ISO 20570:2018

Overview

ISO 20570:2018 specifies requirements and test methods for multiple‑use oral surgical scalpel handles used with detachable blades in dental (oral) surgical procedures. The standard covers form, dimensions, materials, surface quality, hardness, reprocessing resistance, fixation security of blades, and requirements for marking, packaging and instructions for reuse. It is essential for manufacturers, testing laboratories, regulatory compliance teams and purchasers of dental surgical instruments.

Key topics and technical requirements

• Scope and classification
  • Applies to scalpel handles used for cutting/removing soft oral tissues.
  • Three types by geometry: Type 1 (straight), Type 2 (angled/coudé), Type 3 (reverse‑angled/contre‑coudé).
• Dimensions and form
  • Maximum overall length: 178 mm.
  • Assembly zone dimensions comply with ISO 7740:1985.
  • Specific queue/shaft lengths:
    • Type 1: per ISO 7740:1985.
    • Type 2: queue length > 4.50 mm.
    • Type 3: queue length > 22.31 cos β (β = specified angle).
  • Angles: α (Type 2) > 0° and ≤ 90°; β (Type 3) > 20° and ≤ 90°.
• Materials and surface
  • Materials must conform to ISO 7153‑1 (surgical instrument metals).
  • Surface must show no visible defects under normal visual inspection (see test 6.2).
• Mechanical and durability requirements
  • Hardness: ≥ 220 HV1 or ≥ 16 HRC (Vickers and Rockwell tests per ISO 6507‑1 and ISO 6508‑1).
  • Reprocessing resistance: no visible deterioration after 100 reprocessing cycles (or the manufacturer’s declared maximum if lower), tested per manufacturer instructions (see ISO 17664).
  • Fixation security: when a blade is fitted there must be no axial, lateral or rotational movement; tested by applying lateral/axial/rotational finger pressure.
• Marking, labelling and instructions
  • Handle must bear a permanent manufacturer/brand name.
  • Packaging must include manufacturer name/address, lot number, type and model reference.
  • Instructions must detail recommended cleaning, disinfection and sterilization (per ISO 17664).

Applications and users

• Manufacturers: product design, material selection, QA and conformity testing.
• Test laboratories: dimensional, hardness, fixation and reprocessing tests.
• Regulatory and procurement: technical specifications, compliance checks and tender requirements.
• Dental clinics and sterile services: guidance on reprocessing, labelling and safe use.

Related standards

• ISO 7740:1985 - detachable blade assembly dimensions
• ISO 7153‑1 - surgical instrument materials (metals)
• ISO 17664 - information for processing medical devices
• ISO 6507‑1 / ISO 6508‑1 - Vickers and Rockwell hardness test methods

Keywords: ISO 20570:2018, oral surgical scalpel handle, dentistry standard, scalpel handle requirements, reprocessing, sterilization, ISO 7740, ISO 7153-1.