USP Class VI 测试是通过使用不同的提取液（例如聚乙二醇和植物油）制备产品的提取物，并将其注射到体内（活体）标本（兔子和小鼠）中，以观察对提取物的生物反应.

USP Class VI applies to one of the six classifications for plastics from General Chapter 88 of the United States Pharmacopeia and National Formulary (USP-NF). Chapter 88 sets out standards for testing and certification of a material to be utilised in a medical device.

2024年1月19日 · USP Class VI是USP中规定的六个检测级别之一，是所有USP测试中最严格的一个级别。USP Class VI主要用于证明产品不会因从塑料材料中渗出的化学物质引起有害反应或长期身体影响。

Class VI testing is aimed to certify that there are no harmful reactions or long-term bodily effects caused by chemicals that leach out of plastic materials. USP Class Testing standards are determined by the United States Pharmacopeia and National Formulary (USP-NF), the organization responsible for the quality and safety of medical devices and ...

USP Class VI refers to one of the six designations for plastics from General Chapter <88> of the United States Pharmacopeia and National Formulary (USP-NF). This chapter provides guidelines for testing and certification of a material to be used within a medical device.

Brooks Instrument explains USP Class VI standards and ADI-free certification for the materials used in production of elastomers. Its SLA Series Biotech mass flow controllers are available with FDA/USP Class VI and ADI-free O-rings and valve seats for …

To test medical device biocompatibility, manufacturers often use USP procedures such as the USP In Vivo Biological Reactivity Tests (Class I-VI Plastics Tests). The Class Plastics tests consist of various combinations of the USP Intracutaneous Test and the USP Systemic Injection Test, using one or more combinations of four extracting media .

When selecting USP Class VI silicones, consider the ingredients and certifications, colors and curing systems, material tolerances, sizes, and lead times. The durometer, or hardness, of a USP Class VI silicone is also important because it determines the elastomer’s compressibility, which supports sealing.

Plastics and elastomers that meet the guidelines of USP Class VI standard are suitable for implantation into the human body without any complications. Currently, this is the highest requirement to material harmlessness. Relatively new and initialized from the US market is a new qualification of product contacting plastics.

2020年12月9日 · Class VI testing vigorously investigates where there is a reaction in the skin, body and living tissue, ensuring that a product is safe for use. USP Class VI testing helps ensure that all materials used in industrial processes are biocompatible with any substances or chemicals they may encounter.