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This datasheet of Ultradur® B 4520 PRO from BASF is provided by the international plastics database CAMPUS.
CAMPUS is organized by a group of leading international resin producers, who have agreed to test their material according to uniform conditions, based on ISO standards (ISO 10350, ISO 11403), in order to offer comparable data to the market.
You may contact the supplier for more information about this grade.
Ultradur® B 4520 PRO | PBT | BASF
Product Texts
Ultradur® PRO offers a comprehensive service package, which supports customers in product development for the medical technology market.
Ultradur® PRO is in compliance with Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan as specified below. However, the biocompatibility tests were recorded on tests specimens of Ultradur PRO to show compatibility of the material in general. The biocompatibility-tests listed below are not part of any continuous production control.
European Pharmacopoeia, Japanese Pharmacopoeia:
The composition of the product complies with the requirements of the European Pharmacopoeia 7th Edition, Chap. 3.2.2. "Plastic Containers and Closures for Pharmaceutical Use" and with the requirements of the Japanese Pharmacopoeia, 15th Edition, General Information, “17. Plastic Containers for Pharmaceutical Products”.
However, suitability for the end application concerned including observation of given limitations and toxicological thresholds have to be ensured on the final article by the producer.
US Pharmacopoeia: Biological Reactivity Tests, USP Plastic Class VI (USP VI)
ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Test for Cytotoxicity
DMF: A Drug Master File (DMF) has been registered at FDA for Ultradur® PRO.
Food Contact: Ultradur® PRO is in compliance with multiple regional food contact regulations, especially for Europe and United States.
Additional compliances may also be available. Please contact your local representative or the Ultraplaste Infopoint (e-mail: ultraplaste.infopoint@basf.com, telephone: +49 621-60-78780, fax: +49 621-60-78730).
For notice:
However, BASF has not designed or tested its plastics with respect to all of the special requirements related to their use in medical devices (defined in risk classes I to III according to the European and US Medical Device legislation) and pharmaceutical applications. Therefore BASF makes no warranties, express or implied, concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications.
Abbreviated designation according to ISO 1043-1: PBT
CLASSIFICATION ACCORDING TO ISO 7792-1:
Moulding Compound ISO 7792-PBT, MGHLNR, 13-020
Ultradur® PRO is in compliance with Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan as specified below. However, the biocompatibility tests were recorded on tests specimens of Ultradur PRO to show compatibility of the material in general. The biocompatibility-tests listed below are not part of any continuous production control.
European Pharmacopoeia, Japanese Pharmacopoeia:
The composition of the product complies with the requirements of the European Pharmacopoeia 7th Edition, Chap. 3.2.2. "Plastic Containers and Closures for Pharmaceutical Use" and with the requirements of the Japanese Pharmacopoeia, 15th Edition, General Information, “17. Plastic Containers for Pharmaceutical Products”.
However, suitability for the end application concerned including observation of given limitations and toxicological thresholds have to be ensured on the final article by the producer.
US Pharmacopoeia: Biological Reactivity Tests, USP Plastic Class VI (USP VI)
ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Test for Cytotoxicity
DMF: A Drug Master File (DMF) has been registered at FDA for Ultradur® PRO.
Food Contact: Ultradur® PRO is in compliance with multiple regional food contact regulations, especially for Europe and United States.
Additional compliances may also be available. Please contact your local representative or the Ultraplaste Infopoint (e-mail: ultraplaste.infopoint@basf.com, telephone: +49 621-60-78780, fax: +49 621-60-78730).
For notice:
However, BASF has not designed or tested its plastics with respect to all of the special requirements related to their use in medical devices (defined in risk classes I to III according to the European and US Medical Device legislation) and pharmaceutical applications. Therefore BASF makes no warranties, express or implied, concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications.
Abbreviated designation according to ISO 1043-1: PBT
CLASSIFICATION ACCORDING TO ISO 7792-1:
Moulding Compound ISO 7792-PBT, MGHLNR, 13-020
| Rheological properties | Value | Unit | Test Standard |
| Melt volume-flow rate (MVR) | 25 | cm³/10min | ISO 1133 |
| Temperature | 250 | °C | ISO 1133 |
| Load | 2.16 | kg | ISO 1133 |
| Molding shrinkage (parallel) | 2.1 | % | ISO 294-4, 2577 |
| Molding shrinkage (normal) | 2.5 | % | ISO 294-4, 2577 |
| Mechanical properties | Value | Unit | Test Standard |
| Tensile Modulus | 2600 | MPa | ISO 527-1/-2 |
| Yield stress | 60 | MPa | ISO 527-1/-2 |
| Yield strain | 10.8 | % | ISO 527-1/-2 |
| Nominal strain at break | 30 | % | ISO 527-1/-2 |
| Charpy impact strength (+23°C) | 228 | kJ/m² | ISO 179/1eU |
| Charpy impact strength (-30°C) | 140 | kJ/m² | ISO 179/1eU |
| Charpy notched impact strength (+23°C) | 4.5 | kJ/m² | ISO 179/1eA |
| Thermal properties | Value | Unit | Test Standard |
| Temp. of deflection under load (1.80 MPa) | 55 | °C | ISO 75-1/-2 |
| Temp. of deflection under load (0.45 MPa) | 155 | °C | ISO 75-1/-2 |
| Other properties | Value | Unit | Test Standard |
| Density | 1300 | kg/m³ | ISO 1183 |
| Material specific properties | Value | Unit | Test Standard |
| Viscosity number | 120 | cm³/g | ISO 307, 1157, 1628 |
Characteristics
Processing
Injection Molding
Regional Availability
Europe
Other text information
Injection molding
PROCESSING
injection molding, Melt temperature, range: 250 - 270 °C
injection molding, Mold temperature, range: 40 - 70 °C
injection molding, Melt temperature, range: 250 - 270 °C
injection molding, Mold temperature, range: 40 - 70 °C
Disclaimer
The data contained in this publication are based on our current
knowledge and experience. In view of the many factors that may affect
processing and application of our product, these data do not relieve
processors from carrying out their own investigations and tests. Any
descriptions, drawings, photographs, data, proportions, weights etc.
given herein may change without prior information and do not constitute
the agreed contractual quality of the product. It is the responsibility
of the recipient of our products to ensure that any proprietary rights
and existing laws and legislation are observed. NO WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OFMERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS
DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE
PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING
THEINTELLECTUAL PROPERTY RIGHTS OF OTHERS.
In order to check the availability of products please contact us or our
sales agency.
For more information about our products contact your local BASF
representative or
BASF SE
Dept. KS/KC
Fax: 0621-60-49497
e-mail: e-mail
CAMPUS® is a registered trademark of CWFG (Chemie
Wirtschaftsfoerderungsgesellschaft GmbH, Frankfurt)
knowledge and experience. In view of the many factors that may affect
processing and application of our product, these data do not relieve
processors from carrying out their own investigations and tests. Any
descriptions, drawings, photographs, data, proportions, weights etc.
given herein may change without prior information and do not constitute
the agreed contractual quality of the product. It is the responsibility
of the recipient of our products to ensure that any proprietary rights
and existing laws and legislation are observed. NO WARRANTIES OF ANY
KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OFMERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS
DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE
PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING
THEINTELLECTUAL PROPERTY RIGHTS OF OTHERS.
In order to check the availability of products please contact us or our
sales agency.
For more information about our products contact your local BASF
representative or
BASF SE
Dept. KS/KC
Fax: 0621-60-49497
e-mail: e-mail
CAMPUS® is a registered trademark of CWFG (Chemie
Wirtschaftsfoerderungsgesellschaft GmbH, Frankfurt)
The CAMPUS internet database is hosted by M-Base Engineering + Software GmbH.
M-Base Engineering + Software GmbH assumes no liability for the system to be free of errors.
Any decision about the application of materials must be double checked with the producer of this material.
CAMPUS® is a Registered trademark of CWFG mbH, Frankfurt/Main, 1991
CAMPUS® is a Registered trademark of CWFG mbH, Frankfurt/Main, 1991