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ISO 15001:2010

Anaesthetic and respiratory equipment - Compatibility with oxygen

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Publication date: 2010-06-01
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ISO 15001:2010 specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa.Additionally, ISO 15001:2010 gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition.Aspects of compatibility that are addressed by ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.ISO 15001:2010 is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.
Document identifier
ISO 15001:2010
Title
Anaesthetic and respiratory equipment - Compatibility with oxygen
ISO Category
TC 121/SC 6: Medical gas systems
Publication date
2010-06-01
Status
Effective
International Relationship
BS EN ISO 15001:2010 * DIN EN ISO 15001 * DIN EN ISO 15001 * BS EN ISO 15001:2011
Cross references
Latest version
ISO 15001:2010
Anaesthetic and respiratory equipment - Compatibility with oxygen
Document identifier ISO 15001:2010
Publication date 2010-06-01
Classification 11.040.10. Anaesthetic, respiratory and reanimation equipment
Status Effective
*
History of version
ISO 15001:2010 * ISO 15001:2003
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Price Contact