Sterilization Container - Helmut Zepf (85.327.20) - Delynov

What is the Helmut Zepf sterilization container (85.327.20)?

The Helmut Zepf sterilization container, referenced under code 85.327.20, is a Class I device designed for the packaging of surgical instruments. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this autoclave container is specifically structured to withstand cleaning, disinfection, and sterilization processes. Its robust design secures manual dental instrumentation throughout the reprocessing chain, ensuring optimal organization within the dental surgery or implantology practice.

What are the clinical indications for this device?

This dental sterilization container is indicated for the management of manual instruments used during oral surgery procedures. Its use is strictly reserved for healthcare professionals. It serves as a physical support to maintain the integrity of instruments during decontamination and autoclaving phases. As a surgical stainless steel box, it meets the requirements for material preparation for extractions, implant placement, or periodontal surgery, ensuring that devices remain protected against damage and visible wear before clinical use.

What are the technical characteristics of this container?

This surgical sterilization container is manufactured from high-quality medical stainless steel. According to data from the manufacturer Helmut Zepf Medizintechnik GmbH, the product is delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and between each patient. Due to its metallic composition and technical design, there is no defined maximum limit for the number of processing cycles achievable, although the user must inspect the device for potential cracks or defects before each use.

What are the contraindications for the use of this equipment?

The main contraindication related to this device concerns metal intolerance. Contact with this medical stainless steel instrument can trigger a hypersensitivity reaction in certain patients. If such a reaction occurs during the procedure, the manufacturer specifies that the intervention must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before any manipulation. Furthermore, it is strictly forbidden to use the product if it shows visible damage such as breaks or defects on the edges.

What are the precautions and maintenance instructions?

Patient and practitioner safety relies on a rigorous reprocessing protocol. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. Before inserting equipment into the autoclave container, a visual check is essential to set aside any damaged or worn products. Compatibility with other sterilization products must also be verified beforehand. Compliance with these complete cleaning steps is critical to maintaining device performance and preventing risks of cross-contamination in a surgical environment.

Who is the manufacturer and what standards are respected?

This device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I medical device, compliant with regulatory requirements for manual dental instruments. The manufacturer emphasizes that its products are intended exclusively for professional use by qualified practitioners. Although the specific CE marking is not detailed in the provided sources, compliance with the rigorous manufacturing protocols of Helmut Zepf ensures traceability and quality adapted to the constraints of modern dental surgery and thermal reprocessing in an autoclave.

State of the art

Surgical medical consumables play a decisive role in operative safety.