ISO 18340:2020

Overview

ISO 18340:2020 - Endoscopes: Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves specifies design, testing and labelling requirements for universally interchangeable and reusable trocar pins, trocar sleeves and endotherapy devices. The standard sets minimum production requirements to ensure compatibility, safety and reliable performance when these components are used with medical endoscopes.

Key topics and technical requirements

• Scope and purpose: Requirements cover design, testing and labelling for trocar assemblies and endotherapy instruments intended to be mutually compatible and reusable.
• Dimensions and compatibility:
  • Defines key dimensional terms: nominal diameter (ND), minimum inner diameter (IDts,min), maximum insertion portion width (OD).
  • Compatibility rule: OD of an endotherapy device must be ≤ IDts,min of the trocar sleeve; OD must not exceed the nominal diameter.
  • Dimensional tolerances (Table 1):
    • If ND < 5 mm → IDts,min ≥ ND + 0.05 mm
    • If ND ≥ 5 mm → IDts,min ≥ ND + 0.10 mm
  • Sheath and length relationships: sheath length shall be longer than the total length (TL) of the trocar sleeve to ensure safe insertion and retraction.
• Device types:
  • Not dismountable and dismountable endotherapy devices - the standard addresses both configurations and their length/working-length implications.
  • Spring-handle (non-jointed) devices - warns about relative movement needed to open branches and reduced maximum opening compared with jointed forceps.
• Materials: Metallic, non‑metallic or hybrid constructions are permitted provided materials meet medical device requirements.
• Marking and labelling: Marking shall comply with ISO 8600-1 (medical endoscopes and endotherapy devices - general requirements).
• Normative references and safety: Uses terminology from ISO 8600-6; biological evaluation referenced in the bibliography (ISO 10993 series).

Applications and who uses ISO 18340

• Medical device manufacturers designing trocar systems, trocar-compatible endotherapy instruments (forceps, graspers, etc.), and suppliers of reusable endoscopic tools.
• Design and R&D teams ensuring interchangeability across product lines and suppliers.
• Quality assurance, regulatory, and compliance teams validating product labelling, testing and dimensional conformity.
• Hospitals, clinical engineering and procurement teams specifying compatible trocar and endotherapy instruments to maintain safe, minimal-incision procedures.

Related standards

• ISO 8600-1 - Endoscopes: General requirements and marking
• ISO 8600-6 - Vocabulary for endoscopes and endotherapy devices
• ISO 10993 (bibliography) - Biological evaluation of medical devices

Keywords: ISO 18340, trocar sleeves, trocar pins, endotherapy devices, reusable, interchangeable, endoscopes, design, testing, labelling, medical device standards.