BS EN ISO 13397-1:1996 - Periodontal curettes, dental scalers and excavators - General requirements
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BS EN ISO 13397-1:1996 is a European standard that specifies general requirements for periodontal curettes, dental scalers, and excavators. These are dental instruments used by dentists and dental hygienists for various purposes in the treatment and maintenance of the oral cavity, particularly in the context of periodontal care and oral hygiene. Here are some key points covered by this standard:
This standard focuses on periodontal curettes, dental scalers, and excavators. It provides general requirements and specifications for these dental instruments.
Materials: The standard specifies the materials from which these instruments should be made. Materials should be chosen to ensure the instruments' durability, ease of cleaning, and resistance to corrosion and staining. Common materials used include stainless steel.
Design and Construction: The standard outlines requirements for the design and construction of these dental instruments. This includes considerations for ergonomics, sharpness of cutting edges, handle design, and overall durability.
Performance: It addresses the performance of the instruments, such as their ability to effectively remove calculus, plaque, and other debris from teeth and gums. Instruments should be designed to minimize tissue damage while effectively performing their intended functions.
Marking and Identification: Requirements for marking and identifying the instruments are included, such as labeling with the manufacturer's name, product information, and any necessary symbols or codes.
Packaging: The standard covers requirements for the packaging of these instruments to ensure their protection during transportation and storage.
Instructions for Use: Manufacturers are required to provide clear and comprehensive instructions for the proper use and care of these instruments.
Quality Assurance: It emphasizes the need for quality control measures in the manufacturing process to ensure that the instruments meet the specified requirements.
Biocompatibility: Considerations for the biocompatibility of the materials used in these instruments are also addressed to ensure that they are safe for use in the oral cavity.
Cleaning and Sterilization: The standard may include guidance on the appropriate methods for cleaning, disinfection, and sterilization of these instruments to prevent cross-contamination and ensure patient safety.
It's important to note that standards like BS EN ISO 13397-1 are developed to ensure the safety and effectiveness of medical and dental devices, and they help establish a common set of requirements that manufacturers must adhere to when producing these instruments. Compliance with such standards is essential to provide quality dental care and protect patient health.
Since this standard was published in 1996, there may have been updates or revisions to it. Dental professionals, manufacturers, and regulatory bodies should refer to the latest version of the standard to ensure compliance with current requirements and best practices in dental instrument manufacturing.
