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EN ISO 15001:2011 Standard

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  Keywords:

#standard #international #anaesthetic #compatibility #materials

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

  Purpose

This International Standard 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, this International Standard 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 this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages. This International Standard does not apply to biocompatibility. This International Standard 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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 15001:2010"

Anyway is still possible use the "EN ISO 15001:2010" until April 30th, 2012

  Related Standards

EN 556-1:2001

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN ISO 7886-4:2009

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Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

EN ISO 9360-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HME...

EN ISO 9170-2:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

EN ISO 8835-5:2009

Medical devices Directive (93/42/EEC)

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

EN ISO 8835-4:2009

Medical devices Directive (93/42/EEC)

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

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