Overview
ISO 9173-1:2016 is an international standard developed by the International Organization for Standardization (ISO) that specifies the general requirements for extraction forceps used in dentistry. These dental instruments, also known as extraction forceps or "daviers," are essential tools in oral surgery for tooth extraction. This standard ensures that extraction forceps meet stringent quality, safety, and performance criteria to support effective and reliable dental procedures.
The 2016 edition replaces the previous 2006 version with updated requirements, particularly focusing on materials, thermal treatment, surface finishing, and resistance to repeated sterilization cycles.
Key Topics
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Materials
Extraction forceps must be made from stainless steel meeting ISO 7153-1 specifications. The components and fixing elements (such as rivets and screws) require thermal treatment to achieve a Rockwell hardness between 40 HRC and 52 HRC, ensuring durability and resistance to wear.
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Dimensions
The maximum total length of forceps must not exceed 200 mm. This size restriction helps ensure comfortable handling and precision during dental procedures.
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Surface Finish
All surfaces must be free of defects and sharp edges to prevent injury and facilitate cleaning. The gripping jaws may have defined striations or serrations, which must be consistently reproducible across models.
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Resistance to Retreatment
The forceps must withstand at least 100 sterilization cycles per manufacturer’s instructions, typically via autoclaving, without corrosion or degradation of mechanical properties. This ensures longevity and safe reuse of dental instruments.
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Joint Mechanics
The articulation must allow smooth opening and closing with an opening/closing torque between 0.20 N·m and 0.68 N·m. The movement of the joint should be stable, with no perceptible lateral displacement to maintain reliability and operator control.
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Marking and Traceability
Each forceps must have indelible markings including manufacturer’s name or brand, model number, lot number, and optionally the ISO 9173 designation for clear identification and quality control.
Applications
ISO 9173-1 extraction forceps are widely used by dental professionals during tooth extractions and oral surgeries. Complying with this standard improves safety and effectiveness in:
- General Dentistry – performing routine extractions with high-quality tools that meet ergonomic and mechanical standards.
- Oral Surgery – specialized forceps designed for particular teeth based on ISO 9173 Parts 2 (Designation) and 3 (Design).
- Dental Clinics and Hospitals – ensuring instruments remain safe and functional after multiple sterilization cycles.
- Manufacturers and Suppliers – guiding production and quality assurance of extraction forceps for international markets.
Related Standards
- ISO 7153-1 – Specifies stainless steel materials suitable for surgical instruments, referenced for material requirements.
- ISO 9173-2: Dentistry - Extraction forceps - Part 2: Designation – Defines the classification and nomenclature of various types of dental extraction forceps.
- ISO 9173-3: Dentistry - Extraction forceps - Part 3: Design – Covers detailed design specifications, including shape and dimensions of forceps specific to tooth type.
- ISO 6508-1 – Describes methods for Rockwell hardness testing applicable to dental instrument materials.
- ISO 17664 – Provides manufacturer instructions for cleaning, disinfection, and sterilization of medical devices, critical for verifying forceps’ retreatment resistance.
ISO 9173-1:2016 establishes the foundation for safe, reliable, and high-performing dental extraction forceps. Adherence to this standard helps dental professionals deliver superior patient care while enabling manufacturers to meet global regulatory requirements.