NF EN ISO 15001

NF EN ISO 15001

May 2012
Standard Current

Anaesthetic and respiratory equipment - Compatibility with oxygen

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2012

Number of pages

53 p.

Reference

NF EN ISO 15001

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-147

Print number

1 - 26/04/2012

International kinship

ISO 15001:2010

European kinship

EN ISO 15001:2011
Sumary
Anaesthetic and respiratory equipment - Compatibility with oxygen

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.

Replaced standards (1)
NF EN ISO 15001
July 2010
Standard Cancelled
Anaesthetic and respiratory equipment - Compatibility with oxygen

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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 * Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Propreté
    2
  • 5 * Résistance à l'inflammation
    3
  • 6 Gestion des risques
    3
  • Annexe A (informative) Exemples de modes opératoires de nettoyage
    5
  • Annexe B (informative) Méthodes habituelles de validation des modes de nettoyage
    13
  • Annexe C (informative) Conception
    16
  • Annexe D (informative) Choix des matériaux
    22
  • Annexe E (informative) Méthode d'essai recommandée pour la combustion et l'analyse quantitative des produits de combustion de matériaux non métalliques
    35
  • Annexe F (informative) Justification
    40
  • Bibliographie
    41
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