SIST EN ISO 5360:2016 PDF

Overview

EN ISO 5360:2016 (ISO 5360:2016) - "Anaesthetic vaporizers - Agent-specific filling systems" is a CEN-adopted international standard that specifies requirements, including dimensions, for agent-specific filling systems used with anaesthetic vaporizers. The document covers the functional interfaces between liquid anaesthetic bottles and vaporizers to ensure safe, specific, and leak-minimised connections. The standard does not prescribe construction materials (see Annex A for material recommendations). Because of the unique properties of desflurane, dimensions for that agent are intentionally omitted.

Key topics

• Agent-specific design: Defined configurations and dimensional requirements so only the correct anaesthetic agent connects to a given vaporizer.
• Parts and interfaces: Requirements for bottles, bottle collars, bottle connectors, bottle adaptors, male adaptors and filler receptacles.
• Performance criteria: Tests and limits for filling rate, leakage to atmosphere, and overfilling protection.
• Safety and usability: Colour coding, labelling, marking, instructions for use, and usability considerations to reduce user error.
• Clinical and regulatory elements: Requirements for clinical evaluation and manufacturer information (marking, labelling, instructions).
• Annexes:
  • Annex A - recommendations on materials (informative)
  • Annex B - types of agent-specific filling systems (informative)
  • Annex C - method to determine total leakage into atmosphere during filling (normative)
• Normative reference: ISO 1101 (geometrical tolerancing) is referenced for form and tolerance requirements.

Practical applications

• Manufacturers of anaesthetic vaporizers, liquid anaesthetic bottles, and bottle adaptors use EN ISO 5360:2016 to design agent‑specific connectors that prevent cross‑contamination and accidental use of the wrong agent.
• Medical device designers and quality engineers apply the dimensional and leakage requirements to achieve conformity and safe device interoperability.
• Hospital procurement, biomedical engineers, and clinical safety officers use the standard to verify compatibility, labelling, and safe filling practices.
• Regulators and conformity assessment bodies reference the standard for demonstrating compliance with medical device directives (see informative Annex ZA relating to EU Directive 93/42/EEC).

Related standards

• ISO 1101 - Geometrical product specifications (GPS): tolerancing (normative reference)
• EN ISO 5360:2016 is the European adoption of ISO 5360:2016 and supersedes earlier editions (EN ISO 5360:2012).

Keywords: EN ISO 5360, ISO 5360:2016, anaesthetic vaporizers, agent-specific filling systems, desflurane, medical device standards, filling rate, leakage, bottle adaptor, CEN.