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Norma Técnica
Código
ISO 15001:2010  
Data de Publicação : 20/05/2010
Título : Anaesthetic and respiratory equipment -- Compatibility with oxygen
Título Idioma Sec. : Matériel d'anesthésie et de réanimation respiratoire -- Compatibilité avec l'oxygène
Comitê : ISO/TC 121 Anaesthetic and respiratory equipment
Páginas : 40
Status : Em Vigor  
Idioma : Inglês
Organismo : ISO - International Organization for Standardization
Preço (R$) : 1264,00
Objetivo : 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.
Normas Necessárias para a aplicação da ISO 15001:2010
ICS/CIN
11.040.10 - Equipamento de anestesia, de respiração e de reanimação
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