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- Title
MDR für die Zahntechnik: Die grundlegenden Sicherheits- und Leistungsanforderungen (GruSuLa).
- Authors
STRIETZEL, ROLAND
- Abstract
The article "MDR for dental technology: The basic safety and performance requirements (GruSuLa)" deals with the basic safety and performance requirements for medical devices in dental technology according to the Medical Devices Regulation (MDR). Medical devices must be safe and effective and must not endanger the clinical condition of patients or the safety of users. The handling of the products should be user-friendly and the processing processes simple and manageable. Manufacturers of medical devices must implement a risk management system to identify and reduce risks. The packaging of medical devices must ensure that there is no contamination, mix-up, or damage. The basic safety and performance requirements are described in detail in the annexes of the MDR. The article deals with deviations from safety and performance characteristics when using dental materials. Various examples of such deviations are mentioned, such as the use of undisclosed material combinations or the undersizing of crowns. The article also addresses the basic safety and performance requirements according to the MDR, particularly focusing on three substance groups: CMR substances, phthalates, and nanomaterials. It is emphasized that the use of nanomaterials can potentially be dangerous and that manufacturers must demonstrate that their products do not contain nanomaterials. The requirements for design and manufacturing are listed in a table. The text describes various requirements for medical products. It is emphasized that the quality, safety, and benefits of the products must be verified according to the applicable conformity assessment procedures. Products that are introduced into the human body and absorbed or distributed by the body must meet certain requirements. Products made from biological materials must follow certain provisions for manufacturing and processing. Requirements for products with diagnostic or measuring functions, as well as for protection against radiation and programmable electronic systems, are also described. Finally, requirements for active products and associated products are mentioned. The text describes various requirements for medical products regarding their internal or external power source, monitoring of clinical parameters, reduction of electromagnetic interference, protection against unintended electrical shocks, protection against unauthorized access, protection against mechanical and thermal risks, protection against risks from the release of energy or substances, and protection against risks during use by laypersons. These requirements are intended to ensure that the products are safe and functional. Compliance with these requirements can be demonstrated through testing and documentation in the manufacturer's technical documentation.
- Subjects
MEDICAL equipment design; MEDICAL equipment safety regulations; MEDICAL supplies; DENTAL technology; MEDICAL equipment safety measures; DENTAL equipment; MEDICAL equipment; DENTAL metallurgy; MEDICAL technology; BIOMATERIALS; DENTISTRY; MEDICAL laws
- Publication
Quintessenz der Zahntechnik, 2022, Vol 48, Issue 6, p594
- ISSN
0340-4641
- Publication type
Article