The Medical Industry and the Pharmaceutical Industry are very relevant to each other. Although both Industries are close to each other, they are completely different. The Pharmaceutical Industry is more about the production of medicines but also about innovating and inventing new medicines. The medical industry is more about healthcare, like a hospital. Two different industries with one clear goal: 'Making people better!'
Because the Medical- and Pharmaceutical industries are concerned with human lives, very high demands are made on the O-rings used in this industry. For this, there are various certificates that the O-rings must have before they are used. The certificates guarantee certain properties that the O-rings have, so that they can be used safely without endangering the people who are being helped. there are several certificates that are used within this industry. the 2 most commonly used are the ISO 10993 and the USP Class VI.
USP Class VI is a certificate for materials used in the medical and pharmaceutical industry. To earn the certificate, the products must first undergo a number of tests in which the biocompatibility is tested against the standards set by the United States Pharmacopeia (USP). Those standards set by USP are also used by the US Food and Drug Administration (FDA). For example, plastics, polymers and elastomers are tested that are used in medical devices and surgical equipment.