Which plastics can be safely used in medical technology to manufacture medical and pharmaceutical products or packaging? This and the term “Medical Grade Plastics” are explained in this short article.
Health care is a highly regulated environement. Where glass and metal were used in the past, today plastics have become established. But plastics aren´t always the same. Properties such as biocompatibility, sterilisability, temperature and chemical resistance determine whether or not a plastic is suitable for medical applications.
This is where the term “Medical Grade Plastic” comes into play. And we now explain in detail what medical plastics are.
While “plastic” is a very broad term, “medical grade plastic” refers to a plastic that meets certain basic requirements for use in medicine. The term Medical Grade Plastic is, by the way, defined in the VDI guideline 2017 .
Manufacturers of medical devices can therefore pay attention to the designation “Medical Grade” when selecting materials from the supplier. Also important are the standards ISO 13 485 for quality management, EN ISO 10 993 for biocompatibility of materials and ISO 14 971 (risk management for medical devices).
Conventional plastics such as PE, PC, PP and PVC are among the most commonly used polymers.
Bio-based plastics are increasingly being used in medical technology. Like other industries, the health sector also has to deal with the issue of sustainability. The EU is pushing for the transformation of the European economy towards a fossil-independent circular economy .
Manufacturers are now faced with the challenge of increasing the use of “medical grade bioplastics” or Medical recycled plastics . Because safety is paramount in medicine.
It is a good thing that bioplastics, like their established conventional plastic precursors, have all the necessary properties in this respect: Barrier properties, sterilization capability etc. are no problem when choosing the right bio-material.
"These Medical Grade Bioplastics are for example here with us. The BIOVOX compounds are high quality, sustainable and safe for you, thanks to certified ISO 13 485 quality manager and ISO 10 993 certification of biocompatibility. If you need support when switching to a bio-based material, I will be happy to advise you.“
Plastics have to meet certain safety and quality requirements for use in the medical and pharmaceutical sectors. Manufacturers can use the term “medical grade” to choose the right plastic. Manufacturers will have to pay attention to sustainable materials in the future, because the EU is calling on the healthcare industry to be more sustainable and at the same time deliver safe healthcare.
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