ISO 19490:2017

Overview

ISO 19490:2017 - Dentistry - Sinus membrane elevator specifies requirements and test methods for sinus membrane elevators used during dental implant procedures to lift the sinus floor (sinus floor lifting). The standard covers materials, dimensions, surface condition, hardness, reprocessing resistance, mechanical connection between the active end and handle, and requirements for marking, labelling and the instructions for use. It is intended to ensure safety, performance and traceability of these dental instruments.

Key topics and technical requirements

• Scope and definitions

  • Applies to hand instruments designed to elevate or displace the sinus membrane via lateral (external) or vertical (crestal) approaches.
  • Defines components: active end (tip and shank/neck), tip (portion entering bone/membrane), and handle.

• Classification

  • Type 1: Lateral/vestibular/external approach
  • Type 2: Vertical/crestal/internal approach

• Materials

  • Active end material shall comply with ISO 13504:2012 (requirements for dental implant instruments).
  • Handle material is left to manufacturer discretion.

• Dimensions and ergonomics

  • Overall length is at manufacturer’s discretion; note that lengths >178 mm may create reprocessing/storage difficulties.

• Surface and reprocessing

  • Instruments must be free from visible surface defects on visual inspection.
  • Must withstand 100 reprocessing cycles (cleaning, disinfection, sterilization) as per manufacturer instructions without corrosion or deterioration.

• Hardness

  • Active end hardness: ≥ 480 HV1 (Vickers) or ≥ 48 HRC (Rockwell). Testing per ISO 6507-1 or ISO 6508-1.

• Mechanical integrity

  • Connection between shank and handle must not develop play after mechanical tests:
    • Tensile test: 1 000 N applied for 5 s (per ISO 15087-1 Annex C).
    • Torsion test: 500 N·cm applied for 5 s (per ISO 15087-1 Annex D).

• Marking, labelling and IFU

  • Instrument marking and packaging labelling must follow ISO 13504:2012 requirements.
  • Instructions for use must include detailed reprocessing methods (cleaning, disinfection, sterilization), with reference to ISO 17664 where applicable.

Applications and users

• Primary users: dental instrument manufacturers, regulatory compliance teams, quality managers, and dental clinics purchasing or validating sinus membrane elevators.
• Practical uses:
  • Product design and validation to meet recognized international performance and safety criteria.
  • Supplier selection and incoming inspection for dental practices and dental device distributors.
  • Regulatory submissions and CE/market compliance documentation.

Related standards

• ISO 13504:2012 - general requirements for implantology instruments
• ISO 15087-1 - dental elevators (test methods referenced)
• ISO 6507-1 / ISO 6508-1 - hardness testing (Vickers / Rockwell)
• ISO 17664 - sterilization information for medical devices

Keywords: ISO 19490:2017, sinus membrane elevator, dentistry standard, dental implants, sinus floor lifting, test methods, hardness, reprocessing, marking and labelling.