm HB

PC/ABS 7700 & Ignition-resistant and UV 1.5 mm V0

1.17 11 (230°C/3.8kg) 60 / 48.3 65 2690 480 - 79.4 104 Opaque
7710 resistance 2.0mm 5VB

PC/ABS 7750 &

Durability, toughness 1.187 3 (230°C/3.8kg) 67 / 62 137.7 2560 730 - 87 113 Opaque 1.5 mm V0
7760

PC/PET 9100CR Chemical-resistant 1.23 8.5 (260°C/5.0kg) 50 / 56.2 150 2100 910 63.3 87.2 144 Opaque 1.0mm HB

1.5mm V1
Chemical-resistant
PC/PET 9500CR 1.29 10 (260°C/5.0kg) 53 / 45 150 2270 750 60 79 140 Opaque 2.0mm V0
Ignition-resistant
2.5mm 5VA
MAGNUMTM ABS Resins
Portable device housings: diabetes management equipment,
glucose meters, pumps, insulin pens

8391 MED High Toughness, High Gloss 1.05 8 (230°C/3.8kg) 48 / 35 8.7 2480 230 - 74 99 Opaque 1.5mm HB

5 6
Understanding Your
Material Needs

Trinseo distinguishes itself by taking the time to truly understand our customers’ needs and expectations, and
offering the expertise and knowledge needed for industry-leading, quality focused solutions:

Chemical Resistance Biocompatibility Sterilization

Trinseo has conducted in-house
tests of CALIBRETM PC Reins and
equivalent materials, to evaluate
their reaction to chemicals,
disinfectants, detergents, food
products, cosmetic substances,
oil and grease.
Physical, chemical and
toxicological testing is done
according to ISO 10993 and/or
USP standards to determine the
biocompatibility of various resin
grades and color combinations.
Over the years, we have
collected biocompatibility test
data for a wide variety of our
products.
Selected grades of CALIBRETM
PC Resins and MAGNUMTM ABS
Resins have been specifically
developed to handle a variety
of sterilization processes and
application requirements,
including Steam Autoclaving,
Gamma or Electronic Beam
(e-beam) Radiation and
Ethylene Oxide (EtO).

Quality
Processes

Trinseo produces its medical
grade resins under stringent
quality guidelines, controlled
conditions and validated
processes. Our multiple resin
To accommodate formal Our goal is to provide end-to-
requirements and the need end support to our customers.
for documentation, we offer a
Management of Change process Notification Lot
that includes: of Change Traceability

sources provide an assurance of

Lot Traceability
supply.
Formulation Lock Management
We are committed to providing Notification of Change of
Change
product consistently, predictably Extended Record and Sample
and sustainably. Retention
Extended
Formulation
Record & Sample
Lock
Retention

7
Biocompatibility Testing
Melt Flow Rate
Grade Appearance Biocompatibility Testing
(g/10 min)
Polycarbonate Resins
CALIBRETM 2060 3 Transparent
CALIBRE TM
2061 (All Colors) 6, 15, 22 Transparent / Opaque
CALIBRE TM
MEGARAD TM
2081 6, 15, 22 Transparent
CALIBRE TM
5101 8, 15 Opaque
CALIBRE TM
5201 12 Opaque
PC/ABS Blend
EMERGETM PC/ABS 7700 Advanced Resin 11 Opaque
EMERGETM PC/ABS 7710 Advanced Resin 11 Opaque
EMERGE TM
PC/ABS 7750 & 7760 Advanced Resin 3 Opaque / Custom Color
PC/PET Blend
EMERGETM PC/PET 9100CR Advanced Resin 8.5 Opaque
EMERGE TM
PC/PET 9500CR Advanced Resin 10 Opaque
ABS Resins
MAGNUMTM 8391 MED 8 Opaque

Remarks:
- The above are typical properties only and are not to be construed as specifications; users should confirm results by their own tests.
- Biocompatibility testing has been completed according to ISO 10993 and/or United States Pharmacopoeia (USP) standards.
Limited biocompatibility testing has been completed (ISO 10993 Parts 5 and 10).

Sterilization Techniques
Sterilization Technique

Grade Ethylene Oxide

Steam Autoclave Electron Beam
Gamma Radiation (Eto)
(Cycles) (e-beam) Radiation
(Cycles)
CALIBRETM 2060, 2061 Series
2061 030003 (Transparent) 1-5 Not Recommended Not Recommended 1-5
2061 030004 (Transparent) 1-5 Not Recommended Not Recommended 1-5
2060 030003 1-5 Not Recommended Not Recommended 1-5
2061 (All Colors) 1-5 Opaque Only Opaque Only 1-5
CALIBRETM MEGARADTM 2081 Series
2081 030006 1-5 2.5 Mrad (25 kGy) 2.5 Mrad (25kGy) 1-5
2081 030116 1-5 5.0 Mrad (50 kGy) 5.0 Mrad (50 kGy) 1-5
2081 030105 1-5 7.5 Mrad (75 kGy) 7.5 Mrad (75 kGy) 1-5
CALIBRETM MEGARADTM 2091 Series
2091 030006 1-5 2.5 Mrad (25 kGy) 2.5 Mrad (25 kGy) 1-5
2091 030105 1-5 7.5 Mrad (75 kGy) 7.5 Mrad (75 kGy) 1-5
MAGNUMTM ABS Series
8391 MED Not Recommended 10 Mrad (100 kGy) 10 Mrad (100 kGy) 1-3

8
R & D, Quality &
Customer Service
Support
Trinseo’s Research & Development and testing
laboratories for our plastics business are strategically
located across North America, Europe and Asia
Pacific. Our technical experts continuously work with
our customers to understand ongoing requirements
and ensure continuous improvement and innovation
throughout our relationships.
All of our manufacturing facilities adhere to disciplined
quality processes to provide material consistently and
reliably, according to specification. In addition, our
management system integrates the key elements
of several external standards into its best practices,
including ISO-9001 and 1400.
No matter where you are, our global customer service
representatives are within reach. You can get immediate
assistance through our customer service hotline for
issues ranging from a general question about our
product offerings to a request for a technical data sheet
to a specific handling procedure for a particular product.
9
Sustainability &
Corporate Social
Responsibility
Trinseo is committed to managing its products in
a safe and sustainable manner and we encourage
our suppliers and customers to join our efforts to
collaborate, innovate, and elevate industrial practices
and expectations so that chemical products are
managed safely throughout their lifecycle.
Trinseo has a robust Ethics and Compliance program
and is a Responsible Care® company. As a signatory
to the Responsible Care Guiding Principles, we are
committed to continuously improving our company’s
performance related to health, safety, and the
environment, and to communicate with stakeholders
about our products and processes.
For more information about our sustainability
achievements, please visit our website at
www.trinseo.com/sustainability
10

The principles of Responsible Care® and Sustainable
Development influence the production of printed
literature for Trinseo S.A. and its affiliated companies. As a
contribution towards the protection of our environments,
Trinseo’s printed literature is produced in small quantities
and on paper containing recovered/post-consumer fiber
and using 100 percent soy-based ink whenever possible.
PRODUCT STEWARDSHIP
Trinseo and its affiliated companies have a fundamental
concern for all who make, distribute, and use their products
and for the environment in which we live. This concern is
the basis for our Product Stewardship philosophy by which
we assess the safety, health, and environmental information
on our products so that appropriate steps may be taken to
protect employee and public health and our environment.
The success of our product stewardship program rests with
each and every individual involved with Trinseo products –
from the initial concept and research, to manufacture, use,
sale, disposal, and recycle of each product.
CUSTOMER NOTICE
Customers are responsible for reviewing their
manufacturing processes and their applications of
Trinseo products from the standpoint of human health
and environmental quality to ensure that Trinseo
products are not used in ways for which they are not
suitable. Trinseo personnel are available to answer
questions and to provide reasonable technical support.
Trinseo product literature, including safety data sheets,
should be consulted prior to the use of Trinseo products.
Current safety data sheets are available from Trinseo.
No freedom from infringement of any patent owned by
Trinseo or others is to be inferred. Because use conditions
and applicable laws may differ from one location to another
and may change with time, the customer is responsible
for determining whether products and the information
in this document are appropriate for the customer’s use
and for ensuring that the customer’s workplace and
disposal practices are in compliance with applicable legal
requirements. Although the information herein is provided
in good faith and was believed to be accurate when
prepared, Trinseo assumes no obligation or liability for the
information in this document.
NOTICE REGARDING MEDICAL APPLICATION RESTRICTIONS
Trinseo requests that customers refer to Trinseo’s Medical
Application Policy before considering the use of Trinseo
products in medical applications. The restrictions and
disclaimers set forth in that policy are incorporated
reference.
Refer to the full medical application policy.
DISCLAIMER
TRINSEO MAKES NO WARRANTIES, EITHER EXPRESS OR
IMPLIED, IN THIS DOCUMENT; ALL IMPLIED WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE (INCLUDING MEDICAL APPLICATIONS) ARE
EXPRESSLY EXCLUDED. TRINSEO DISCLAIMS ANY AND ALL
LIABILITY FOR LOSSES OR DAMAGES THAT MAY RESULT
FROM THE USE OF TRINSEO PRODUCTS IN UNSUPPORTED
For more information on products, innovations,
expertise, and other services available from
Trinseo, visit www.trinseo.com, or contact us
as indicated below.
North America
U.S. +1-855-TRINSEO (+1-855-874-6736)
U.S. & Canada +1-989-633-1718
Latin America
Brazil +55-11-5184-8722
Argentina, Chile, South Region of LAA +54-11-4319-0100
Mexico, Colombia, North Region of LAA +52-55-5201-4700
Europe/Middle East/Africa +800-444-11-444
+31-11567-2601
Asia Pacific +603-7965-53-19
China +86-21-3851-1017
Email CIG@trinseo.com
www.trinseo.com
MEDICAL APPLICATIONS. TRINSEO MAKES NO
WARRANTIES, EXPRESS OR IMPLIED, THAT THE USE
OF ANY TRINSEO PRODUCT WILL BE FREE FROM ANY
INFRINGEMENT CLAIMS.
GENERAL NOTICE
Any photographs of end-use applications in this document
represent potential end-use applications but do not
necessarily represent current commercial applications, nor
do they represent an endorsement by Trinseo of the actual
products. Further, these photographs are for illustration
purposes only and do not reflect either an endorsement
or sponsorship of any other manufacturer for a specific
potential end-use product or application, or for Trinseo, or
for specific products manufactured by Trinseo.
If products are described as “experimental” or
“developmental”: (1) product specifications may not be
fully determined; (2) analysis of hazards and caution
in handling and use are required; (3) there is greater
potential for Trinseo to change specifications and/or
discontinue production, and (4) although Trinseo may from
time to time provide samples of such products, Trinseo is
not obligated to supply or otherwise commercialize such
products for any use or application whatsoever.
For additional information not covered by the content of
this document or to ensure you have the latest version
of this document available, please refer to the Customer
Information Group contact information on our website at
www.trinseo.com/contact/.
Copyright© Trinseo (2015) All rights reserved.
™Trademark of Trinseo S.A. or its affiliates
®Responsible Care is a service mark of the American Chemistry Council
Form No. 857-07701