ISO 80601-2-55 Medical Electrical Equipment - Part 2-55: Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors

Medical Device Tests

ISO 80601-2-55 Medical Electrical Equipment - Part 2-55: Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors

EUROLAB laboratory provides testing and compliance services within the scope of ISO 80601-2-55 standard. Developed by the International Organization for Standardization (ISO), this part of the ISO 80601 standard specifies specific requirements for the essential safety and essential performance of a respiratory gas monitor (rgm) intended for continuous use with a patient, hereinafter referred to as me equipment.

ISO 80601-2-55 Medical Electrical Equipment - Part 2-55: Special Requirements for Basic Safety and Basic Performance of Respiratory Gas Monitors

ISO 80601-2-55 specifies requirements for anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. An rgm can be stand-alone equipment or integrated into other equipment, for example an anesthetic workstation or a ventilator.

ISO 80601-2-55 does not apply to an rgm intended for use with flammable anesthetics. Hazards found in the intended physiological function of me equipment or me systems covered by this document are not covered by the special requirements in this document, except for IEC 60601‑1.

If an article or sub-article is specifically intended to apply only to my equipment or only to my systems, the title and content of that article or sub-article will indicate this. If this is not the case, the item or sub-clause applies to both my equipment and my systems, as relevant.

The following printing types are used in the ISO 80601-2-55 standard:

  • Requirements and definitions: novel type.
  • Compliance checks: italic font.
  • Informative material that appears outside the tables, such as notes, examples, and references: smaller type.
  • Terms defined in this document: small caps.

Among the services provided by our organization within the framework of material testing services, there are also ISO 80601-2-55 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

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