Polyetherimide for medical devices and pharmaceutical applications. Healthcare management of change, biocompatible (ISO 10993 or USP Class VI), food contact compliant. EtO and steam sterilizable.
enhanced flow Polyetherimide, Available 3 color(Black,Amber,Grey,White 8H8D255).
standard flow Polyetherimide,Available 5 color number(Black,Amber 1H1000,7H5D224,8H7D210).
MEDIACL RISK ASSESSMENT:
While biocompatibility tests have not been performed for all of these colors in this resin,SABIC Innovative Plastics has subjected samples of ULTEM resins from typical
production lots of HU1000&HU1010 ("natural") molded within the processing guidelines to certain biocompatibility tests specified by the United States Pharmacopeia (USP) or described by ISO 10993, "Biological Evaluation of Medical Devices", which is the guideline for biocompatibility developed by the International Organization for Standardization (ISO).
The ISO 10993 tests were also consistent with the guidance provided by the US Food and Drug Administration (FDA) regarding use of the ISO10993 standard.
These tests include:
1. Systemic Toxicity test,
2. Intracutaneous Toxicity test,
3. Implantation test,
4. Cytotoxicity test,
5. Hemolysis test,
6. Pyrogenicity test,
7. Sensitization test,
8. Physico-chemical test.
The purpose of these tests is to provide our customers with data to help them determine the suitability of the subject resin, for use as containers or accessories for parenteral preparations.
The samples of ULTEM resins subjected to the ISO 10993 tests passed each of these tests and met the criteria for USP Class VI / ISO 10993.
Although the exact formulations of interest to you may not have been subjected to these tests, we believe that if tested, the results of such tests would yield results similar to those described above.
The basis for this belief is that it seems unlikely that the presence or absence of small amounts of colorants, in a tightly bound form in the inert resin matrix,would cause any change in the results of these tests.
The medical device manufacturer and the drug packager are in the best position to know the details of the intended conditions of use. It is incumbent upon the device
manufacturer or drug packager to carry out the appropriate biocompatibility tests to
assure safety, efficacy, and regulatory compliance.
SABIC Innovative Plastics considers the determination of suitability of ULTEM resin HU1000&HU1010 for a medical device to be the responsibility of the device manufacturer and the drug packager.
SABIC Innovative Plastics does not recommend and will not support the use of any SABIC Innovative Plastics' products in medical devices intended to remain continuously in the human body for longer than 29 days.
Since there is a potential for chemical incompatibility between ULTEM resin HU1000&HU1010
resin and materials used in components comprising the application or present in the enduse environment, it is recommended that appropriate chemical compatibility be
conducted with all components under intended conditions of use and reasonably
To assist in the review of the use of ULTEM resins for medical devices with the
appropriate FDA regulatory personnel, we maintain a Device Master File (MAF-93) with the FDA.
The MAF contains detailed formulation information and test data on certain grades of ULTEM resins. SABIC Innovative Plastics considers this information
proprietary and does not divulge it without a properly executed secrecy agreement. The FDA holds this information in confidence, but with our specific authorization will review it on behalf of a specific company's application or submittal for the purpose of rendering an opinion about the safety and suitability of the proposed usage.
**Any about madical application ULTEM contact e-mail: email@example.com