Standards Development
This standard applies to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen. This standard applies to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1. The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this standard. Requirements for the supply systems for medical air are given in ISO 7396-1.
These supply systems are referred to in ISO 7396-1 but only a few general requirements are defined in this standard for the supply systems. Manufacturers of these supply systems need a dedicated standard to demonstrate compliance with all applicable requirements (performance, compatibility of the materials with the medical gas produced, mechanical resistance, resistance to inflammation, etc). The manufacturers of these supply systems are not the manufacturers of the pipeline systems. The pipeline systems manufacturers, when purchasing and before installing these supply systems need evidence that all applicable requirements are met by the supply system manufacturer.
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