ISO-15001 › Anaesthetic and respiratory equipment - Compatibility with oxygen
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-E4Standard Practices for Force Verification of Testing Machines
ISO-14971
Medical devices - Application of risk management to medical devices
ISO-13485
Medical devices - Quality management systems - Requirements for regulatory purposes
Document Number
ISO 15001:2010
Revision Level
2ND EDITION
Status
Current
Publication Date
June 1, 2010
Committee Number
ISO/TC 121/SC 6