Sterilization Container - Helmut Zepf (85.327.30) - Delynov

What is the Helmut Zepf sterilization container (85.327.30)?

The Helmut Zepf sterilization container, reference 85.327.30, is a Class I medical device designed for the reprocessing of manual instrumentation. Manufactured from medical stainless steel by Helmut Zepf Medizintechnik GmbH, this product is a robust stainless steel sterilization box. Its primary role is to serve as a secure receptacle during the critical phases of cleaning, disinfection, and sterilization. This type of surgical sterilization box is essential for maintaining instrument integrity and ensuring total asepsis before any clinical intervention. It is delivered non-sterile and must undergo a full preparation cycle before its first use.

What are the clinical indications for this device?

This container is indicated for the management of manual dental instruments used during oral surgery, implantology, or periodontology procedures. As a dental autoclave container, it facilitates the organization of technical trays and ensures that instruments are correctly exposed to sterilization agents. The use of this instrument sterilization tray is strictly reserved for qualified healthcare professionals. It allows for the grouping of tools necessary for a specific intervention, thereby reducing direct handling and the risk of accidental needlesticks, while ensuring each instrument is ready for subsequent safe use on the patient.

What are the technical characteristics of this container?

The Helmut Zepf container (85.327.30) is manufactured from high-quality medical stainless steel, a material chosen for its resistance to repeated autoclave cycles and chemical disinfection agents. This autoclave container is designed to withstand thermal and chemical cleaning processes without immediate structural degradation. Due to its design and the materials used, the manufacturer specifies that there is no defined maximum limit for the number of processing cycles achievable, although the user must regularly inspect the device. It is a Class I equipment, compliant with safety requirements for the reprocessing of non-invasive or reusable invasive medical devices.

What are the contraindications for the use of this equipment?

The main contraindication related to the use of this device concerns hypersensitivity to the material components. Metal intolerance in the patient may result from indirect or direct contact with the contained instrumentation if it is made of medical stainless steel. If a hypersensitivity reaction is triggered, the clinical procedure must be immediately stopped and necessary corrective measures applied. Furthermore, it is strictly forbidden to use this product if it shows visible damage such as cracks, breaks, or structural defects. Using damaged or worn products compromises sterilization safety and instrument protection.

What are the maintenance and reprocessing precautions?

All Helmut Zepf products must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to clean each product before exposing it to autoclave heat to remove all organic residue. The user must check for the absence of visible damage and wear, particularly on edges or closing mechanisms. Compatibility with other cleaning and disinfection products must also be verified beforehand. As there is no predefined limit of processing cycles, the service life of the device depends on the rigor of maintenance and systematic inspection by the healthcare professional before each cycle.

Who is the manufacturer and what standards are met?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with manufacturing standards for Class I medical devices. The product meets regulatory requirements for manual dental instruments and their associated sterilization equipment. Each unit is identified by a precise technical reference (85.327.30) ensuring material traceability. As a high-precision aluminum or stainless steel sterilization box, it integrates into the risk management protocol of dental practices, ensuring that disinfection and sterilization steps are performed in a controlled environment compliant with the manufacturer's directives.

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Surgical medical consumables play a decisive role in operative safety.