ISO 18562-1 specifies:
— the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments,
— the general categorization of gas pathways based on the nature and duration of their contact with the gas stream,
— the evaluation of existing relevant data from all sources,
— the identification of gaps in the available data set based on a risk analysis,
— the identification of additional data sets necessary to analyse the biological safety of the gas pathway,
— the assessment of the biological safety of the gas pathway.
ISO 18562-1 covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal conditions. This document does not cover biological hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.
It addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient. This standard applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing).
It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use).
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen-conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouthpieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
ISO 18562-1:2024 text has been approved in Europe as EN ISO 18562-1:2024 without any changes.
