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This is the free Material Data Center Datasheet of Ultraform® W2320 003 PRO AT - POM - BASF

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Informations produit
Very free-flowing, rapidly solidifying grade for use where processing is extremely difficult but mechanical properties are lower.

Ultraform® PRO offers a comprehensive service package, which supports customers in product development for the medical technology market.

Ultraform® PRO complies with the basic requirements of Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan respectively as specified below. However, the biocompatibility tests were recorded on tests specimens of Ultraform PRO to show compatibility and potential suitability of the material in general. The biocompatibility-tests and the other tests listed below are not part of any continuous production control.

European Pharmacopoeia, Japanese Pharmacopoeia:
The composition of the product complies with the basic requirements of the European Pharmacopoeia 8th Edition, Chap. 3.2.2. "Plastic Containers and Closures for Pharmaceutical Use" and with the basic requirements of the Japanese Pharmacopoeia,16th 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 Ultraform® PRO.

Food Contact: Ultraform® 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, Telefon: 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: POM
Designation according to ISO 29988-POM-K,,M-GNR,5-2
Caractéristiques des transformations/physiquesValeurUnitéNorme du test
ISO Data
Indice de fluidité à chaud en volume, MVR 25 cm³/10min ISO 1133
Température 190 °C -
Charge 2.16 kg -
Retrait au moulage, parallèle 2.0 % ISO 294-4, 2577
Retrait au moulage, perpendiculaire 2.1 % ISO 294-4, 2577
Propriétés mécaniquesValeurUnitéNorme du test
ISO Data
Module en traction 2850 MPa ISO 527
Contrainte d'écoulement 65 MPa ISO 527
Déformation au seuil d'écoulement 8 % ISO 527
Déformation nominale à la rupture 24 % ISO 527
Module de fluage en traction, 1h 2100 MPa ISO 899-1
Module de fluage en traction, 1000h 1350 MPa ISO 899-1
Résistance au choc Charpy, +23°C 190 kJ/m² ISO 179/1eU
Résistance au choc Charpy, -30°C 190 kJ/m² ISO 179/1eU
Résistance au choc Charpy (entaillé), +23°C 4.5 kJ/m² ISO 179/1eA
Résistance au choc Charpy (entaillé), -30°C 4 kJ/m² ISO 179/1eA
Propriétés thermiquesValeurUnitéNorme du test
ISO Data
Température de fusion, 10°C/min 166 °C ISO 11357-1/-3
Température de fléchissement s/chrg, 1.80 MPa 100 °C ISO 75-1/-2
Température de fléchissement s/chrg, 0.45 MPa 156 °C ISO 75-1/-2
Température de ramolliss. Vicat, B 150 °C ISO 306
Coeffic. de dilatation therm. linéique, parallèle 110 E-6/K ISO 11359-1/-2
Inflammabilité ep. nom. 1.5 mm HB class IEC 60695-11-10
Epaisseur de l'éprouvette 1.6 mm -
Yellow Card disponible oui - -
Inflammabilité pr. épaisseur h HB class IEC 60695-11-10
Epaisseur de l'éprouvette 0.8 mm -
Yellow Card disponible oui - -
Aptitude à l'allumage 15 % ISO 4589-1/-2
Propriétés électriquesValeurUnitéNorme du test
ISO Data
Permittivité relative, 100Hz 3.8 - IEC 62631-2-1
Permittivité relative, 1MHz 3.8 - IEC 62631-2-1
Facteur de pertes, 100Hz 10 E-4 IEC 62631-2-1
Facteur de pertes, 1MHz 50 E-4 IEC 62631-2-1
Résistivité transversale 1E11 Ohm*m IEC 62631-3-1
Résistivité superficielle 1E13 Ohm IEC 62631-3-2
Rigidité diélectrique 40 kV/mm IEC 60243-1
Indice de résistance au cheminement 600 - IEC 60112
Propriétés diversesValeurUnitéNorme du test
Absorption d'eau 0.8 % Sim. to ISO 62
Absorption d'humidité 0.2 % Sim. to ISO 62
Masse volumique 1410 kg/m³ ISO 1183
Recommandations pour la transformation Moulage par injectionValeurUnitéNorme du test
Pré-séchage - température 100 °C -
Pré-séchage - temps 3 h -
L'humidité de traitement ≤0.2 % -
Température de la matière fondue 190 - 230 °C -
Température du moule 60 - 120 °C -
Caractéristiques
Transformation
Moulage par injection
Conditionnement
Granulés
Additifs
Agent de démoulage
Certifications
Contact alimentaire, Grade médical, Biocompatibility ISO 10993, USP Class VI approbation, Drug Master File
Applications
Médical
Disponibilité régionale
Autres informations
Moulages par injection
PREPROCESSING
Pre/Post-processing, max. allowed water content: .2 %
Pre/Post-processing, Pre-drying, Temperature: 100 °C
Pre/Post-processing, Pre-drying, Time: 3 h

PROCESSING
injection molding, Melt temperature, range: 190 - 230 °C
injection molding, Melt temperature, recommended: 200 °C
injection molding, Mold temperature, range: 60 - 120 °C
injection molding, Mold temperature, recommended: 90 °C
injection molding, Dwell time, thermoplastics: 10 min

Processing

Usual single-flighted three-section screws with an effective screw length of at least 15 D, better 20 - 23 D are suitable for the injection molding of Ultraform.

Pretreatment

Granules or pellets in original packaging can be processed without any special pretreatment. Granules or pellets which have become moist due to prolonged or incorrect storage (e.g. by formation of condensed water) must be dried in dehumidifying or recirculating air dryers for approx. 3 hours at about 100 - 110 °C. The moisture content should not exceed 0.2 %.


Postprocessing

If parts were produced at a comparatively low mold temperature (e.g. in order to obtain short cycle times) and must not change their geometry in use thermal postprocessing inducing dimensional changes by postcrystallization may be necessary. In such cases parts should be stored in an oven with recirculated air at temperatures of 100 - 130 °C until dimensions don't change significantly any further. The time needed for this has to be determined experimentally.
Conditions générales
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