EN ISO 80601-2-55:2018 PDF

Overview

EN ISO 80601-2-55:2018 (ISO 80601-2-55:2018) defines particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) - medical electrical equipment intended for continuous patient use. The standard covers monitoring of anaesthetic gases, carbon dioxide (CO2) and oxygen (O2) and applies to RGMs that are either stand‑alone devices or integrated into systems (for example anaesthetic workstations or ventilators). It is not applicable to RGMs intended for use with flammable anaesthetic agents.

Key technical topics and requirements

• Scope and intended use: Requirements for continuous operation RGMs used with patients; distinctions when clauses apply to ME equipment only or to ME systems.
• Basic safety and essential performance: Criteria to ensure devices reliably measure and display respiratory gas concentrations and alarm appropriately under normal use.
• Gas-specific monitoring: Particular requirements for anaesthetic gas monitoring, CO2 monitoring, and O2 monitoring.
• Integration and interfaces: Guidance for RGMs integrated into larger medical systems (e.g., signalling, sampling lines, gas inlet/outlet marking).
• Risk management and hazards: Aligns with IEC 60601‑1 risk principles; hazards inherent to physiological function are generally excluded except where IEC 60601‑1 specifies requirements.
• Usability, labeling and marking: Requirements for clear marking (gas inlet/outlet, flow-direction sensitive components), user instructions, calibration and verification procedures.
• Electromagnetic compatibility and environmental testing: Addresses electromagnetic disturbances and certain environmental tests to maintain essential performance.
• Exclusions and regulatory alignment: Notes on non-applicability (flammable agents) and alignment with EU medical device essential requirements (Annex ZA).

Applications and who uses this standard

• Medical device manufacturers designing or updating RGMs and integrated respiratory monitoring modules.
• Clinical engineers and biomedical test laboratories performing product verification, performance testing and acceptance testing.
• Regulatory and quality teams preparing technical documentation for CE marking and conformity with EU directives.
• Procurement and hospital technology management evaluating device compliance and suitability for clinical settings.
• Design teams addressing usability, labeling, alarm testing, sampling interfaces, and system integration.

Related standards (normative references)

ISO 80601-2-55 references and aligns with many standards used in medical electrical equipment development and testing, for example:

• IEC 60601‑1 (and amendments) - general safety for medical electrical equipment
• IEC 60601‑1‑2 - electromagnetic compatibility
• ISO 15223‑1 - medical device symbols
• ISO 80369 series - small-bore connectors
• ISO 17664, ISO 80601‑2‑13 and various IEC/ISO environmental and marking standards

Keywords: ISO 80601-2-55:2018, SIST EN ISO 80601-2-55, respiratory gas monitor, RGM, anaesthetic gas monitoring, CO2 monitoring, O2 monitoring, medical electrical equipment, essential performance, device safety, clinical integration.