EN ISO 22570:2020 PDF

Overview

EN ISO 22570:2020 (ISO 22570:2020) specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures. The standard defines shapes, dimensions, materials guidance, surface finish, hardness, marking/labeling and reprocessing performance to ensure safety, interchangeability and effective cleaning/sterilization of these hand‑guided dental instruments.

Key topics and technical requirements

• Scope: Applies to spoons (Hemingway design) and bone curettes (Lucas design) for removal of hard and soft tissue in jawbone regions.
• Classification: Four sizes - Type 1 (S), Type 2 (M), Type 3 (L), Type 4 (XL) based on working‑end width.
• Dimensions:
  • Maximum overall length: 173 mm.
  • Hemingway spoons: detailed breadth/length/height per type (e.g., widths 2.0, 2.5, 3.0, 3.5 mm) with tolerances (±0.15 mm for breadth; ±0.2 mm for length/height where applicable).
  • Lucas curettes: specified widths with tolerances (±0.15 mm).
  • Dimensional tolerances referenced to ISO 2768‑1 and GPS per ISO 1101.
• Materials: Manufacturer’s choice provided requirements are met; if stainless steel is used it shall conform to ISO 7153‑1 or ISO 21850‑1.
• Working end and hardness: Working ends are oval (Hemingway) or pear‑shaped (Lucas). Hardness requirement 42–58 HRC, tested per ISO 6508‑1 (Scale C) or Vickers (ISO 6507‑1) with conversion guidance.
• Surface finish: Working ends and shafts must be polished and free from defects/residues; handle surface should facilitate reprocessing.
• Reprocessing resistance: Instruments shall withstand 100 reprocessing cycles (cleaning, disinfection, sterilization) per manufacturer instructions and ISO 17664 without performance loss or corrosion (unless a lower number is declared by the manufacturer).
• Marking and information: Specifies on‑instrument marking, package labeling and instructions for use, consistent with medical device labeling standards.

Applications and users

This standard is intended for:

• Dental instrument manufacturers (design, production, materials selection, QC)
• Sterilization and reprocessing professionals (validation of cleaning/sterilization cycles)
• Regulatory and quality assurance teams ensuring compliance with medical device requirements
• Procurement specialists selecting standardized instruments for clinics and hospitals

EN ISO 22570 supports product consistency, safe reprocessing, and clear labeling-helpful for clinicians, dental surgery teams and device manufacturers.

Related standards (normative references)

Key related standards referenced include ISO 1101, ISO 1942, ISO 2768‑1, ISO 6508‑1, ISO 6507‑1, ISO 7153‑1, ISO 21850‑1, ISO 13504, ISO 15223‑1, ISO 17664. These cover geometrical tolerancing, terminology, hardness testing, materials and reprocessing information.