ISO 23445:2021

Overview

ISO 23445:2021 sets the international standard for tissue punches used in dentistry, specifically designed for oral surgical implant procedures. These instruments are used with dental handpieces to cut holes or notches and remove gingival tissue efficiently and safely. This standard specifies detailed requirements for the design, material selection, performance, marking, labelling, and test methods of tissue punches to ensure consistent quality and safety in clinical applications.

Tissue punches play a vital role in dental implant surgeries by enabling precise removal of soft tissue, minimizing trauma and enhancing procedural outcomes. ISO 23445:2021 supports manufacturers and dental professionals by providing clear guidelines for the production and use of these specialized instruments.

Key Topics

• Scope and Application: Defines tissue punches for use with handpieces in dentistry, primarily for implant-related oral surgery.
• Classification: Tissue punches are classified into two types:
  • Type 1: Hollow
  • Type 2: Centre-guided
• Material Selection: Metals must comply with ISO 21850-1, emphasizing corrosion resistance and biocompatibility.
• Surface Finish: Free from visible defects to guarantee instrument reliability.
• Dimensional Requirements:
  • Inner diameter tolerances ±0.1 mm
  • Length tolerance of working part ±0.5 mm
  • Shank dimensions in accordance with ISO 1797
• Performance Criteria:
  • Hardness ≥ 400 HV2 or 41 HRC for durability
  • Run-out (instrument concentricity) ≤ 0.1 mm to ensure precise cutting
  • Resistance to reprocessing including cleaning, disinfection, and sterilization processes with no surface deterioration after up to 100 cycles
• Marking and Labelling:
  • Permanent, legible markings of inner diameter and optional length data on the instrument
  • Package labelling to include diameter and recommended/max speeds
  • Instructions for use must detail reprocessing protocols and operation speeds
• Test Methods: Visual inspection, precise dimensional measurement, hardness testing, run-out evaluation, and reprocessing resistance tests as per referenced ISO procedures.

Applications

ISO 23445:2021 tissue punches are essential in implant dentistry for:

• Creating precise gingival tissue openings during oral surgery
• Enhancing surgical efficiency while minimizing patient discomfort
• Ensuring compatibility with handpieces through stringent size and shank specifications
• Maintaining consistent performance through validated reprocessing and durability requirements

These standards help dental clinics, surgical centers, and manufacturers to guarantee instrument safety, effectiveness, and compliance with regulatory requirements. By adhering to ISO 23445:2021, manufacturers improve product consistency, while clinicians gain confidence in instrument performance during critical implant procedures.

Related Standards

• ISO 21850-1: Materials for dental instruments – Stainless steel requirements for corrosion resistance and strength
• ISO 1797: Shanks for rotary and oscillating dental instruments, ensuring proper fit and operation
• ISO 8325: Test methods for rotary instruments, providing measurement accuracy
• ISO 17664: Guidelines on reprocessing medical devices, crucial for infection control
• ISO 13504: General requirements for dental instruments and accessories
• ISO 1942 and ISO 16443: Terminology standards supporting consistent communication and definitions within dental professions

By following ISO 23445:2021 and its complementary standards, dental professionals and manufacturers ensure that tissue punches meet international quality benchmarks for safety, precision, and longevity-key factors in successful dental implant surgeries and patient outcomes.