ISO 8600-1:2025

Overview

ISO 8600-1:2025 - "Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements" is the fifth edition of the international standard that defines core terminology and general design, safety and performance requirements for medical endoscopes and endotherapy devices. It governs how manufacturers describe device geometry and optics, how devices are marked and documented, and which basic safety, biocompatibility and connector rules apply.

Key topics and technical requirements

• Scope and terminology: Standardizes terms such as insertion portion, instrument channel, maximum insertion portion width, field of view, direction of view and controllable portion. The 2025 edition updates the definition and illustration for field of view.
• Design and surfaces: Devices must be designed to prevent unintentional injury; outer surfaces must be free of pores, cracks and tooling residues.
• Dimensional requirements:
  • Maximum insertion portion width and minimum instrument channel width shall not exceed or be smaller than values stated in the instruction manual.
  • Working length is defined as insertion portion length stated in the manual.
• Optical performance:
  • Field of view deviation from the manufacturer-stated value shall not exceed 15% (unless otherwise specified).
  • Direction of view deviation for rigid endoscopes shall not exceed 10° (unless otherwise specified).
• Deflection control: Requirements for hand-wheel (knob) deflection systems are specified; if a different control layout is used, clear labeling must indicate controller movement versus tip deflection.
• Safety and biocompatibility:
  • Conformity to IEC 60601-2-18 for electrical and basic safety.
  • Materials in contact with patients evaluated per ISO 10993-1 for biological compatibility.
• Connectors and risk management:
  • ISO 80369‑7 connectors are recommended for liquid/gas fittings; if alternate connectors are used, a risk management process (e.g., ISO 14971) must demonstrate acceptable risk.
• Ancillary topics: Testing methods, minimum marking, instruction manuals, packaging and informative Annex A with guidance on connector risk management.

Practical applications and who uses this standard

• Medical device manufacturers - design validation, labeling, user instructions and compliance strategy for endoscopes and endotherapy tools.
• Regulatory and quality teams - technical files, conformity assessment and risk management evidence for market approval.
• Clinical engineers and procurement - device specifications, compatibility checks (connectors, channel sizes, optics) when selecting or integrating equipment.
• Sterilization and maintenance services - guidance on materials and surface requirements affecting cleaning and reprocessing.

Related standards

• ISO 8600-3 (field of view/direction of view testing)
• ISO 8600-4 (maximum insertion width testing)
• ISO 8600-6 (instrument channel and insertion portion terminology)
• ISO 10993-1 (biological evaluation)
• ISO 14971 (risk management)
• IEC 60601-2-18 (endoscopic equipment safety)
• ISO 80369-7 (small-bore connectors for liquids/gases)

For manufacturers and clinical users, ISO 8600-1:2025 is the foundational document to ensure safe, interoperable and clearly specified endoscopic devices.