ISO 15001-1:2004 certification

ISO 15000- 12004 instrument is the standard instrument that specifies conditions for the oxygen comity of accoutrements , factors, and bias for anesthetic and respiratory operations, which can come into contact with oxygen in normal conditions or single fault condition at gas pressures lesser than 50 kPa. The anesthetic and respiratory outfit include breathing attachments and anesthetic machines, airways and affiliated outfit, respiratory bias and affiliated outfit used for patient care, medical gas force systems, suction bias, connectors for respiratory remedy bias, and accessories.

Conditions have been recorded for the position of hydrocarbon and flyspeck impurity and the resistance to ignition and threat operation. The normative part is supplemented by expansive instructional additions with exemplifications of drawing procedures including their confirmation, with explanations of the design of oxygen- containing systems, with information on the accoutrements and a recommended test system for the combustion and quantitative analysis of the combustion products ofnon-metallic accoutrements.

ISO 15000- 12004 instrument also gives general guidelines for the selection of accoutrements and factors grounded on available data on their oxygen comity, and for carrying out a threat analysis, including addressing the toxin of products of combustion and/ or corruption. Aspects of comity that are addressed by ISO 15000- 12004 include cleanliness, resistance to ignition, and the toxin of products of combustion and/ or corruption at the design, manufacturing, conservation, and disposal stages. ISO 15000- 12004 doesn't apply to bio comity. It applies to anesthetic and respiratory outfite.g. medical gas channel systems, pressure controllers, terminal units, medical force units, flexible connections, inflow- metering bias, anesthetic workstations, and lung ventilators.

Oxygen, pure or mixed with other medical feasts, is extensively used in medical operations. Because cases and clinical labor force are frequently in close propinquity to bias used with oxygen, the threat of serious injury is high if a fire occurs in an oxygen-fortified atmosphere. A common cause of the fire is the heat produced by adiabatic contraction, and the presence of hydrocarbon and particulate pollutants facilitates ignition. Some combustion products, especially somenon-metals(e.g. plastics, elastomers, and lubricants) are poisonous and therefore cases remote from that outfit and who are entering oxygen from a medical gas channel system might be injured when a problem occurs. Other outfit that's by close propinquity to the outfit using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to serve duly if there's a problem with the oxygen outfit.

Reduction or avoidance of these pitfalls depends on the choice of applicable accoutrements , drawing procedures, and correct design and construction of outfit so that it's compatible with oxygen under the conditions of use. ISO 15000- 12004 gives recommendations for the selection of accoutrements and the cleaning of factors made from them, for use in oxygen and oxygen- amended atmospheres. It's anticipated that particular device norms will make reference to this vertical International Standard and may, if applicable, strengthen these minimal conditions. Particular device norms may specify that some conditions of this International Standard may apply for medical feasts other than oxygen. This International Standard gives recommendations for the selection of accoutrements and the cleaning of factors made from them, for use in oxygen and oxygen- amended atmospheres.