Requirements for Medical Plastics-Launch of new Guideline

摘要

Safety for patient and user is an essential requirement for medical products.Subsequently,plastics grades used in medical have to fulfil particular requirements,i.e.constant properties,formulation lock or biocompatibility.Surprisingly,no standard has existed to define the requirements for medical grades so far.This gap has been filled recently by the new guideline VDI 2017 developed and launched by a work group of the German Engineer's Society (VDI).This article addresses the development of the new guideline and presents the essential requirements to be covered by a medical grade.