EN ISO 8836:2020 PDF

Overview

EN ISO 8836:2020 (ISO 8836:2019) specifies dimensions, design and performance requirements for suction catheters for use in the respiratory tract, covering both open and closed suction catheters made of flexible materials. The standard is intended to help manufacturers, clinicians and testing laboratories ensure safe, interoperable suction catheter products. Suction catheters intended for use with flammable anaesthetic agents, lasers or electrosurgical equipment are excluded.

Key topics and technical requirements

• Scope and definitions - clear terminology for patient end, machine end, closed suction catheter, manifold, eye, etc.
• Materials - general requirements for materials used in catheter shafts, sleeves and connectors (biocompatibility and suitability for respiratory use).
• Design requirements
  • Size designation and dimensions to assist clinicians in selecting catheters compatible with tracheal or tracheostomy tubes.
  • Catheter tip and eye (side holes) design considerations.
  • Connectors - requirements for suction catheter connectors; both male and female connector types are addressed (female connector was reinstated in this edition).
  • Closed suction system components - manifold, protective sleeve, suction control device, flushing system and T-piece port requirements.
• Performance requirements
  • Security of construction and attachment tests.
  • Shaft performance (flexibility, strength).
  • Suction control device performance, leakage and resistance to flow testing methods.
  • Conditions for measurement of residual vacuum in closed systems.
• Sterile supply, packaging and labelling - requirements for devices supplied sterile, packaging integrity and manufacturer information, including marking and instructions for use (IFU).
• Normative and informative annexes - test methods, rationale and hazard identification to support risk assessment.

Applications and who uses this standard

• Medical device manufacturers - to design and certify open and closed suction catheters that meet European and international requirements.
• Regulatory and quality teams - for conformity assessment, technical file preparation and compliance with CEN/ISO requirements.
• Clinical engineering / procurement - to select appropriate catheter sizes and closed suction systems for ICUs, anaesthesia and respiratory care.
• Testing laboratories - to perform the normative tests specified (leakage, residual vacuum, security of attachment).
• Healthcare professionals - guidance on device selection and intended use related to airway management.

Related standards

• ISO 5356-1 (Conical connectors)
• ISO 5367 (Breathing sets and connectors)
• ISO 18190 (General requirements for airways and related equipment)
• ISO 18562-1 (Biocompatibility of breathing gas pathways)
• ISO 80369-7 (Small-bore connectors)
• ISO/TR 11991 (Airway management during laser surgery)

Keywords: EN ISO 8836:2020, ISO 8836:2019, suction catheters, open suction catheter, closed suction catheter, respiratory tract, catheter dimensions, catheter connectors, medical device standard.