ISO 80601-2-55-2018 PDF

Full title and description

ISO 80601-2-55:2018 — Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors. The standard defines particular safety and performance requirements for respiratory gas monitors (RGMs) intended for continuous clinical use, covering anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring; it also clarifies application when the RGM is integrated into other equipment (for example an anaesthetic workstation or ventilator).

Abstract

ISO 80601-2-55:2018 augments the general medical electrical equipment requirements (IEC/ISO 60601 series) with device‑specific requirements that ensure basic safety and essential performance of respiratory gas monitors. It specifies measurement, alarm, sampling, usability and safety requirements for anaesthetic gas analysers, CO2 (capnography) and O2 monitoring equipment; RGMs intended for use with flammable anaesthetic agents are excluded. The standard has an Amendment (Amd 1) published in December 2023.

General information

• Status: Published.
• Publication date: Edition 2 published February 2018 (publication record shows 2018-02-12); Amendment 1 published December 2023.
• Publisher: International Organization for Standardization (ISO); available via national bodies and IEC/ISO webstores.
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 2.0 (2018) with Amendment 1 (2023).
• Number of pages: Main document: 59 pages (2018 edition); Amendment 1: 8 pages.

Scope

The standard specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGMs) intended for continuous operation with a patient. It addresses anaesthetic gas monitoring, carbon dioxide (CO2) monitoring and oxygen (O2) monitoring and applies to RGMs whether they are stand‑alone devices or integrated into larger systems; it does not apply to RGMs intended for use with flammable anaesthetic agents. The document references applicable clauses from IEC 60601‑1 and related parts where hazards from intended physiological function are handled.

Key topics and requirements

• Performance and accuracy requirements for CO2 and O2 measurements, including defined measurement ranges, tolerances and drift/verification criteria for clinical use.
• Requirements for anaesthetic gas analysis (including common volatile anaesthetics), sampling systems, connectors and gas handling to preserve measurement integrity.
• Alarms, alarm limits and human‑factors/usability requirements (aligned with relevant IEC 60601 series requirements for alarm design and usability).
• Safety requirements derived from the IEC 60601 family (electrical, mechanical, thermal safety), plus electromagnetic compatibility (EMC) and immunity considerations for clinical environments.
• Verification, testing and performance validation procedures (type tests and routine tests), calibration/zeroing guidance and recommended test intervals.
• Requirements for labeling, instructions for use, cleaning and maintenance that affect safety and measurement accuracy.

Typical use and users

Primary users include medical device manufacturers, biomedical engineers, clinical users (anesthesiologists, critical care teams), hospital procurement/regulatory personnel and conformity assessment bodies. The standard is used when designing, testing and certifying respiratory gas monitors or when integrating gas monitoring into anaesthesia workstations and ventilators; it is also referenced in clinical procurement and device acceptance testing.

Related standards

ISO 80601-2-55 is part of the IEC/ISO 60601 family of medical electrical equipment standards and explicitly references and augments IEC 60601‑1 (general requirements for basic safety and essential performance). Related parts that are commonly applied alongside this standard include IEC 60601‑1‑2 (EMC), IEC 60601‑1‑8 (alarm systems/usability), and other particular‑part standards for specific medical devices (for example standards covering ventilators or anaesthetic workstations where RGMs are integrated).

Keywords

respiratory gas monitor; RGM; anaesthetic gas analyser; capnography; CO2 monitoring; O2 monitoring; medical electrical equipment; IEC 60601; measurement accuracy; alarms; sampling; clinical safety.

FAQ

Q: What is this standard?

A: ISO 80601-2-55:2018 is the particular‑part standard that defines basic safety and essential performance requirements specifically for respiratory gas monitors used in clinical settings (anaesthetic gas, CO2 and O2 monitoring).

Q: What does it cover?

A: It covers device design and testing requirements for measurement performance, alarms, sampling and gas handling, safety (electrical, mechanical, thermal), EMC considerations, labeling and instructions that together ensure safe, reliable continuous monitoring of respiratory gases. It excludes RGMs intended for use with flammable anaesthetic agents.

Q: Who typically uses it?

A: Manufacturers of respiratory gas monitors and integrated systems, biomedical/clinical engineers, conformity assessment bodies, hospital procurement and clinical teams involved in device selection, testing and use.

Q: Is it current or superseded?

A: The 2018 (Edition 2) document is the current edition for ISO 80601-2-55; it has a published Amendment 1 (2023). The original 2011 edition was withdrawn and superseded by the 2018 edition. The ISO record shows the 2018 edition was last reviewed and confirmed (indicator of currency) and lists a stability date into 2027. For regulatory or design work always check for the latest amendments or national adoptions before relying on a specific clause.

Q: Is it part of a series?

A: Yes — it is a particular‑part of the ISO/IEC 80601 (medical electrical equipment) series and is intended to be read together with the general requirements in IEC 60601‑1 and relevant collateral and particular parts (IEC/ISO 60601 family).

Q: What are the key keywords?

A: Respiratory gas monitor, anaesthetic gas analysis, capnography, CO2, O2, measurement accuracy, alarms, sampling, IEC 60601, medical electrical equipment.