Dr. Andreas Nixdorf presented on chemical characterization of plastics used in medical products according to ISO 10993 standards. He discussed the normative framework for chemical characterization and analytical methods for identifying extractables and leachables. Key points included sample preparation according to ISO 10993-12, using both exaggerated and accelerated extraction conditions. A variety of analytical techniques were outlined for separation and detection of extractable substances.

1. CHEMICAL CHARACTERIZATION
OF PLASTIC USED IN MEDICAL
PRODUCTS
Dr. Andreas Nixdorf
China Medical Device Association, 2016 annual meeting
SGS - Life Sciences, Germany
Last changes: Jan. 19 2016

2. 2
AGENDA
 Introduction of SGS E&L German team in brief
 Chemical characterization per ISO 10993, the normative framework
 General analytical methods, ISO 10993 part 18
 Extractables & Leachables: Sample preparation, ISO 10993 part 12, Solvents,
analytical techniques
 What influences material chemical profiles?
 Physical and morphological characterization, ISO 10993 part 19
 Factors influencing biocompatibility
 Examples of surface characterization
 Failure analysis of materials

3. 3
AGENDA
 Introduction of SGS E&L German team in brief
 Chemical characterization per ISO 10993, the normative framework
 General analytical methods, ISO 10993 part 18
 Extractables & Leachables: Sample preparation, ISO 10993 part 12, Solvents,
analytical techniques
 What influences material chemical profiles?
 Physical and morphological characterization, ISO 10993 part 19
 Factors influencing biocompatibility
 Examples of surface characterization
 Failure analysis of materials

4. 4
SGS EXTRACTABLES TEAM – TAUNUSSTEIN
(GERMANY)
 We have long term experience
• Increasing regulatory requirements need knowledge about
guidelines and cross-disciplinary skills
• E&L reports are submitted for product registration
• Assessment to satisfy regulatory authorities:
US-FDA and EMA
by following PQRI, BPOG, BPSA, and ISO 10993 recommendations
 We are Extractables Center of Excellence in Taunusstein
• International client network
• Testing performed in cGMP compliant laboratory or ISO accredited laboratories
• Solid basis of trust and high degree of market acceptance
 We are global partner from Risk Assessment to Toxicological Evaluation
• Customized study design
• Expertise in regulatory questions
• Close communication and exchange with our clients
• Professional and efficient project management

5. 5
EXTRACTABLES & LEACHABLES
OUR EXPERIENCE
Container testing
Stability studies
Method
development & validationMedical device testing
Biocompatibility
Toxicological
assessments

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THE NORMATIVE FRAMEWORK OF ISO 10993

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THE NORMATIVE SYSTEM OF ISO 10993
Evaluation Strategy
ISO 10993 Part 1: Evaluation and testing within a risk management process
Biological Testing
Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
Part 4: Selection of tests for interactions with blood
Part 5: Tests for in vitro cytotoxicity
Part 6: Tests for local effects after implantation
Part 10: Tests for irritation and skin sensitization
Part 11: Tests for systemic toxicity
Part 20: Principles and methods for immunotoxicology
testing of medical devices
Others / Administrative
Part 7: Ethylene oxide sterilization residuals
Part 2: Evaluation and testing within a risk
management process
Part 8: Selection and qualification of reference
materials for biological tests (has been
withdrawn by ISO steering committees)
Part 12: Sample preparation and reference
material
Material Characterization
Part 18: Chemical characterization of materials
Part 19: Physico-chemical, morphological and
topographical characterization of
materials
Degradation Products / Toxicological Evaluation
Part 9: Framework for identification and
quantification of potential degradation
products
Part 13: Identification and quantification of
degradation products from polymeric medical
devices
Part 14: Identification and quantification of
degradation products from ceramics
Part 15: Identification and quantification of
degradation products from metals and alloys
Part 16: Toxicokinetic study design for degradation
products and leachables
Part 17: Establishment of allowable limits for
leachable substances

8. 8
WHY CHEMICAL CHARCTERIZATION?
Chemical Characterization, ISO 10993-18 a useful and important
addition:
 Regulatory bodies are increasingly asking for data on the material and
chemical components of devices
 In Vitro and In Vivo biocompatibility studies are not so sensitive and often do
not allow the root cause of “irritation”
 Complements in vivo biocompatibility studies for qualification of materials
selection
 Analytical chemistry studies help to evaluate hazards that are associated with
the device or with the manufacturing process
 Support process control in manufacturing
 Demonstrate equivalency of proposed materials to a clinically established
material

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WHY CHEMICAL CHARCTERIZATION?
Chemical characterization information can be used for:
 As part of an assessment of the overall biological safety (10993-1, 14971)
 Measurement of the level of leachable substances in a medical device in order to
allow the assessment of compliance – allowable limits for safety risk assessment
 Judging equivalence of a proposed material to clinically established material
 Judging equivalence of a final device to a prototype device to check the
relevance of data on the latter to be used to support the assessment of the former
 Screening of potential new materials for suitability in a medical device for a
proposed clinical application
 NOTE: Part 18 does not address identification or quantitation of degradation
products, which is covered in part -9, -13, -14 and -15.

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CHEMICAL CHARCTERIZATION / ISO 10993-18
Materials characterization in 5+2 principal major steps (see also Dr. Stark in
2003)*:
1. Qualitative Information:
 Describe material and its intended purpose within the device. Data may be taken from
suppliers
2. Material equivalence:
 The new material is compared to an existing material that is used in a device with the
same clinical exposure
3. Quantitative data:
 Quantitative data will be needed, if a risk assessment cannot be made purely on
qualitative information
4. Quantitative risk assessment (see also ISO 14971):
 In The quantitative risk assessment of identified chemicals are compared to toxicological
information, rather than to another material
5. Estimate clinical exposure (see also ISO 14155):
 Finally the amount of potentially harmful chemicals, the dose, is compared to the clinical
dose a patient might receive in a lifetime, a procedure, or other unit of time
6. Exposure of Risk Assessment:
 As before, an evaluation for unacceptable toxicological risks shall be carried out
7. Biological evaluation Tests:
 Where the evaluation indicates that there are still unacceptable risks then appropriate
biological evaluation tests shall be considered in line with part 1
*Stark NJ, Biocompatibility Testing & Management, Fourth Edition, Clinical Device Group Inc, Chicago, IL (2003).

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CHEMICAL CHARCTERIZATION (1/2) – FLOWCHART
OF RISK MANAGEMENT PROCESS ISO 10993-1*
~
*see FDA; Draft Guidance for Industry 2013, “Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing”.

12. 12
CHEMICAL CHARCTERIZATION (2/2) – FLOWCHART
OF RISK MANAGEMENT PROCESS ISO 10993-1*
*see FDA; Draft Guidance for Industry 2013, “Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing”.
~

13. 13
CHEMICAL CHARCTERIZATION / ISO 10993-18
Qualitative and Quantitative information:
 Detailed description of the Material and it´s intended use.
 Materials chemical composition:
 Material constituents (Type of polymer, additives, processing aids, etc.)
 Potential contaminants (unintentionally introduced via material handling)
 The extent to which constituents are subjected to use conditions should be
assessed:
 Perform extraction and migration experiments
 Select analytical methods to give the required information for toxicological
evaluation
 The scope of validation should correspond to the requirements and should become
part of the risk assessment
 Starter materials should also be well characterized
 Information should be provided by suppliers.
 Used to identify toxic hazards arising from the chemical components of materials
 Includes: technical data, specifications, certifications, literature data

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CHEMICAL CHARCTERIZATION (1/3) –ANALYTICAL
METHODS ISO 10993-18 AND OTHERS
General physico-chemical testing:
Analytical Technique Description Application
Dynamic mechanical thermal analysis
(DMTA)
Allows the material response to stress,
temperature, frequency and other values
to be studied
Changes in elastomers by dimension,
changes in stiffness and damping
Differential scanning calorimetry (DSC) Measures the heat capacity of a sample
by comparing the energy required to
change temperature compared wit
reference sample.
Characterization of polymers, change of
transitions and phase changes
Electron dispersal – X ray analysis-
Scanning electron microscopy (EDX-
SEM)
Electron microscopy combined with
elemental and compound analysis using
energetic electrons to liberate X rays for
analysis
Identification of materials in surfaces and
contaminants present. Useful for metals
and ceramics. Verification of deposition of
coatings
Three Dimensional Scanning Electron
Microscopy (3DSEM )
Combines the high resolution imaging of
SEM with quantitative surface metrology
information
Information about the sample's surface
topography and composition
X-ray photoelectron spectroscopy (XPS) Surface analysis by measuring energy of
electrons released by incident radiation.
Examination of surfaces for cleanness,
contaminants and coatings
X-ray fluorescence (XRF) Similar to XPS but delivered energy
results in secondary fluorescence.
Examination of surfaces for cleanness,
contaminants and coatings
Infra red spectroscopy (IR) Measures intra red transmission through
a thin film, or reflectance from a surface
Polymer identification and verification,
identification of particles

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CHEMICAL CHARCTERIZATION (2/3) –ANALYTICAL
METHODS ISO 10993-18 AND OTHERS
General physico-chemical testing :
Analytical Technique Description Application
Secondary ion mass spectrometry
(SIMS-ToF, static and dynamic)
Used to analyze the composition of
solid surfaces by sputtering the surface
of the specimen with a focused primary
ion beam and collecting and analyzing
ejected secondary ions
Elemental composition of materials from the
surface to depths of 100 microns and
beyond. SIMS is generally considered to be
a qualitative, very sensitive technique
White Light Interferometry (WLI) Makes use of the wave superposition
principle to combine waves in a way
that will cause the result of their
combination to extract information from
those instantaneous wave fronts
Topographical information from the surface
including 2D, 3D images and profilometry as
well as roughness parameters including
surface roughness, peak height and valley
depth
Atomic Force Microscopy (AFM) Arguably the most versatile and
powerful microscopy technology for
studying samples where an extremely
sharp inert tip is scanned over a surface
Images in three-dimensional topography, it
also provides various types of surface
measurements. Can generate images at
atomic resolution with angstrom scale
Inductively charge plasma (ICP)
combined with MS or OES
Measures the masses of the element
ions (MS) or the light emitted at
element-specific characteristic
wavelengths (OES) from thermally
excited analyte ions generated by the
high temperature argon plasma
Detection of trace metals in extracts

16. 16
CHEMICAL CHARCTERIZATION (3/3) –ANALYTICAL
METHODS ISO 10993-18 AND OTHERS
General physico-chemical testing :
Analytical Technique
(Chromatography)
Description Application
Mass spectrometry combined with
different ion sources
Identification of compounds by measuring
mass to charge ratios of ions
Elemental composition, identification of
chemical structure, quantitation of substances
Ultraviolet spectroscopy (UV) Absorption of light Analysis of extractions for organic substances
(Leachables) and others
Electrochemical detection (ECD) Amperometric electrochemical detection
the electrical current is measured
resulting from oxidation or reduction
reactions.
Electrochemically active substances
Gel permeation chromatography (GPC) Separation of polymers by transit time
through a gel by size.
Distribution of polymers of different chain
length. GPC is often used to determine the
relative molecular weight of polymer samples
as well as the distribution of molecular
weights
High performance liquid chromatography
(HPLC)
Liquid phase separation and quantitation
of chemical mixtures
Analysis of extractions for organic substances
(Leachables) or cation and anions
Gas chromatography (GC) Separation and quantitation of volatile
substances
Analysis of extractions for organic substances
(Leachables)
Nuclear magnetic resonance (NMR) Detailed analysis structure of complex
molecules by energy measurement of
nuclear environment
Structural analysis of molecules

17. 17
CHEMEICAL CHARACTERIZAION – SAMPLE
PREPARATION ISO 10993 -12 (E&L)
Some important definitions:
 Extractables: Soluble substances that are removed from a device using
exaggerated conditions
 Leachables: Soluble substances that are removed from a device using
conditions of simulated use
 Exaggerated extraction (e.g. by solvent): ..results in a greater amount of a
chemical constituent being released (for identification) as compared to the
amount generated under simulated use conditions
 Accelerated extraction (e.g. by temperature): “…using conditions that
shorten the time for leaching of the substances into the extraction vehicle…”

18. 18
CHEMEICAL CHARACTERIZAION – SAMPLE
PREPARATION ISO 10993 -12 (E&L)
Extraction conditions (justify the selection):
(37 ±1)°C for (72 ±2)h
(50 ±2)°C for (72 ±2)h
(70 ±2)°C for (24 ±2)h
(121 ±2)°C for (1 ±0.1)h
 Other conditions may be used but shall be described and justfied.
 Complete dissolution of material may be appropriate (e.g. Oxidative
digestion of polymer to determine total amount of metals by ICP-MS)

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CHEMEICAL CHARACTERIZAION – SAMPLE
PREPARATION ISO 10993 -12 (E&L)

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CHEMEICAL CHARACTERIZAION – SOLVENTS
ISO 10993 -12 (E&L)
 Soft solvents:
 Polar  Water, Saline, Culture media (no serum)
 Non-polar vegetable oil (may be replaced by pure solvents such as octane,
hexane,…)
 Additional extraction vehicles  ethanol/water, ethanol/saline, PEG 400, DMSO
and culture medium with serum
 Harsh conditions could damage material, avoid it´s dissolution!
 Do extraction under circulation or agitation!
 Maximize the amount of extractables
 Do the extraction with treated (e.g. sterilization) material, if included in your
material process.

21. 21
CHOOSE APPROPRIATE TOOLS FOR
SEPARATION & DETECTION
 Volatiles organics by GC
 Head-space technique, TDMS, FID and MS –detector
 Semi-Volatiles organics by liquid injection GC
 FID and MS detector
 Non-Volatiles organics by HPLC
 DAD, LC-MS/(MS) with accurate mass assignments
 Metals / Elements
 ICP-MS, ICP-OES
 Cations, Anions
 Ion chromatography
 Special Techniques for critical compounds
 GC-TEA for Nitrosamines
 Perfluorinated Carboxylic acids, -Amides, -Sulfonamides by LC-MS/MS
 NMR- Technology, IR and others

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 Identification Categories
 Establish a classification scheme that characterizes the significance of peak
identification data (tentative, confident, confirmed and unknown)
 Best identification means the comparison of both the retention index and the
mass spectrum of an extracted component with its authentic reference
standard
Identificatio
n category
Identification Data
A Interpretation of mass spectrometric
fragmentation behavior or component could be
grouped to a series
B Confirmation of molecular weight
C Confirmation of elemental composition (not
conducted in this study)
D Mass spectrum matches automated library or
literature spectrum
E Chromatographic retention index match
authentic specimen
F Mass spectrum and chromatographic retention
index match authentic specimen
X No characterization possible
Attribute Description
Confirmed A Confirmed identification means that identification
categories A, B (or C), and D (or E or F) have been
fulfilled
Confident A Confident identification means that sufficient data to
preclude all but the most closely related structures
have been obtained, Library match factor ≥ 90
Tentative A Tentative identification means that data have been
obtained that are consistent with a class of molecule
only
unknown No sufficient information’s could be obtained
WHAT IS A TRUSTABLE IDENTIFICATION?

23. 23
WHAT INFLUENCES A
MATERIAL’S CHEMICAL PROFILE?
Some major processing impacts (to be considered in assessment)
 Defects and changes can be caused by incompatible resistance due
to:
 Short and long term exposure to:
 Chemicals
 Irradiation such as UV, e-Beam and Gamma
 Ozone, Oxygen, Ethylene oxide (ISO 10993-7)
 Moisture
 Biological (see ISO 10993 framework)
 Temperature

24. 24
INFLUENCES ON MATERIAL CHEMICAL PROFILE –
EXAMPLE RADIATION RESISTANCE
Gamma Radiation
 Sterility means that a product is free from microorganisms capable of
reproduction
 EN ISO 11137 regulates the sterilization of health care products by
radiation: the manufacture and sterilization of a medical product labeled as
‘sterile’ has to take place under appropriate conditions
 Both the manufacturing process and the subsequent sterilization process
have to be validated (biodurden)
 No validation regarding changes in polymer structure and chemical profile is
considered by EN ISO 11137.

25. 25
INFLUENCES ON MATERIAL CHEMICAL PROFILE –
EXAMPLE RADIATION RESISTANCE
Acrylonitrile butadiene styrene (ABS),
Literature: “Radiation Chemistry of Polymers”, V.S. Ivanov, VSP 1992; “Radiation resistance of polymer materials”, Atomic Energy, Vol. 76, No. 5, pp. 422–428, May, 1994; “A
review of radiation resistance for plastic and elastomeric materials”, Radiation Physics and Chemistry (1977), Volume 24, Issues 5-6, 1984, Pages 503-510

26. 26
INFLUENCES ON MATERIAL CHEMICAL PROFILE –
EXAMPLE RADIATION RESISTANCE
 Carbonic acids: C1, C2, C3 etc.
 C2 – C5 -Aldehydes
 Ketones
 BHT derived from Irganox 1010,
1076
 2,5-di-tert-butyl benzene and
2,5-di-tert- butyl phenol from
Irgafos 168

Gamma 20-
25/45 kGy
BHT: 3,5-di-tert-butyl-4-hydroxytoluol
Oxidation of free radicals:
The energy-rich beta or gamma rays trigger chemical reactions in the plastics
which result in networking or ‘cross-linking’ of the polymer molecules.
Demertzis, P.G.; Franz, R.; Welle, F.; „The Effects of Gamma-Irradiation on Compositional Changes in Plastic Packaging Films”, Packaging
Technology and Science 12 (1999), S.119-130.

27. 27
INFLUENCES ON MATERIAL CHEMICAL PROFILE –
EXAMPLE RADIATION RESISTANCE
Validation of radiation regarding impact on extraction level was missed!
Dose: approx. 32 kGy
Extraction of Pt cured silicone tube at 50 °C for 24 h with WFI
Analyte Blank µg/mL µg/cm2 Compared to Blank
(LOQ) an increase by
factor of
Formaldehyde < LOQ1 21 7 233
Formiate < LOQ2 106 34 25
Acetate < LOQ2 18 14 9
1 0.03 µg/cm2
2 1.6 µg/cm2

28. 28
PHYSICOCHEMICAL, MECHANICAL, MORPHOLOGICAL AND
TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS –
ISO 109993-19
Parameters to be Analyzed are depend on the clinical exposure/application
of the device:
 Porosity
 Morphology: crystallinity of polymer, amorphous, transition phases, hardness
 Surface energy / charge: protein absorption/repulsion, cell attachment etc.
 Abrasion resistance, stability of treated surface
 Topography: surface chemical mapping, roughness
 Particles and release of it: Size, shape, distribution

29. 29
FACTORS INFLUENCING BIOCOMPATIBILITY –
WETTING OF SURFACES
 Wetting is an important phenomenon in many industrial processes, it
has a strong influence on cell growth around implants
 Wetting is dependent on both chemical composition and morphology of
the surface
 Wetability can be studied by measuring the contact angle of the
substrate with the given liquid
Surface roughness measurements, see ISO 25178 and related normative frame work.

30. 30
Grinding pattern  Titanium implant
SURFACE CHARACTERIZATION
REM-EDX – Surface section
Implantat: Hip joint

31. 31
Application: Surface characterization of medical stents
Problem: Determination of Surface Elemental composition ,100 nm layer depth
Method: AES (Auger Electron Spectroscopy)
Result: The stent is made from alloyed steel with a layer thickness of 22 nm
AES-Tiefenprofil, Stent D1
0
20
40
60
80
100
4 6 8 10 12 14
Sputterzeit [min]
Atomkonzentration[%]
C
O
Fe
Cr
Ni
Mo
Removal of surface
contamination by sputtering.
SURFACE CHARACTERIZATION OF MEDICAL
PRODUCT

32. 32
 Product failures are most costly at the pharmaceutical end-user side
 Materials safety and robustness should be considered in any risk assessment
 Product failures causes:
 Recalls or delays in drug product registration
 Warranty claims
 Costs for independent failure analysis
 Brand damage
The best strategy is to avoid failures:
 Qualify your supplier and starter materials quality
 Start to qualify your process at the early stage of product development
 Generally problems do not solve themselves – usually the situation gets worse
 Identify ways to improve or avoid failure in current and future parts
 Advance the knowledge related to materials, design, production methods,
installation techniques, and testing methods
FAILURE ANALYSIS – WHY IS A FAILURE
ANALYSIS IMPORTANT?

33. 33
MATERIAL ANALYSIS - DO YOU KNOW ALL OF
THESE TECHNIQUES?
 Materialography, Light Microscopy
 Electron Microscopy (REM, SEM)
 Atomic-force microscopy (AFM)
 X-ray diffraction (XRD; XRT)
 Electron Probe Microanalyzer (ESMA)
 Photoelectron Spectrometry (XPS)
 Auger Electron Spectroscopy (AES)
 Spreading Resistance Profiling (SRP)
 Secondary Ion Mass spectrometry (SIMS)
 Infrared Spectroscopy (IR),
 Thermoanalysis (DTA, DSC)
 Liquid Chromatography (HPLC, IC)
 Gas Chromatography (GC-MS, HID, TEA, FID, ECD
 Particle analysisD-SIMS Cameca ims 7f
XPS Quantum 2000
ICS 3000

34. 34
STEPS FOR PERFORMING FAILURE ANALYSIS
(PLASTICS)
Obtain Part History
Macroscopic Examination
Microscopic Examination
• Stereomicroscopy
•Scanning Electron Microscopy
•Cross Section
Material Analysis
Composition
•FT-IR
•Energy Dispersive X-ray
•Thermo Gravimetric Analysis
Molecular Structure
•Differential Scanning Calorimetry
•Molecular Weight Evaluation
Physicochemical Analysis
•Dynamic Mechanical Analysis
•Mechanical testing
•Hardness
Determine Failure Mode and
Cause
Determine Contribution
Factors

35. 35
Embedded
Bubbles
The needle was inadequately glued in Luer-lock connector.
There is a high risk for leakage and particle formation.
The glue does not fill the whole space between
connector and needle.
Cracking
FAILURE ANALYSIS – SYRINGE NEEDLE

36. 36
 Observation of Calcium phosphate crystals in finished drug:
 Route cause: Ca2+ ions are leached out from Rubber stopper
forming Calcium phosphate precipitation due to incompatibility to
drug formula.
 Calcium/Octa phosphate Ca3(PO4)2 / Ca4(PO4)3 3·H2O pKsp 28.9
/ 46.9**
 Calcium phosphate are less soluble in neutral and alkaline
conditions and dissolve in acid.
*see: Institute of Validation Technology, published on IVT Network; Alan M. Mancini , Joanne Wong Paul L. Pluta, Ph.D., Compliance Case Study #11 ;
„Glass Fragments in a Parenteral Product , Aug 29, 2014.
** S. Kubo, T. Takahashi, H. Morinaga, and H. Ueki, “Inhibition of Calcium Phosphate Scale on Heat Exchanger: The Relation between Laboratory Test Results
and Tests on Heat Transfer Surfaces”, Corrosion’79, Paper No. 220, Atlanta (1979)
ROUTE CAUSE ANALYSIS – RUBBER
INCOMPATIBILITY TO DRUG FORMULA*

37. 37
PRACTICAL INFORMATION DERIVED FROM
POLYMER ANALYSIS METHODS

38. 38
LIFE INSPIRED (Medical Devices)
THANK YOU FOR YOUR ATTENTION
Dr. Andreas Nixdorf
Business Development/Senior Scientist QC
Life Science Services
SGS Germany
( phone: +49 6128 744-372
2 fax +49 6128 744-700
- e-mail : andreas.nixdorf@sgs.com
Cheney Lin 林春鑫
Agriculture, Food and Life (AFL)
SGS-CSTC Standards Technical Services Co., Ltd.
LSS Dept., 7/F, 3rd Bldg, No.889, Yishan Road, Xuhui District,
Shanghai China, 200233
上海市徐汇区宜山路889号3号楼7层
( phone: +86 (021) 6064 5136
2 fax +86 (021) 6495 1517
- e-mail : cheney.lin@sgs.com

39. 39
LIFE INSPIRED (Failure Analysis)
THANK YOU FOR YOUR ATTENTION
Gerald Dallmann
Division Manager
Consumer and Retail Microelectronics
SGS Germany
( phone: + 49 351 8841 100
2 fax +49 351 8841 190
- e-mail : gerald.dallmann@sgs.com

40. 40
APPENDIX 1 – POYMERS ABBREVIATIONS
ABC: Acrylnitrile butadiene styrene
COC: Cycloolefine Copolymers
FP: Fluorothermoplastic
LCP: Liquid crystal polymers
PA: Polyamide
PBT: Polybutylene therephthalate
PC: Polycarbonate
PE: Polyethylene
PEI: Polyethylenimine
PEEK: Polyetherketone
PES: Polysulfone
PET: Polyethylene therephthalate
PI: Polyimide
PMMA: Polymethylmethacrylate
PMP: Polymethylpentene
PP: Polypropylene
PS: Polystyrene
PPS: Polyphenylene sulfide
PVC: Polyvinychloride
SAN: Styrene acrylonitrile resin
FP: Fluoropolymer
LCP: Liquid Crystal Polymer (unique class of partially
crystalline aromatic polyesters based on p-
hydroxybenzoic acid and related monomers)
PMP: Polymethylpentene
PP: Polypropylene
TPU: Thermoplastic polyurethane
TPA: Poly(trimethylene terephthalate)
TPC: Thermoplastic Copolyester Elastomer
TPV/TPE-V: Elastomeric alloys, sometimes referred to as
thermoplastic rubbers, are a class of copolymers
or a physical mix of polymers (usually a plastic
and a rubber) which consist of materials with
both thermoplastic and elastomeric properties.
TPO: Thermoplastic polyolefin, refers to polymer/filler
blends
TPS: Thermoplastic starch polymer