Ketron® LSG CA30 PEEK

Identification & Functionality

Chemical Family

Polyether Ether Ketone (PEEK)

Fillers Included

Carbon Fiber

Polymer Name

Polyetheretherketone (PEEK)

Technologies

Plastics

Product Families

Plastics — Parts, Shapes & Films

Features & Benefits

Labeling Claims

BSE-free,

Biocompatible,

TSE-free

Materials Features

Biocompatible,

Chemical Resistant,

Creep Resistant,

Dimensional Stability,

Ethylene Oxide Sterilizable,

Excellent Mechanical Strength,

Gamma Sterilizable,

Heat Resistance,

Heat Sterilizable,

High Stiffness,

Life Science Grade,

Plasma Gas Sterilizable,

Steam Sterilizable,

Wear Resistant,

X-Ray Sterilizable

Product Highlights

• Excellent mechanical strength, stiffness, resistance to chemicals and repeated sterilization via all current methods.
• Pre-assessed for biocompatibility on both resin & stock shape (USP VI & ISO 10993) for up to 24 hours contact.
  • Excellent sterilization resistance via steam, dry heat, Ethylene Oxide, plasma, gamma and x-ray
  • Exceptional resistance to heat and chemicals
  • 30% carbon fiber reinforced for exceptional mechanical properties

Applications & Uses

Markets

Consumer Goods

Applications

Consumer Goods — Appliances & Electronics

Plastics & Elastomers End Uses

Adapter,

Grips,

Washer

Plastics & Elastomers Processing Methods

Compression Molding,

Extrusion

Recommended Applications

• Those in which the duration of contact with human body tissue is limited up to 24 hours*.
• Potential applications for this material include nailing target devices, grips, adapters, and washers.

Properties

Color

Black

Flame Rating

UL 94 V0

Physical Form

Plates,

Rods

Odor

Odorless

Insoluble in

Water

Mechanical Properties

	Value	Units	Test Method / Conditions
Tensile Strength ⁶	144.0	MPa	ISO 527-1/-2 ⁷
Tensile Strain (elongation, at break) ⁶	3.5	%	ISO 527-1/-2 ⁷
Tensile Modulus of Elasticity ⁶	9200.0	MPa	ISO 527-1/-2 ⁹
Shear Strength ⁶	103.0	psi	ASTM D732
Compressive Stress (at 1% nominal strain) ⁶	69.0	MPa	ISO 604 ¹⁰
Compressive Stress (at 2% nominal strain) ⁶	125.0	MPa	ISO 604 ¹⁰
Compressive Stress (at 5% nominal strain) ⁶	170.0	MPa	ISO 604 ¹⁰
Compressive Strength ⁶	29000.0	psi	ASTM D695 ¹¹
Charpy Impact Strength - Unnotched ⁶	50.0	kJ/m²	ISO 179-1/1eU
Charpy Impact Strength - Notched ⁶	5.0	kJ/m²	ISO 179-1/1eA
Izod Impact Notched ⁶	1.03	ft.lb./in	ASTM D256
Flexural Strength ⁶	220.0	MPa	ISO 178 ¹²
Flexural Modulus of Elasticity ⁶	1250.0	ksi	ASTM D790
Rockwell M Hardness ⁶ ¹⁴	102.0	—	ISO 2039-2

Typical Properties

	Value	Units	Test Method / Conditions
Thermal Decomposition	min. 400	°C	—
Self Ignition Temperature	595.0	°C	ASTM D 1929
Density	1.4	g/cm³	ISO 1183-1
Specific Gravity	1.41	—	ASTM D792
Water Absorption (after 24h immersion in water of 23 °C)	0.06	%	ASTM D570 ¹⁷
Water Absorption (at saturation in water of 23 °C)	0.35	%	ASTM D570 ¹⁷
Wear Rate	2.0	μm/km	ISO 7148-2 ¹⁸
Dynamic Coefficient of Friction (-)	0.2 - 0.3	—	ISO 7148-2 ¹⁸
Limiting PV (at 100 FPM)	25000.0	ft.lbs/in².min	QTM 55007 ²¹

Thermal Properties

	Value	Units	Test Method / Conditions
Melting Temperature (DSC, at 10°C) ¹	340.0	°C	ISO 11357-1/-3
Thermal Conductivity (at 23°C) ¹	0.92	W/(K.m)	—
Coefficient of Linear Thermal Expansion (at -40 to 150 °C) ¹	10.0	μin./in./°F	ASTM E-831 (TMA)
Coefficient of Linear Thermal Expansion (at 23 to 60°C) ¹	25.0	μm/(m.K)	—
Coefficient of Linear Thermal Expansion (at 23 to 100°C) ¹	25.0	μm/(m.K)	—
Coefficient of Linear Thermal Expansion (above 150°C) ¹	55.0	μm/(m.K)	—
Heat Deflection Temperature (method A, 1.8 MPa) ¹	260.0	°C	ISO 75-1/-2
Continuous Allowable Service Temperature in Air (for 20 hrs) ¹ ³	250.0	°C	—
Service Temperature ¹ ⁴	-20.0	°C	—
Flammability UL 94 (3 mm) ¹ ⁵	V - 0	—	—
Flammability Oxygen Index ¹	40.0	%	ISO 4589-1/-2

Electrical Properties

	Value	Units	Test Method / Conditions
Electric Strength	32.0	Volts/mil	ASTM D149
Volume Resistivity	1 x 10⁴	Ohm.cm	IEC 62631-3-1
Surface Resistivity	1 x 10⁴ to 1 x 10⁶	Ohm/sq.	ANSI/ESD STM 11.11

Note

Handling (Machining) :

• During machining of the semi-finished products, evacuate swarf to prevent slipping or tripping hazard and observe the maximum allowable concentration of dust and
• formaldehyde levels on the workplace which apply in your country.
• Wear safety goggles during machining.

Storage:

• The products shall be stored indoors in a normal environment (air at 10 - 30°C / 30 - 70% RH) and kept away from any source of degradation such as sunlight, UV-lamps, chemicals (direct or indirect contact), ionizing radiation, flames, etc.
• Dimensional changes (camber, warpage, shrinkage …) of the products as well as slight color shifts of the external surfaces can occur with time.
• The latter does generally not pose a problem in case of semi-finished products since the surface-layer is mostly removed anyway upon machining them into finished parts.

Safety measures:

• Standard industrial safety recommendations shall be observed.
• Temperatures above the melting temperature shall be avoided.

Regulatory & Compliance

Certifications & Compliance

ISO 10993,

SARA 302,

SARA 304,

SARA 313,

UL 94,

USP Class VI

Technical Details & Test Data

Material Selection

Biocompatibility Pre-assessment Table - Medical

	1. Cytotoxicity Ref.: ISO 10993-5 and USP <87> Biological Reactivity Tests, In Vitro Elution Test	2. Sensitization Ref. ISO 10993-10, Magnusson & Kligman Maximization Method	3. Intracutaneous Reactivity Ref.: ISO 10993-10 and USP <88> Biological Reactivity Tests, In Vivo – Intracutaneous Test	4. Acute Systemic Toxicity Ref.: ISO 10993-11 and USP <88> Biological Reactivity Tests, In Vivo – Systemic Injection Test	5. Implantation Test Ref.: USP <88> Biological Reactivity Tests, In Vivo – Implantation Test (7 days)	6. Human blood compatibility Ref.: ISO 10993-4, Indirect Hemolysis (in vitro)	7. USP-Physicochemical Tests for Plastics Ref.: USP<661> Containers, Ultra Pure Water extract, 70°C/24h	USP Class VI Conclusion from tests 3, 4 and 5	Intended applications of which the duration of contact with human body tissue is limited to.
Ketron® LSG CA30 PEEK	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	Shape Tested (incl. raw materials)	max. 24h

Biocompatibility Pre-assessment Table - Bioprocessing

	USP Class VI Conclusion from tests 3, 4 and 5	Animal Free Origin (AFO) or EMA/410/01 Rev.3 (Absence of BSE/TSE)	Food Contact – FDA Ref.: USA FDA 21 CFR 177 and 178	Food Contact – EU Ref.: Commission Regulation (EU) No 10/2011
Ketron® LSG CA30 PEEK	Shape Tested (incl. raw materials)	Absence TSE/BSE	Not Compliant	Not Compliant

Sterilization Resistance

	Compatibility with some commonly used sterilization methods
	Ethylene Oxide gas	Wet heat (steam) 121°C / 134°C	Dry heat 160°C	Plasma	Gamma irradiation	X-ray irradiation
Ketron® LSG CA30 PEEK	Very Good	Very Good	Very Good	Very Good	Very Good	Very Good

Chemical Resistance

	Weak (dilute) acids	Strong acids	Oxidising chemicals	Weak (dilute) alkalis	Strong alkalis	Hot water (80°C)	Steam	Esters (e.g. ethyl acetate)	Ketones (e.g. acetone)	Aromatic hydrocarbons (e.g. benzene, toluene)	Aliphatic hydrocarbons (e.g. hexane, octane)
Ketron® LSG CA30 PEEK	Resistant - In general acceptable Service Life	Partially Resistant - Limited Service Life	Partially Resistant - Limited Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life	Resistant - In general acceptable Service Life

X-ray Transparency

Transparency of the life science grades to high energy radiation (Measured at 23°C on 12 mm thick test plates, applying radiation with an energy level of 59keV)

Radiation Resistance

Resistance of the life science grades to gamma radiation

• Index 6 = 106Gy / 1MGy = 106Gy / 1 Gy = 100rad /
• 100rad = 1J/kg / 1J/kg = 6.24.1012MeV/kg
• X-rays energy ranging from 100eV to 100keV. Gamma radiation have energy greater than 100keV.
• The Radiation Index (RI) is defined as the logarith, base 10, of the absorbed dose in Mega grays at which the flexural stress at break or flexural strain at break of the tested material is reduced to 50% of its original value, under specified conditions of irradiation (the most radiation-sensitive of these two properties is chosen as the reference critical property).

Storage & Handling

Storage and Handling Information

Handling (Machining) :

• During machining of the semi-finished products, evacuate swarf to prevent slipping or tripping hazard and observe the maximum allowable concentration of dust and
• formaldehyde levels on the workplace which apply in your country.
• Wear safety goggles during machining.

Storage:

• The products shall be stored indoors in a normal environment (air at 10 - 30°C / 30 - 70% RH) and kept away from any source of degradation such as sunlight, UV-lamps, chemicals (direct or indirect contact), ionising radiation, flames, etc.
• Dimensional changes (camber, warpage, shrinkage …) of the products as well as slight colour shifts of the external surfaces can occur with time.
• The latter does generally not pose a problem in case of semi-finished products since the surface-layer is mostly removed anyway upon machining them into finished parts.

Safety measures:

• Standard industrial safety recommendations shall be observed.
• Temperatures above the melting temperature shall be avoided.