Overview
EN ISO 20570:2018 (ISO 20570:2018) specifies requirements and test methods for multiple‑use oral surgical scalpel handles used with detachable blades for cutting or removing soft oral tissues. Published by CEN/ISO for dentistry equipment, the standard covers design classification, dimensional limits, materials, surface finish, resistance to reprocessing (sterilization), hardness, attachment security, and marking/labelling and instructions for use.
Key topics and technical requirements
- Classification: three handle types - Type 1 (straight), Type 2 (angled) and Type 3 (reverse angled) - defined by the relationship of the fitting feature, shank and handle.
- Dimensions:
- Maximum overall length: 178 mm.
- Fitting feature: must comply with ISO 7740:1985 fitting dimensions for detachable blades.
- Shank lengths: specified minimums for angled and reverse‑angled types (Type 2 > 4.50 mm; Type 3 related to angle β).
- Angles: angle α (Type 2) > 0° and ≤ 90°; angle β (Type 3) ≥ 20° and ≤ 90°.
- Materials: metallic materials shall comply with ISO 7153‑1 (surgical instrument metals).
- Surface finish: surfaces shall be free of visible defects under the test method defined in the standard.
- Resistance to reprocessing: instruments must show no visible deterioration after repeated sterilization/processing tests described in the standard.
- Hardness: minimum 220 HV1 (Vickers) or 16 HRC (Rockwell) with testing referenced to ISO 6507‑1 / ISO 6508‑1.
- Security of attachment: blades must remain secure with no unacceptable axial, lateral or rotational movement under defined tests.
- Marking, labelling and instructions: requirements for marking on the handle, package labelling and user instructions (see clause 7), and reference to processing information per ISO 17664.
Applications and intended users
This standard is used by:
- Dental instrument manufacturers (design, production, testing and CE/national conformity).
- Quality and regulatory teams ensuring medical device compliance.
- Sterilization/process engineers and dental clinics verifying reprocessing suitability and safe reuse.
- Procurement and testing laboratories assessing conformity of scalpel handles.
- Standards committees and auditors referencing harmonized requirements across CEN/ISO member countries.
Related standards
EN ISO 20570:2018 provides practical, harmonized requirements for safe, durable, and reprocessable oral surgical scalpel handles used in modern dental surgery and device manufacturing.
