DIN EN ISO 15001:2010-11

In the standard, minimum requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications are specified. This includes medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic work stations and lung ventilators. The requirements apply for pressures greater than 50 kPa. Requirements have been recorded for the level of hydrocarbon and particle contamination and for the resistance to ignition and risk management. The normative part is supplemented by extensive informative annexes with examples of cleaning procedures including their validation, with explanations of the design of oxygen-containing systems, with information on the materials and a recommended test method for the combustion and quantitative analysis of the combustion products of non-metallic materials. In comparison to the August 2004 version, in addition to editorial changes: - the maximum particle size for surfaces of components that come into contact with oxygen during normal operation or single fault condition, has been specified for applications at pressures greater than 3 000 kPa with 100 µm - the requirement has been supplemented that cleaning compounds and methods shall be compatible with the materials, components and devices to be cleaned - requirements for risk management have been revised. An informative annex also contains the correspondence between clauses of the standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices. The standard has been prepared by ISO/TC 121 "Anaesthetic and respiratory equipment" (secretariat: ANSI, USA) in cooperation with CEN/TC 215 "Respiratory and anaesthetic equipment") (secretariat: BSI, United Kingdom) with the participation of German experts. Working Committee NA 053-03-06 AA "Zentrale Gasversorgungsanlagen" ("Central gas supply systems") of NARK is responsible at DIN.