材料文字说明
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, 13-020PRO提供全面的服务包，支持客户为医疗技术市场开发产品。Ultradur∈PRO符合药典和生物相容性试验在欧洲，美国和日本的规定如下。然而，生物相容性试验记录在Ultradur PRO的测试样品上，以显示材料的相容性。下面列出的生物相容性试验不是任何连续生产控制的一部分。《欧洲药典》、《日本药典》：该产品的组成符合《欧洲药典》第七版第3.2.2章的要求。药品用塑料容器和密封件”，并符合日本药典第15版，一般信息，“17。药品用塑料容器。然而，有关最终应用的适用性，包括观察给定的限制和毒理学阈值，必须由生产者确保在最终产品上。美国药典：生物活性试验，USP塑料六级（USP六级）ISO 10993-5：医疗器械的生物学评价第5部分：细胞毒性试验DMF：药物主文件（DMF）已在FDA注册，用于Ultradur∈PRO。食品接触：Ultradur∈PRO符合多个地区食品接触法规，特别是欧洲和美国。附加的顺应性也可能是可用的。请与当地代表或Ultraplaste Infopoint联系（电子邮件：.plaste.infopoint@basf.com，电话：+49621-60-78780，传真：+49621-60-78730）。注意：但是，BASF没有设计或测试其塑料的所有特殊要求，涉及其在医疗器械（根据欧洲和美国医疗器械立法定义为风险等级I至III）和医药应用中的使用。因此，BASF对任何BASF塑料用于任何医疗设备和医药应用的适用性没有明示或暗示的保证。根据ISO1043-1：PBT的缩写命名
