EN ISO 80601-2-55:2018/A1:2023 PDF

Overview

EN ISO 80601-2-55:2018/A1:2023 is Amendment 1 to the international standard that defines particular requirements for the basic safety and essential performance of respiratory gas monitors (RGMs). Endorsed by CEN and published December 2023, this amendment updates normative references and clarifies technical and usability requirements for medical electrical equipment that measures respiratory gases used in anaesthesia, respiratory care and reanimation.

Key Topics and Requirements

• Updated normative references: The amendment replaces earlier IEC references with their latest amendments (for example IEC 60601-1:2005+A1:2012 is updated to include Amd 2:2020) and updates references to IEC 60601-1-2, -1-6, -1-8, -1-11 and -1-12 where applicable.
• Measurement accuracy and drift: For each respiratory gas an RGM is intended to monitor, the measurement accuracy shall meet the limits in Table 201.102 or better, for not less than 6 h when used with specified gas mixtures. If applicable, measurement drift must be disclosed in the Instructions for Use.
• Test mixtures and response time: The amendment revises Table 201.103 to specify test gas mixtures and concentrations used for drift testing and the total system response time tests (including appropriate end concentrations and notes for agent identification features).
• Calibration / zeroing: Clarifies that certain calibration/zeroing requirements apply only to automatic calibration/zeroing performed by the RGM without operator interaction.
• Patient cross‑infection risk: Adds explicit requirements to the Instructions for Use for RGMs that divert sampled gas and have a gas exhaust connection - manufacturers must include a warning about cross‑infection risk if sampled gas may be returned to the breathing system, unless the manufacturer can demonstrate acceptable risk control. Means of risk control can be part of a host device.
• Usability, EMC and alarm references: Aligns RGM requirements with the latest usability, electromagnetic compatibility and alarm system amendments in the IEC 60601 series.

Applications and Users

This amendment is essential for:

• Medical device manufacturers designing or updating respiratory gas monitors to meet EU/ISO conformity and CE marking requirements.
• Regulatory and quality teams performing conformity assessment, technical documentation and risk management.
• Test laboratories and clinical engineers conducting accuracy, drift and response-time testing.
• Hospitals and procurement teams evaluating device safety, calibration behavior and infection-control implications.

Related Standards

• IEC 60601-1 series (general medical electrical safety and applicable amendments)
• IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarms)
• IEC 60601-1-11, IEC 60601-1-12
• ISO 80601-2-13 (related respiratory equipment standards)

Keywords: EN ISO 80601-2-55:2018/A1:2023, respiratory gas monitors, medical electrical equipment standard, calibration, measurement accuracy, patient safety, IEC 60601, CE marking, cross‑infection warning.