Biocompatibility describes a plastic’s ability to safely perform its intended function in contact with the human body without causing unacceptable biological effects. As part of its risk management and incoming raw material inspection processes, Röchling Industrial has representative batches of its semi-finished products tested for cytotoxicity by an accredited institute in accordance with DIN EN ISO 10993-5:2009. The test assesses products manufactured from the specified raw material under representative conditions. Röchling Industrial therefore provides test results according to ISO 10993-5 and/or USP Class VI for all healthcare and medical products.

Our healthcare and medical semi-finished products are manufactured under controlled conditions using carefully selected raw materials covered by supplier no-change agreements. No other plasticizers, recycled, reconstituted, regrind, reclaimed or reprocessed raw materials are used. To reduce internal stress, the products undergo an annealing process after production. The products are annealed to minimize internal stress and ultrasonically inspected to verify that they are free of pores. Mechanical processing, including planing, sawing, and milling, is performed without cooling lubricants.

Our Medical Grade (MG) materials are specially developed for medical devices in risk classes I, IIa, and IIb involving direct contact with body fluids, tissue, or bone for less than 24 hours. They are manufactured under an ISO 13485-certified quality management system, with documented processes, consistent formulations, controlled change management, security of supply, and full traceability to the raw-material batch. Biocompatibility is tested on representative semi-finished products according to ISO 10993-5 and, where applicable, USP Class VI. The materials are intended for short-term medical applications in accordance with the Regulation (EU) 2017/745, so called Medical Device Regulation (MDR) and are not approved for implants, risk-class III devices, or contact lasting more than 24 hours.

DIN EN ISO 10993-5 specifies in vitro cytotoxicity testing, which assesses whether substances released from a material can damage cells, inhibit cell growth, or cause cell death. The test is performed using cultured mammalian cells that are exposed either directly to the test material or to an extract of it.

For our healthcare and medical products, a representative batch of semi-finished products made from each specified raw material is tested by an accredited institute. The result provides evidence of cytotoxicity performance, but it does not by itself constitute a complete biocompatibility assessment for every finished medical device or its intended use.

USP Class VI test results are available upon request for selected products tested at 70 °C for 24 hours. Depending on the material, testing was conducted either by the raw material supplier or directly on semi-finished products manufactured by Röchling Industrial. Product-specific documentation can be provided based on availability.

Medical Grade (MG) materials are specially developed for medical devices and focus on ISO 10993 Type A applications in accordance with the Regulation (EU) 2017/745 involving body contact for less than 24 hours. They are supported by documented processes, product information, consistent quality controls, and a quality management system certified according to DIN EN ISO 13485. 

Healthcare Grade (HG) materials are designed for demanding applications in the healthcare, pharmaceutical, diagnostic, and life-science industries. They offer defined material quality, controlled production conditions, traceability, and product-specific biocompatibility test results according to ISO 10993-5 and/or USP Class VI. However, our HG portfolio is not intended for use in medical devices within the scope of the Medical Device Regulation (MDR).

Do the materials support MDR requirements?

Yes, our Medical Grade (MG) materials support medical-device manufacturers in meeting MDR requirements through controlled production, traceability, change management, consistent formulations, and product-specific biocompatibility test results. The Medical Device Regulation (EU) 2017/745 (MDR) defines the safety, performance, risk-management, documentation, and market-surveillance requirements for medical devices placed on the EU market. However, a material itself is not “MDR-certified”: responsibility for assessing and demonstrating the compliance of the finished medical device remains with the device manufacturer. The MG material documentation can contribute to this assessment, while Healthcare Grade materials are not intended for medical-device applications under the MDR.

Yes, selected Medical Grade and Healthcare Grade materials comply with the applicable U.S. Food and Drug Administration requirements, depending on the specific material. Product-specific documentation based on information from our raw material suppliers is available on our website. We will be happy to help you select the right material and provide the relevant documentation for your application. Please note that FDA compliance relates to the material composition and does not represent FDA approval of the semi-finished product or final medical device. 

Yes, the raw materials used for Röchling Medical Grade and Healthcare Grade products are traceable to the respective supplier batch. Controlled sourcing and documented production processes ensure transparency throughout the supply chain. Only carefully selected virgin raw materials are used, without recycled, reclaimed, reground, or reprocessed material. We are happy to support you when you have further questions.

We are offering a wide range of Medical Grade and Healthcare Grade materials that can withstand common sterilisation processes, including steam, plasma, ethylene oxide sterilisation as well as gamma radiation. As performance varies according to the material, process, temperature, dosage and number of cycles, selected materials have been evaluated through internal and accredited laboratory testing. Many MG and HG materials also provide high resistance to commonly used disinfectants and cleaning agents according to the raw material data available. Our experts will help you identify the most suitable material for your specific application and sterilisation process.