EN ISO 23445:2021 - Dentistry - Tissue punches (overview)
EN ISO 23445:2021 specifies requirements and test methods for tissue punches used with a handpiece in dentistry, primarily for oral surgical implant procedures (cutting holes/notches in and removing gingival tissue). The standard covers design classification, material selection, dimensional tolerances, mechanical performance (hardness, run‑out), resistance to reprocessing, and marking, labelling and instructions for use.
Key topics and technical requirements
- Scope and use: Applies to tissue punches used with angled dental handpieces for implant-related soft‑tissue removal.
- Classification:
- Type 1 - Hollow (simple hollow punch)
- Type 2 - Centre‑guided (includes centre‑guide feature)
- Materials and surface: Metals shall conform to ISO 21850‑1 (stainless steel materials). Surface finish is at manufacturer’s discretion but must be free of visible surface defects on visual inspection.
- Dimensional tolerances:
- Inner diameter (working part) and centre‑guide diameter: ±0.1 mm of manufacturer’s stated value.
- Length of working part: ±0.5 mm.
- Shank dimensions: conform to ISO 1797.
- Mechanical performance:
- Hardness: ≥ 400 HV2 or ≥41 HRC (tested per ISO 6507‑1 or ISO 6508‑1).
- Run‑out: total indicated run‑out ≤ 0.1 mm (measured with comparator 1 mm from tip).
- Resistance to reprocessing: Subject to reprocessing cycles (default 100 cycles using manufacturer’s cleaning/disinfection/sterilization per ISO 17664). No deterioration, corrosion or loss of marking permitted; hardness and run‑out rechecked after cycles.
- Inspection and test methods: Visual inspection without magnification; dimensional checks per ISO 8325; hardness and run‑out per referenced ISO test methods.
- Marking and labelling: Requirements for device marking, package labelling and user instructions, including declared dimensions and reprocessing information.
Practical applications and intended users
- Manufacturers of dental instruments and tissue punches - for product design, quality control and compliance.
- Dental implant clinicians and surgical teams - to understand instrument specifications and safe reuse limits.
- Regulatory and procurement teams - for specification, conformity assessment and purchasing of compliant devices.
- Test laboratories and quality assurance - to perform dimensional, hardness, run‑out and reprocessing evaluations.
Related standards
EN ISO 23445:2021 is essential for anyone specifying, producing or testing tissue punches used in dental implantology, ensuring consistent safety, performance and reprocessing resilience.
