ISO DIS 18562-2

Description / Abstract: This part of ISO 18562 specifies tests for the emissions of PARTICULATE MATTER from the GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care to a PATIENT in all environments. The tests of this International Standard are intended to quantify particles from 0,2 μm diameter to 10 μm diameter that are emitted by the equipment into the respirable gas stream. This International Standard establishes acceptance criteria for these tests. This Standard does not address nanoparticles. Insufficient data exists to establish exposure limits for particles less than 0,2 μm in DIAMETER.

NOTE Smaller and larger particles could also present biological hazards, and additional information outside the scope of this standard can be needed to meet requirements of some authorities having jurisdiction.

This International Standard addresses potential contamination of the gas stream arising from the GAS PATHWAYS, which is then conducted to the PATIENT. This Standard applies over the EXPECTED SERVICE LIFE of the MEDICAL DEVICE in NORMAL USE, and should take into account the effects of any intended processing or reprocessing.

This International Standard does not address biological evaluation of the surfaces of GAS PATHWAYS that are in direct contact with the PATIENT. The requirements for direct contact surfaces are found in ISO 10993 (series).

MEDICAL DEVICES, parts or ACCESSORIES, containing breathing GAS PATHWAYS that are addressed by this standard include, but are not limited to ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulisers, low pressure hoses, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing ACCESSORIES intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be breathing GAS PATHWAYS and are also addressed by this standard.

This standard does not address contamination already present in the gas supplied from the gas sources while MEDICAL DEVICES are in NORMAL USE.

EXAMPLES Contamination arriving at the medical device from gas sources such as MEDICAL GAS PIPELINE SYSTEMS (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the MEDICAL DEVICE is not addressed by this series of standards.